Trials (Gustave Roussy)
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NCTID: NCT02666690
Title: Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast Study Summary: RECIST criteria for evaluating tumor response are often inadequate for the evaluation of anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response through the analysis of 7 different parameters. Several studies (four at IGR, involving 117 patients, and a multicenter study involving 400 patients) showed that CEUS allows early evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly interesting for the early identification of patients responding (or not) to treatment. Those are area under curve , and area under the wash-out. To further validate the use of these parameters, it is essential to measure and describe the level of their intra-patient variability. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: CEUS (Contrast-enhanced ultrasound) Start Date: 2011-07 Last Updated: 2016-06-09 Number of Patients: 59 Recruitment Status: COMPLETED Condition: GIST Metastatic Cancer
NCTID: NCT02568267
Title: Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Study Summary: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion. Sponsor: Hoffmann-La Roche Intervention: Entrectinib Start Date: 2015-11-19 Last Updated: 2023-10-06 Number of Patients: 534 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00112697
Title: Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer. PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. Sponsor: UNICANCER Intervention: cisplatin Start Date: 2003-10-06 Last Updated: 2021-02-17 Number of Patients: 71 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT05096390
Title: Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC Study Summary: Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) Sponsor: Centre Leon Berard Intervention: Axitinib Oral Tablet [Inlyta] Start Date: 2022-01-25 Last Updated: 2022-08-29 Number of Patients: 72 Recruitment Status: RECRUITING Condition: Papillary Renal Cell Carcinoma Type 2
NCTID: NCT01516567
Title: Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation Study Summary: Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab Start Date: 2012-04-01 Last Updated: 2021-03-18 Number of Patients: 47 Recruitment Status: UNKNOWN Condition: Primary Mediastinal Large B Cell Lymphoma
NCTID: NCT04498767
Title: Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE) Study Summary: This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers. Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease. The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Stereotactic body radiotherapy Start Date: 2021-06-10 Last Updated: 2023-11-03 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Gynecologic Cancer
NCTID: NCT03943667
Title: Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma Study Summary: This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance. Sponsor: UNICANCER Intervention: Gemcitabine Start Date: 2019-05-23 Last Updated: 2023-11-08 Number of Patients: 211 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Adenocarcinoma
NCTID: NCT03430843
Title: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Study Summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2018-01-26 Last Updated: 2023-01-18 Number of Patients: 513 Recruitment Status: COMPLETED Condition: Esophageal Squamous Cell Carcinoma (ESCC)
NCTID: NCT01303497
Title: Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas Study Summary: Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma Sponsor: Centre Oscar Lambret Intervention: Paclitaxel Start Date: 2010-09-10 Last Updated: 2019-05-30 Number of Patients: 70 Recruitment Status: COMPLETED Condition: Angiosarcoma
NCTID: NCT02400567
Title: Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women Study Summary: The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response evaluation method. In line with the most recent recommendations on targeted anticancer therapies, the investigators have designed a parallel phase II randomized trial with early stopping rules 26, which will able in the meantime to build a unique prospective collection of tumor tissue, pre- and post-treatment. Sponsor: UNICANCER Intervention: Fluorouracile Start Date: 2015-01 Last Updated: 2022-03-15 Number of Patients: 125 Recruitment Status: COMPLETED Condition: Neoadjuvant Operable Breast Cancer
NCTID: NCT02117167
Title: SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients Study Summary: Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2). Sponsor: UNICANCER Intervention: AZD2014 Start Date: 2014-04-23 Last Updated: 2022-08-02 Number of Patients: 999 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer Metastatic
NCTID: NCT00003267
Title: Pelvic Drains After Radical Hysterectomy in Treating Patients With Uterine, Cervical, or Vaginal Cancer Study Summary: RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer. PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: infection prophylaxis and management Start Date: 1998-02 Last Updated: 2012-07-11 Number of Patients: 214 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT02760797
Title: A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors Study Summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in combination in participants with locally advanced or metastatic solid tumors that are not amenable to standard treatment. This study will be conducted in two parts: a dose-finding stage (Part I) and an expansion stage (Part II). Sponsor: Hoffmann-La Roche Intervention: Emactuzumab Start Date: 2016-05-09 Last Updated: 2018-05-22 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT02951767
Title: A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1) Study Summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-05-31 Last Updated: 2023-03-08 Number of Patients: 119 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT00674414
Title: Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery Study Summary: RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery. Sponsor: UNICANCER Intervention: trastuzumab Start Date: 2008-04 Last Updated: 2013-01-18 Number of Patients: 82 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT02444000
Title: gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas Study Summary: Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: PCV chemotherapy alone Start Date: 2015-09-22 Last Updated: 2022-10-26 Number of Patients: 280 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Anaplastic Gliomas With 1p/19q Codeletion
NCTID: NCT01583322
Title: Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer Study Summary: Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib). Sponsor: ARCAGY/ GINECO GROUP Intervention: vargatef Start Date: 2012-06 Last Updated: 2023-09-06 Number of Patients: 188 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04250922
Title: LAM561 With RT and TMZ for Adults With Glioblastoma Study Summary: The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy. Sponsor: Laminar Pharmaceuticals Intervention: LAM561 Start Date: 2019-12-01 Last Updated: 2023-09-29 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Primary Glioblastoma
NCTID: NCT03784014
Title: Molecular Profiling of Advanced Soft-tissue Sarcomas Study Summary: MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large proportion of patients, with results available within reasonnable delays. In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis (next generation sequencing exome, RNASeq <math display="block">NGS</math>) in patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line treatment, participant’s tumor profile of experimental Arm NGS (treatment strategy based on NGS results) will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Participants for whom a targetable genomic alteration has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial. Sponsor Institut National de la Santé Et de la Recherche Médicale, France Intervention: Nilotinib Start Date: 2019-10-19 Last Updated: 2022-10-05 Number of Patients: 960 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT04333914
Title: Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection Study Summary: A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: * COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1). * COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1). Sponsor: Centre Leon Berard Intervention: Autophagy inhibitor (GNS651) Start Date: 2020-04-15 Last Updated: 2022-09-30 Number of Patients: 19 Recruitment Status: COMPLETED Condition: SARS-CoV-2 (COVID-19) Infection
NCTID: NCT04713514
Title: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC Study Summary: The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose). Sponsor: ARCAGY/ GINECO GROUP Intervention: OSE2101 Start Date: 2021-08-05 Last Updated: 2023-09-05 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Platinum-sensitive Ovarian Cancer
NCTID: NCT04707300
Title: Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO) Study Summary: This is an open-labelled and non-controlled Phase I/II clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: Human T Lymphoid Progenitor (HTLP) injection Start Date: 2022-02-16 Last Updated: 2022-11-01 Number of Patients: 10 Recruitment Status: RECRUITING Condition: Hematologic Malignancy
NCTID: NCT03805022
Title: Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas Study Summary: The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up). Sponsor: Institut Bergonié Intervention: Doxorubicin Start Date: 2019-02-14 Last Updated: 2023-03-01 Number of Patients: 351 Recruitment Status: RECRUITING Condition: Non-metastatic Soft-tissue Sarcoma
NCTID: NCT01887522
Title: Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults Study Summary: Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vinblastine + Nilotinib Start Date: 2016-07-06 Last Updated: 2022-05-31 Number of Patients: 144 Recruitment Status: TERMINATED Condition: Refractory Low-grade Gliomas
NCTID: NCT00775385
Title: TAilored Post-Surgical Therapy in Early Stage NSCLC Study Summary: Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib. The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Standard Chemotherapy Start Date: 2009-04 Last Updated: 2017-03-03 Number of Patients: 152 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02780687
Title: Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy Study Summary: The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis. The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR). Sponsor: Boehringer Ingelheim Intervention: Afatinib Start Date: 2016-06-09 Last Updated: 2020-11-18 Number of Patients: 42 Recruitment Status: COMPLETED Condition: Urologic Neoplasms
NCTID: NCT02806687
Title: Effect of Intratumoral Injection of Gene Therapy for Locally Advanced Pancreatic Cancer Study Summary: Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries, and its incidence has increased over the last 40 years. Curative surgery to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of patients is diagnosed with locally advanced tumors and/or metastases because they lack specific symptoms and early markers for this disease. For these patients, palliative armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for PDAC is still very poor and there is great need for new treatments that can change this poor outcome. In this context, the investigators have devised, in the past few years, a highly innovative approach based on therapeutic gene transfer, which does not rely on a specific genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of these promising preclinical data, the investigators conducted past three years the first clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor progression and dissemination. Our results tend to demonstrate therapeutic efficacy, especially in patients with locally advanced tumors. Based on these encouraging results, the investigators propose that patients with locally advanced PDAC at the time of diagnosis may clinically benefit from this approach. This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC. Sponsor: University Hospital, Toulouse Intervention: Gene Therapy product CYL-02 Start Date: 2017-01-30 Last Updated: 2023-03-30 Number of Patients: 68 Recruitment Status: COMPLETED Condition: Pancreatic Adenocarcinoma
NCTID: NCT03037385
Title: Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Study Summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors. Sponsor: Hoffmann-La Roche Intervention: pralsetinib (BLU-667) Start Date: 2017-03-17 Last Updated: 2023-11-27 Number of Patients: 589 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: RET-altered Non Small Cell Lung Cancer
NCTID: NCT02104986
Title: A Multicenter Study to Evaluate a Risk-adapted Strategy for Treatment of Extra Cranial Non Seminomateous Malignant Germ Cell Tumour in Children and Adolescent Study Summary: The main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial NSMGCT in children and adolescent. Sponsor: Centre Leon Berard Intervention: Velbe-Bleomycin-Cisplatin Start Date: 2014-05-12 Last Updated: 2022-08-29 Number of Patients: 117 Recruitment Status: COMPLETED Condition: Extra Cranial Non Seminomateous Malignant Germ Cell Tumour
NCTID: NCT01957787
Title: Study of Cryoablation for Metastatic Lung Tumors Study Summary: The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure. Sponsor: Boston Scientific Corporation Intervention: Cryoablation Start Date: 2014-04-10 Last Updated: 2021-07-19 Number of Patients: 131 Recruitment Status: COMPLETED Condition: Neoplasm Metastasis
NCTID: NCT04115007
Title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients Study Summary: INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients. Sponsor: UNICANCER Intervention: Stereotactic Body Radiotherapy (SBRT) + Standard of care Start Date: 2020-06-23 Last Updated: 2023-02-17 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Oligometastatic Hormone Sensitive Prostate Cancer
NCTID: NCT03635983
Title: A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma Study Summary: The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread Sponsor: Bristol-Myers Squibb Intervention: NKTR-214 Start Date: 2018-09-21 Last Updated: 2023-10-18 Number of Patients: 783 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT03138083
Title: OMO-1 in Solid Malignancies Study Summary: This is a modular, first time in patient, open-label, multicentre study of OMO-1, administered orally, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies. Sponsor: Octimet Oncology N.V. Intervention: OMO-1 Start Date: 2017-08-08 Last Updated: 2020-06-11 Number of Patients: 40 Recruitment Status: TERMINATED Condition: Neoplasms
NCTID: NCT02298283
Title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD Study Summary: This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine). Sponsor: The Lymphoma Academic Research Organisation Intervention: brentuximab vedotin Start Date: 2015-04 Last Updated: 2021-07-26 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT03964233
Title: A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With Ezabenlimab With or Without BI 754111 Study Summary: This study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumors). The second part is open to people with specific types of soft tissue sarcoma, advanced lung cancer, and cancer in the stomach, bladder or bile ducts. The participants get a combination of 2 medicines called BI 907828 and ezabenlimab (also called BI 754091). BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). When the study started, some participants got a third medicine called BI 754111 in addition. Treatment with BI 754111 was stopped because data from another study showed no additional effect of BI 754111. The purpose of the first part of the study is to find out the highest dose of BI 907828 that the participants can tolerate in combination with ezabenlimab. Once the best dose of BI 907828 for the combination with ezabenlimab is found, it will be used in the second part of the study. The purpose of the second part is to see whether the combination of BI 907828 with ezabenlimab is able to make tumors shrink. The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of ezabenlimab, and take tablets with BI 907828 every 3 weeks. The doctors check how many participants have health problems during the study. The doctors also monitor the size of the tumour. Sponsor: Boehringer Ingelheim Intervention: BI 907828 Start Date: 2019-06-11 Last Updated: 2023-10-17 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT03472807
Title: EXOme Rare Cancers in Children (EXOCARE) Study Summary: Other than high-dose radiation and previous chemotherapy, few strong risk factors have been identified as causes of childhood cancer. Geneticists estimate that 5 to 10% of all cancers diagnosed during the paediatric period occur in children born with a genetic mutation, increasing their lifetime risk of neoplasia. Such genetic risk is higher in children with congenital anomalies and specific genetic syndromes. Some germline genetic alterations are well known (e.g. P53 protein (P53), Neurofibromatosis type 1(NF1)), however many children with none of these mutations have clinical presentations that strongly suggest the involvement of a genetic predisposition. Comprehensive genetic testing for all such patients is an important factor for improving disease surveillance. Such opportunities are now available thanks to whole exome sequencing (WES). In oncology, an important clinical application of WES will be to routinely identify mutations associated with inherited cancer predispositions and to guide cancer risk-management decisions. Our project is a national translational multicenter genetics study aimed at identifying genes involved in paediatric cancer predisposition by WES in a very select population of children with both developmental delay and cancer. Our project relies on the TED register (Tumeur Et Développement), an initiative by the French organisation SFCE (Société Française de lutte contre les Cancers et les leucémies de l’Enfant et de l’Adolescent) involving 30 child cancer units in France. This database includes the information of more than 500 paediatric cancer patients with congenital abnormalities. The investigators plan to sequence the germline and tumour exome of 100 patients with developmental delay in a trio-design consisting of 300 people and 100 tumours. The investigators believe that the ExoCaRe project will provide answers to the genetic origins of certain particular childhood cancers. The ExoCaRe project relies on a genetic study to identify genetic risk factors for rare forms of childhood cancer and aims to establish more personalised treatment. It is aimed at improving genetic counselling for families and will be fully integrated in the genetic counselling process. The information provided by our study will be used to improve the management approach to an initial cancer by clarifying the risks of other cancers in related families. The investigators hope to identify new germline genes predisposing to cancer that will be of interest in understanding tumour biology. Sponsor: University Hospital, Angers Intervention: Collection of blood sample or saliva Start Date: 2019-11-13 Last Updated: 2023-11-13 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Predisposition, Genetic
NCTID: NCT02467907
Title: Safety and Efficacy of Bevacizumab in Combination With Carboplatin and Paclitaxel for Metastatic, Recurrent or Persistent Cervical Cancer Study Summary: This study is to assess safety as defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical cancer. In addition, this study will include evaluation of the overall safety profile of bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of efficacy. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2015-07-28 Last Updated: 2019-06-03 Number of Patients: 152 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT05742607
Title: IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE) Study Summary: The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC). Sponsor: Innate Pharma Intervention: IPH5201 + durvalumab + standard chemotherapy Start Date: 2023-06-23 Last Updated: 2023-11-08 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT04817007
Title: A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) Study Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone. Sponsor: Bristol-Myers Squibb Intervention: BMS-986158 Start Date: 2021-03-23 Last Updated: 2023-11-18 Number of Patients: 216 Recruitment Status: RECRUITING Condition: Myelofibrosis
NCTID: NCT00775307
Title: Adjuvant Pazopanib in Stage I NSCLC Study Summary: The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: PAZOPANIB Start Date: 2008-11 Last Updated: 2019-09-24 Number of Patients: 142 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04727307
Title: Neoadjuvant Atezo, Adjuvant Atezo + Beva Combined With RF Ablation of Small HCC: a Multicenter Randomized Phase II Trial Study Summary: Following the results of study IMbrave150, the combination Atezolizumab + Bevacizumab is a promising treatment option for patients with HCC. In addition, the high intrahepatic distant recurrence rate and accumulating evidence for a metastatic mechanism encourages exploring adjuvant
eoadjuvant strategies targeting tumor growth and metastatic escape in the context of percutaneous thermal ablation for small HCC. Local ablation of HCC is therefore an “ideal” setting for testing atezolizumab + bevacizumab in combination with ablation, with the aim of reducing the risk of recurrence.
Sponsor: University Hospital, Montpellier Intervention: Atezolizumab (neoadjuvant) Start Date: 2021-01-26 Last Updated: 2023-08-02 Number of Patients: 202 Recruitment Status: RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT03691207
Title: A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations Study Summary: This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations. Sponsor: Ayala Pharmaceuticals, Inc, Intervention: AL101 Start Date: 2018-12-14 Last Updated: 2021-12-14 Number of Patients: 87 Recruitment Status: UNKNOWN Condition: Adenoid Cystic Carcinoma
NCTID: NCT01900743
Title: Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma Study Summary: This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline). Five cohorts will be defined: Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups. Sponsor: Centre Oscar Lambret Intervention: Regorafenib Start Date: 2013-06-05 Last Updated: 2021-04-09 Number of Patients: 219 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02848443
Title: Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer Study Summary: The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/tipiracil hydrochloride (S 95005) Start Date: 2016-05 Last Updated: 2021-06-30 Number of Patients: 78 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT02302807
Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] Study Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Start Date: 2015-01-13 Last Updated: 2019-08-01 Number of Patients: 931 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT00003683
Title: Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer. Sponsor: UNICANCER Intervention: doxorubicin hydrochloride Start Date: 1998-03 Last Updated: 2021-02-21 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Kidney Cancer
NCTID: NCT04733183
Title: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma Study Summary: Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma. Sponsor: Philogen S.p.A. Intervention: Dacarbazine Start Date: 2020-08-28 Last Updated: 2023-10-10 Number of Patients: 98 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT02867033
Title: National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES) Study Summary: The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort. Sponsor: Centre Oscar Lambret Intervention: biopsy Start Date: 2016-03-22 Last Updated: 2023-02-08 Number of Patients: 628 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Aggressive Fibromatosis
NCTID: NCT04341207
Title: Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients Study Summary: To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Hydroxychloroquine Start Date: 2020-04-03 Last Updated: 2020-04-10 Number of Patients: 1000 Recruitment Status: UNKNOWN Condition: Cancer & COVID 19
NCTID: NCT00410683
Title: Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery Study Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: clinical observation Start Date: 2007-02 Last Updated: 2020-11-20 Number of Patients: 500 Recruitment Status: UNKNOWN Condition: Non-small Cell Lung Cancer
NCTID: NCT01882933
Title: D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma Study Summary: A prospective, opened, multicentric, randomised, phase III trial with two arms: * Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin * Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone. Sponsor: Hospices Civils de Lyon Intervention: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin Start Date: 2013-06 Last Updated: 2023-04-19 Number of Patients: 367 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric Adenocarcinoma
NCTID: NCT01247233
Title: Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer Study Summary: The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management. In this phase III trial, designed in postmenopausal women >50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs. Sponsor: UNICANCER Intervention: Whole Breast Irradiation + Boost or Hypofractionated irradiation Start Date: 2010-12-27 Last Updated: 2023-03-01 Number of Patients: 1006 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01362933
Title: National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients Study Summary: Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH. Sponsor: Floralis Intervention: VTE treatment in cancer patient description Start Date: 2011-05 Last Updated: 2015-03-06 Number of Patients: 502 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT03625037
Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Study Summary: The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human (FIH)) * an expansion part (Phase 2a) * a dose-optimization part (Phase 2a) Sponsor: Genmab Intervention: Epcoritamab Start Date: 2018-06-26 Last Updated: 2023-08-08 Number of Patients: 786 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
NCTID: NCT02046733
Title: Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease Study Summary: Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months. Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC. The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC. Sponsor: ETOP IBCSG Partners Foundation Intervention: Ipilimumab Start Date: 2014-07-28 Last Updated: 2021-02-08 Number of Patients: 174 Recruitment Status: UNKNOWN Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT02654587
Title: Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor Study Summary: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens. Sponsor: OSE Immunotherapeutics Intervention: OSE2101 Start Date: 2016-02 Last Updated: 2021-03-08 Number of Patients: 363 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer
NCTID: NCT04664985
Title: Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer. Study Summary: Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer. Sponsor: Laboratoires IPRAD Intervention: Mucogyne® ovule Start Date: 2020-10-06 Last Updated: 2022-01-03 Number of Patients: 80 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Vaginal Disease
NCTID: NCT04913285
Title: A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors Study Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF
RAS-mutated advanced or metastatic solid tumors.
Sponsor: Kinnate Biopharma Intervention: KIN-2787 Start Date: 2021-08-04 Last Updated: 2023-10-10 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT05625087
Title: Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib Study Summary: After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS). Sponsor: UNICANCER Intervention: Alpelisib Start Date: 2023-10-19 Last Updated: 2023-11-22 Number of Patients: 162 Recruitment Status: RECRUITING Condition: Breast Cancer Stage IV
NCTID: NCT02637687
Title: A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children Study Summary: The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb. Sponsor: Bayer Intervention: Larotrectinib (Vitrakvi, BAY2757556) Start Date: 2015-12-16 Last Updated: 2023-10-31 Number of Patients: 155 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors Harboring NTRK Fusion
NCTID: NCT01784900
Title: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab Study Summary: Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Catumaxomab 100µg Start Date: 2012-11 Last Updated: 2017-01-26 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Patients With Gastric Peritoneal Carcinomatosis
NCTID: NCT02151214
Title: Efficacy of Parenteral Nutrition in Patients at the Palliative Phase of Cancer. Study Summary: In malnourished patients in the palliative phase of cancer, the question is raised of the relevance of implementing artificial nutritional assistance instead of oral feeding when this is possible. Medical prescription and implementation of artificial nutrition at this stage of the illness seem less governed by data acquired by science than by subjective reasons (related to beliefs, to a cultural or religious tradition, to the symbolic role of eating, to the deeply ingrained fear of dying of hunger, to a portrayal of care, etc.) while interacting with teams, the patient and his family and relatives. And yet, the benefits/risk balance and the effect on quality of life of parenteral nutrition in a palliative situation for patients presenting with a normal alimentary tract is poorly understood. The discomfort and risks of central venous or nasogastric artificial nutrition require that the benefits of artificial nutrition be proven. The nature of these benefits relate first and foremost to the quality of life experienced by the patient in such a context. Only a controlled randomized study may lead to an optimal palliative nutritional management of undernutrition to be determined, and to inform the patient and his/her relatives clearly in order for them to express their preferences. We hypothesize that abstaining from artificial parenteral central venous nutrition and associated hydration for nutritional purposes improves quality of life without significant loss of survival compared to implementing artificial nutrition, when considered, in the absence of any specific curative treatment in anorexic patients in the palliative phase of cancer. To test this hypothesis, we propose to carry out a multicenter, prospective, controlled, randomized study in order to evaluate the efficacy of implementing parenteral nutrition compared to abstaining from doing so on the quality of life of undernourished patients in the palliative phase of cancer. The effect on overall survival and the nutritional parameters will be evaluated. The ALIM K trial will be carried out in 13 centres specializing in supportive and onco-hematology care . Sponsor: Centre Hospitalier Universitaire de Besancon Intervention: Parenteral nutrition Start Date: 2012-07-27 Last Updated: 2018-09-17 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Nutrition Aspect of Cancer
NCTID: NCT03675737
Title: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) Study Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil <math display="block">FP regimen</math> or oxaliplatin combined with capecitabine <math display="block">CAPOX regimen</math>) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-11-08 Last Updated: 2023-10-12 Number of Patients: 1579 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Stomach Neoplasms
NCTID: NCT03038100
Title: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study Summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery. Sponsor: Hoffmann-La Roche Intervention: Paclitaxel Start Date: 2017-03-08 Last Updated: 2023-02-17 Number of Patients: 1301 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT05469737
Title: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) Study Summary: The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS). Sponsor: Bristol-Myers Squibb Intervention: Oral Azacitidine Start Date: 2022-12-14 Last Updated: 2023-11-08 Number of Patients: 230 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT02089100
Title: Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer Study Summary: The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: “de novo”, i.e. occurring at first metastatic presentation without any previous systemic therapy; and “secondary”, defined as residual disease after systemic treatment. The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease. This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: stereotactic body radiation therapy Start Date: 2014-02 Last Updated: 2018-07-23 Number of Patients: 280 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT01272037
Title: Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Study Summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer. Sponsor: National Cancer Institute (NCI) Intervention: Anastrozole Start Date: 2011-01-15 Last Updated: 2023-11-14 Number of Patients: 5018 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Ductal Carcinoma In Situ
NCTID: NCT03427814
Title: Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer Study Summary: This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer. Sponsor: BeiGene Intervention: Pamiparib Start Date: 2018-07-03 Last Updated: 2023-09-21 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Advanced or Inoperable Gastric Cancer
NCTID: NCT01493843
Title: Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer Study Summary: This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib. Sponsor: Genentech, Inc. Intervention: pictilisib Start Date: 2012-01-20 Last Updated: 2017-04-25 Number of Patients: 501 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT00144807
Title: ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma Study Summary: This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2003-12 Last Updated: 2015-09-02 Number of Patients: 128 Recruitment Status: COMPLETED Condition: Diffuse Large Cell Lymphoma
NCTID: NCT01765907
Title: Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU) Study Summary: Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU). Sponsor: Theraclion Intervention: HIFU Start Date: 2012-12 Last Updated: 2014-04-16 Number of Patients: 3 Recruitment Status: COMPLETED Condition: Bone Metastasis
NCTID: NCT04674683
Title: Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma Study Summary: This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level. Sponsor: HUYABIO International, LLC. Intervention: HBI-8000 in combination with nivolumab Start Date: 2021-08-12 Last Updated: 2023-07-27 Number of Patients: 480 Recruitment Status: RECRUITING Condition: Unresectable or Metastatic Melanoma
NCTID: NCT02269943
Title: Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Study Summary: The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Participants will be enrolled according to a Simon two-stage design; if the predefined activity is met (>4 responses <math display="block">complete response; partial response {CR/PR}</math> out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. If 4 or less responses out of 17 are observed, then the study enrollment will be stopped.
Sponsor: Celgene
Intervention: CC-486
Start Date: 2015-02-13
Last Updated: 2018-12-12
Number of Patients: 36
Recruitment Status: COMPLETED
Condition: Nasopharyngeal Neoplasms
NCTID: NCT02701907
Title: EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies Study Summary: Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy. Sponsor: UNICANCER Intervention: Blood sampling Start Date: 2016-12 Last Updated: 2022-09-07 Number of Patients: 182 Recruitment Status: COMPLETED Condition: Metastatic Cancers
NCTID: NCT00003643
Title: Combination Chemotherapy in Treating Men With Germ Cell Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer. PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1998-10 Last Updated: 2012-03-06 Number of Patients: 498 Recruitment Status: UNKNOWN Condition: Extragonadal Germ Cell Tumor
NCTID: NCT05233787
Title: Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17) Study Summary: GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses. The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery. Sponsor: University Hospital, Bordeaux Intervention: Tailored use of defunctioning stoma after TME Start Date: 2022-03-24 Last Updated: 2023-08-18 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Rectal Cancer
NCTID: NCT01523587
Title: LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy Study Summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients. Sponsor: Boehringer Ingelheim Intervention: afatinib Start Date: 2012-03-05 Last Updated: 2019-02-15 Number of Patients: 795 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT00054587
Title: Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer. PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm). Sponsor: UNICANCER Intervention: Trastuzumab Start Date: 2001-06 Last Updated: 2013-07-19 Number of Patients: 3010 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02651987
Title: Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Study Summary: This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days. Sponsor: Ipsen Intervention: Lanreotide autogel 120 mg Start Date: 2015-12-15 Last Updated: 2022-10-03 Number of Patients: 99 Recruitment Status: COMPLETED Condition: Pancreatic Tumours
NCTID: NCT05705687
Title: Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors Study Summary: This is a prospective multicenter, non-randomized research program that includes: * a phase IV study (for all patients) with a collection of tissue specimens of tumor, * a phase II study (for patients with primary mediastinal tumors and an unfavorable decline in tumor markers), * and a diagnostic study (for all patients, except patients with brain metastases at baseline or patients for whom any brain MRI is contra-indicated). The main question it aims to answer is improving outcome for young adults with poor-prognosis Non Seminomatous Germ Cell Tumor (NSGCT) is to validate prospectively the efficacy and safety of a personalized treatment based on early tumor marker kinetic assessment in real life for patients with poor-prognosis NSGCT. Participants will be followed-up according to the assessment of decline kinetics of the tumor markers at the end of a first chemotherapy cycle and according to the localisation of the primary lesion if unfavorable. * In the case of a patient with a favorable decline of the tumor markers, he will be treated by 3 additional standard chemotherapy cycles. * In the case of a patient with a testicular or peritoneal primary tumor and an unfavorable decline of the tumor markers, the patient will be treated by a dose-dense standard therapy. * The patient with a mediastinal primary tumor and an unfavorable decline of the tumor markers will be proposed to enter the phase II part of the study or to enter the dose-dense regimen like the other primary localisations. If the patient consents and is eligible for phase II part, he will undergo either an early surgery if feasible or a high-dose chemotherapy if the early surgery is not possible. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: BEP Protocol Start Date: 2023-05-05 Last Updated: 2023-05-18 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Non-Seminomatous Germ Cell Tumor
NCTID: NCT02947685
Title: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Study Summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer. Sponsor: Alliance Foundation Trials, LLC. Intervention: palbociclib Start Date: 2017-06-21 Last Updated: 2023-05-30 Number of Patients: 496 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HER-2 Positive Breast Cancer
NCTID: NCT04262687
Title: Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate Study Summary: About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are “microsatellite unstable” (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX. Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI. The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC. Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a “high” or “low” immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype. Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Capecitabine Start Date: 2021-04-06 Last Updated: 2023-08-18 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Colorectal Cancer Metastatic
NCTID: NCT02866747
Title: A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma Study Summary: This study is a phase I/II, national, multicenter, open-label study starting with a Phase I part followed by a Phase II part. The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part. Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms: * Arm A (control arm): Radiation therapy alone * Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab Sponsor: Institut Claudius Regaud Intervention: Hypofractionated stereotactic radiation therapy Start Date: 2017-01-17 Last Updated: 2023-05-25 Number of Patients: 108 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Glioblastoma
NCTID: NCT01358747
Title: Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL Study Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result. Sponsor: Centre Hospitalier Universitaire Dijon Intervention: BEACOPPesc Start Date: 2011-05 Last Updated: 2014-05-21 Number of Patients: NA Recruitment Status: COMPLETED Condition: Hodgkin’s Lymphoma
NCTID: NCT05102747
Title: Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (310 Gy) to the Historical Single-dose Radiosurgery (120 to 25 Gy) With Medico-economic Evaluation. Study Summary: Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of “oligometastatic” cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared. Sponsor: Centre Francois Baclesse Intervention: Hypofractionated SRT (stereotactic radiotherapy) Start Date: 2022-06-29 Last Updated: 2022-08-10 Number of Patients: 504 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Brain Metastasis
NCTID: NCT03459222
Title: An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread Study Summary: The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types. Sponsor: Bristol-Myers Squibb Intervention: Relatlimab Start Date: 2018-05-30 Last Updated: 2023-09-18 Number of Patients: 255 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Cancer
NCTID: NCT04428047
Title: Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma Study Summary: This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial. This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled. Sponsor: UNICANCER Intervention: bintrafusp alfa Start Date: 2021-02-04 Last Updated: 2022-04-06 Number of Patients: 7 Recruitment Status: TERMINATED Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT01289522
Title: Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Study Summary: PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: cetuximab IV Start Date: 2009-09 Last Updated: 2017-05-15 Number of Patients: 54 Recruitment Status: COMPLETED Condition: Squamous Cell Head and Neck Carcinoma
NCTID: NCT00003122
Title: Surgery in Treating Patients With Neuroblastoma Study Summary: RATIONALE: Surgery may be an effective treatment for neuroblastoma. PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma. Sponsor: Societe Internationale d’Oncologie Pediatrique Intervention: surgical procedure Start Date: 1994-12 Last Updated: 2013-08-26 Number of Patients: 210 Recruitment Status: UNKNOWN Condition: Neuroblastoma
NCTID: NCT03406247
Title: Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma Study Summary: Two randomized trials of reirradiation after salvage surgery have been conducted by the GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first trial compared reirradiation and a “wait and see attitude” and was published in 2008 <math display="block">1</math>. The second trial compared two modalities of reirradiation. Our hypothesis is that adjuvant treatment with immunotherapy will lead to a DFS similar to that observed in previous trials of post-operative reirradiation with possibly lower toxicity. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nivolumab Start Date: 2018-02-12 Last Updated: 2023-05-19 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT04821622
Title: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Study Summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. Sponsor: Pfizer Intervention: talazoparib plus enzalutamide Start Date: 2021-05-12 Last Updated: 2023-11-22 Number of Patients: 599 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT00820547
Title: Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients Study Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer. Sponsor: UNICANCER Intervention: bevacizumab Start Date: 2009-01 Last Updated: 2019-10-22 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01864850
Title: Non Inferiority Trial of Standard RT Versus Hypofractionated Split Course in Elderly Vulnerable Patients With HNSCC Study Summary: Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Standard RT Start Date: 2013-10-18 Last Updated: 2023-09-22 Number of Patients: 202 Recruitment Status: COMPLETED Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT01834950
Title: Identification of Early Markers of Response and Resistance to Trastuzumab Study Summary: The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Blood test Start Date: 2013-03-27 Last Updated: 2018-03-29 Number of Patients: 25 Recruitment Status: COMPLETED Condition: Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer
NCTID: NCT03745950
Title: UTOLA: UTerin OLAparib Study Summary: This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer Sponsor: ARCAGY/ GINECO GROUP Intervention: Olaparib Oral Capsule Start Date: 2019-02-01 Last Updated: 2023-11-07 Number of Patients: 147 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Carcinoma
NCTID: NCT03549715
Title: NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma Study Summary: This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC. Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie Intervention: Durvalumab Start Date: 2018-12-06 Last Updated: 2022-04-28 Number of Patients: 121 Recruitment Status: RECRUITING Condition: Infiltrating Bladder Urothelial Carcinoma
NCTID: NCT00006050
Title: Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver. Sponsor: UNICANCER Intervention: FOLFOX regimen Start Date: 1999-04-04 Last Updated: 2021-02-17 Number of Patients: NA Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02234050
Title: Trabectedin for Recurrent Grade II/III Meningioma Study Summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Trabectedin Start Date: 2015-07 Last Updated: 2019-02-28 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Recurrent High Grade Meningioma
NCTID: NCT01737450
Title: Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive Study Summary: The aim of this study is to determine the activity, to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under platin and cetuximab-based chemotherapy. Sponsor: Centre Leon Berard Intervention: BKM120 Start Date: 2013-01 Last Updated: 2019-06-24 Number of Patients: 58 Recruitment Status: COMPLETED Condition: Head and Neck Neoplasms
NCTID: NCT04924075
Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-08-12 Last Updated: 2023-11-27 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Pheochromocytoma/Paraganglioma
NCTID: NCT02444390
Title: Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor Study Summary: This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane are prescribed within their approved indication as per usual practice and are not part of this trial. Sponsor: UNICANCER Intervention: Biopsy Start Date: 2015-05-19 Last Updated: 2022-09-21 Number of Patients: 150 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT00094497
Title: Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) Study Summary: The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection. Sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment Intervention: Etoposide Start Date: 2004-06 Last Updated: 2016-09-21 Number of Patients: 304 Recruitment Status: COMPLETED Condition: Carcinoma, Adrenal Cortical
NCTID: NCT01282697
Title: Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors Study Summary: Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and could, in some cases, stop its progression. This drug combination has already been tested in adult patients with refractory tumors and seems to give encouraging results with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when these drugs are administered separately and in a context different from that of refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the maximum dose at which these two molecules may be administered and to assess the safety of this new combination of drugs. Sponsor: University Hospital, Strasbourg, France Intervention: Combined administration of irinotecan and rapamycin Start Date: 2011-04-22 Last Updated: 2019-12-09 Number of Patients: 42 Recruitment Status: COMPLETED Condition: Refractory Solid Tumors in Children
NCTID: NCT04758767
Title: CID-103 (Anti-CD38 Antibody) in Previously Treated Relapsed or Refractory Multiple Myeloma Study Summary: Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities. Sponsor: CASI Pharmaceuticals, Inc. Intervention: CID-103 Start Date: 2021-03-22 Last Updated: 2023-03-02 Number of Patients: 10 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT03419897
Title: Study of BGB-A317 in Participants With Previously Treated Unresectable HCC Study Summary: This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2018-04-09 Last Updated: 2023-07-27 Number of Patients: 249 Recruitment Status: COMPLETED Condition: Hepatocellular Carcinoma (HCC)
NCTID: NCT03723967
Title: FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel Study Summary: The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy. Sponsor: Centre Leon Berard Intervention: Durvalumab with Carboplatin/Paclitaxel Start Date: 2019-05-16 Last Updated: 2022-10-04 Number of Patients: 102 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT02920697
Title: Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma Study Summary: The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy. Sponsor: Institut de Recherches Internationales Servier Intervention: S 55746 Start Date: 2014-03 Last Updated: 2019-11-25 Number of Patients: 65 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukaemia (CLL)
NCTID: NCT03217097
Title: MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents Study Summary: Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY) are one of the main systemic treatments used, at least for advanced duodeno-pancreatic NETs, with a response rate of 30 to 40% and a median progression-free survival of 4 to 18 months. Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin analogs, and metabolic radiotherapy, for lung NETs, called typical and atypical carcinoids, even if the level of proof of efficacy for these treatments is lower than for duodeno-pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY. Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17% and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more recently that its activity is similar to that of ALKYs, but without being influenced by the MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be offered first to patients with unmethylated MGMT tumors. In this project, we wish to evaluate the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective Response (OR) in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET. Sponsor: Hospices Civils de Lyon Intervention: Oxaliplatin-based chemotherapy Start Date: 2018-10-16 Last Updated: 2022-11-04 Number of Patients: 116 Recruitment Status: COMPLETED Condition: Neuroendocrine Tumors
NCTID: NCT04305054
Title: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) Study Summary: Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy. Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-07-01 Last Updated: 2023-11-24 Number of Patients: 315 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT04987203
Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Study Summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib Start Date: 2021-09-09 Last Updated: 2023-11-28 Number of Patients: 326 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT03725059
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab (K) Start Date: 2018-12-27 Last Updated: 2023-09-28 Number of Patients: 1240 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00412503
Title: Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents Study Summary: Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas
euroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Topotecan, Temozolomide Start Date: NA Last Updated: 2009-08-07 Number of Patients: NA Recruitment Status: COMPLETED Condition: Refractory Tumors
NCTID: NCT01962103
Title: Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors Study Summary: The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen, patients will be enrolled according to the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing’s sarcoma), to see how nab-paclitaxel works in treating these tumors. Sponsor: Celgene Intervention: nab-paclitaxel Start Date: 2013-12-04 Last Updated: 2019-12-27 Number of Patients: 107 Recruitment Status: COMPLETED Condition: Neuroblastoma
NCTID: NCT03088059
Title: Biomarker-based Study in R/M SCCHN Study Summary: This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Afatinib Start Date: 2017-11-16 Last Updated: 2023-11-03 Number of Patients: 340 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Squamous Cell of Head and Neck
NCTID: NCT04823403
Title: Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma Study Summary: To determine the Maximum Tolerated Dose (MTD), and the recommended Phase 2 dose of HIA Ipilimumab in combination with IV Nivolumab by monitoring the Dose Limiting Toxicity (DLT) within 1 month after IA Ipilimumab administration in dose-escalation phase. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nivolumab Start Date: 2020-11-13 Last Updated: 2023-02-14 Number of Patients: 27 Recruitment Status: RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT04049903
Title: Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid Tumors Study Summary: To evaluate the safety and tolerability of MP0310, a DARPin® therapeutic candidate for tumor targeted activation of T cells, in patients with advanced solid tumors Sponsor: Molecular Partners AG Intervention: MP0310 Start Date: 2019-09-02 Last Updated: 2022-12-22 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Advanced Solid Tumor
NCTID: NCT00811759
Title: Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma Study Summary: RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: sorafenib tosylate Start Date: 2007-06 Last Updated: 2010-10-07 Number of Patients: 58 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT02044354
Title: Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer Study Summary: Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles. Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting. The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib. A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future. Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Taxotere Start Date: 2014-05-22 Last Updated: 2017-08-08 Number of Patients: 195 Recruitment Status: UNKNOWN Condition: Metastatic Castration-resistant Prostate Cancer
NCTID: NCT04289259
Title: Tumor Mutational Burden in Lung Cancer Patients Study Summary: Tumor mutational burden (TMB) seems to be is an important marker for immune checkpoint inhibitors efficacy. This study aims to assess the feasibility of the TMB assessment in first-line lung cancer in routine practice both on biopsy and surgical tumor samples. Results will be an element of discussion for the generalization of the TMB implementation in cancer centers. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: TMB assessment Start Date: 2020-06-10 Last Updated: 2021-06-24 Number of Patients: 6 Recruitment Status: TERMINATED Condition: Non Small Cell Lung Cancer
NCTID: NCT05947903
Title: Validation of the European Oncology Quality of Life Toolkit Study Summary: The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: * The primary aim is to perform the psychometric validation of the EUonQoL-Kit. * Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries. The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: * EORTC QLQ-C30, to test concurrent validity. * Live-CAT version, to test the feasibility of such implementation. * EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Administration of the EUonQoL-Kit - Active Treatment questionnaire Start Date: 2024-04-01 Last Updated: 2023-07-19 Number of Patients: 4000 Recruitment Status: NOT_YET_RECRUITING Condition: Cancer
NCTID: NCT05155254
Title: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) Study Summary: Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival. Sponsor: IO Biotech Intervention: IO102-IO103 Start Date: 2022-05-17 Last Updated: 2023-09-13 Number of Patients: 380 Recruitment Status: RECRUITING Condition: Metastatic Melanoma
NCTID: NCT00052754
Title: Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma Study Summary: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: gefitinib Start Date: 2002-10 Last Updated: 2012-09-24 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT03697850
Title: Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy Study Summary: Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient’s refusal. This study is designed as a multicentre, single-arm phase II study. Sponsor: UNICANCER Intervention: Atezolizumab Start Date: 2018-12-14 Last Updated: 2023-11-13 Number of Patients: 79 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Bladder Cancer
NCTID: NCT03435250
Title: Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss Study Summary: This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion. Sponsor: Institut de Recherches Internationales Servier Intervention: AG-270 Start Date: 2018-03-04 Last Updated: 2023-10-11 Number of Patients: 123 Recruitment Status: TERMINATED Condition: Advanced Solid Tumors
NCTID: NCT04822350
Title: A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA Study Summary: A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients. Sponsor: Pfizer Intervention: Avelumab Start Date: 2021-07-13 Last Updated: 2023-08-07 Number of Patients: 600 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT02643550
Title: Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Study Summary: The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1 Sponsor: Innate Pharma Intervention: Monalizumab Start Date: 2015-12 Last Updated: 2023-05-12 Number of Patients: 143 Recruitment Status: COMPLETED Condition: Head and Neck Neoplasms
NCTID: NCT04459715
Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2020-08-07 Last Updated: 2023-10-24 Number of Patients: 730 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT01045915
Title: Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma Study Summary: The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man. Sponsor: Onxeo Intervention: naked DNA coding for protein AMEP Start Date: 2010-07 Last Updated: 2015-09-11 Number of Patients: 5 Recruitment Status: TERMINATED Condition: Melanoma
NCTID: NCT01078415
Title: Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC) Study Summary: The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC). Sponsor: Angiodynamics, Inc. Intervention: Ablation with the NanoKnife Low Energy Direct Current (LEDC) System Start Date: 2010-02 Last Updated: 2016-11-08 Number of Patients: 26 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT05403450
Title: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) Study Summary: The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2. Sponsor: Astex Pharmaceuticals, Inc. Intervention: Tolinapant Start Date: 2022-06-23 Last Updated: 2023-09-01 Number of Patients: 132 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Peripheral T-cell Lymphoma
NCTID: NCT00568750
Title: Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors Study Summary: RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors. Sponsor: Swiss Group for Clinical Cancer Research Intervention: dasatinib Start Date: 2008-01-22 Last Updated: 2019-06-17 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumor
NCTID: NCT00004150
Title: High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer. PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer. Sponsor: Robert Roessle Klinik Intervention: fluorouracil Start Date: 1999-03 Last Updated: 2013-11-06 Number of Patients: NA Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03767075
Title: A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets) Study Summary: The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks. The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles. The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight < 80 kg and 1400 mg for body weight >= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles). Sponsor: Vall d’Hebron Institute of Oncology Intervention: Atezolizumab Start Date: 2018-12-10 Last Updated: 2023-06-12 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT04704154
Title: A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors Study Summary: Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts. The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion). The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years. During the trial, the doctors will take pictures of the participants’ tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants’ heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems. Sponsor: Bayer Intervention: Regorafenib, (Stivarga, BAY73-4506) Start Date: 2021-02-03 Last Updated: 2023-11-28 Number of Patients: 175 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT06022159
Title: A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or “Fragile” (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa. Study Summary: This is a phase II, multicenter, non-randomized study. The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant and adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as “fragile” and treated for soft tissue sarcoma. A maximum of 70 patients will be included in this study, divided in 2 groups (35 patients per arms): a neo-adjuvant cohort and an adjuvant cohort. In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior to surgery. In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated radiation therapy. Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery or surgery + radiotherapy). Sponsor: Institut Claudius Regaud Intervention: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery. Start Date: 2023-11 Last Updated: 2023-11-08 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT04064359
Title: Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors Study Summary: The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an “Investigational Drug”, which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness. Sponsor: Oxford BioTherapeutics Ltd Intervention: OBT076, a CD205-directed antibody-drug conjugate Start Date: 2019-07-25 Last Updated: 2023-10-12 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT01112254
Title: Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer Study Summary: The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: MRI±biopsy Start Date: 2010-02 Last Updated: 2016-01-26 Number of Patients: 360 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00103168
Title: Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor Study Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor. PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: imatinib mesylate Start Date: 2004-12 Last Updated: 2018-07-09 Number of Patients: 908 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumor
NCTID: NCT00104715
Title: Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer Study Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer. Sponsor: UNICANCER Intervention: antiandrogen therapy Start Date: 2004-10-18 Last Updated: 2021-02-21 Number of Patients: 385 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01504815
Title: Adaptive Radiation Treatment for Head and Neck Cancer Study Summary: This Phase III trial aims to: Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN. The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area. To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution. Sponsor: The Netherlands Cancer Institute Intervention: cisplatinum Start Date: 2012-03 Last Updated: 2023-07-06 Number of Patients: 268 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Cancer
NCTID: NCT03703050
Title: Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2) Study Summary: Prospective, non-randomized, single arm phase II trial with 2 cohorts of ALK+ ALCL treated with nivolumab Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nivolumab cohort 1 Start Date: 2019-01-02 Last Updated: 2023-10-10 Number of Patients: 38 Recruitment Status: RECRUITING Condition: Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma
NCTID: NCT04253015
Title: A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta Study Summary: This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety. Sponsor: EusaPharma (UK) Limited Intervention: Data-collection Start Date: 2019-09-30 Last Updated: 2023-06-13 Number of Patients: 125 Recruitment Status: RECRUITING Condition: Neuroblastoma
NCTID: NCT02271659
Title: Medical and Economic Evaluation for Intermediate-risk Prostate Cancer Study Summary: The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years. Sponsor: Hospices Civils de Lyon Intervention: Brachytherapy boost with external beam radiotherapy Start Date: 2013-06 Last Updated: 2016-09-13 Number of Patients: 298 Recruitment Status: UNKNOWN Condition: Prostate Cancer
NCTID: NCT04747054
Title: Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers Study Summary: Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head & neck cancers Sponsor: UNICANCER Intervention: Pembrolizumab Start Date: 2021-12-01 Last Updated: 2023-10-13 Number of Patients: 148 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04428554
Title: Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy Study Summary: This is a phase II, multicenter, randomized open-label and comparative study designed to evaluate whether local consolidative radiotherapy plus standard of care improves overall survival as compared to standard of care in patients with limited metastatic urothelial bladder cancer and without progression following the initial phase of first-line systemic therapy. Each patient will be followed during 4 years from the date of randomization. Sponsor: Institut Claudius Regaud Intervention: Experimental arm Start Date: 2020-06-30 Last Updated: 2023-09-21 Number of Patients: 130 Recruitment Status: RECRUITING Condition: Urothelial Bladder Cancer
NCTID: NCT04950075
Title: Study of INBRX-109 in Conventional Chondrosarcoma Study Summary: Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. Sponsor: Inhibrx, Inc. Intervention: INBRX-109 Start Date: 2021-09-23 Last Updated: 2023-11-08 Number of Patients: 201 Recruitment Status: RECRUITING Condition: Conventional Chondrosarcoma
NCTID: NCT04172675
Title: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Study Summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2020-02-28 Last Updated: 2023-11-13 Number of Patients: 107 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT03869190
Title: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) Study Summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-06-01 Last Updated: 2023-11-13 Number of Patients: 645 Recruitment Status: RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT05503797
Title: A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations Study Summary: The objective of this study is to evaluate the efficacy of FORE8394 in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with recurrent high-grade glioma (HGG) harboring BRAF V600E mutation. This will be conducted as two single arm open-label subprotocols (F8394-201A; F8394-201B) under one master protocol. Sponsor: Fore Biotherapeutics Intervention: FORE8394 Start Date: 2023-02-21 Last Updated: 2023-08-04 Number of Patients: 135 Recruitment Status: RECRUITING Condition: Cancer Harboring BRAF Alterations
NCTID: NCT02384759
Title: Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers Study Summary: This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for strategic studies evaluating the usefulness of including targeted therapeutics from the first line with aflibercept +/- LV5FU2. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: aflibercept Start Date: 2015-05 Last Updated: 2022-04-04 Number of Patients: 117 Recruitment Status: COMPLETED Condition: Colorectal Neoplasms
NCTID: NCT00935675
Title: Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment Study Summary: Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score > 11 Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Escitalopram Start Date: NA Last Updated: 2009-09-02 Number of Patients: 100 Recruitment Status: UNKNOWN Condition: Carcinomas
NCTID: NCT05407675
Title: A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors Study Summary: The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined. Sponsor: Bristol-Myers Squibb Intervention: BMS-986408 Start Date: 2022-08-02 Last Updated: 2023-10-17 Number of Patients: 113 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT01880359
Title: AF CRT +/- Nimorazole in HNSCC Study Summary: The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from this class are used against infection. In addition, nimorazole makes tumor cells more sensitive to radiotherapy. Therefore, the investigators want to find out whether the addition of nimorazole to the standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows activity against your type of head and neck cancer and is safe. Furthermore the investigators will investigate if a specific examination done with your tumor tissue will help to predict whether the treatment will work or not. To find out if the activity observed with this treatment is not caused by chance alone, the investigators need to obtain data from patients who receive this treatment and from patients who receive other treatments. The data from these two groups of patients will be compared to see which treatment is better. Participants will be split into 2 groups. Each group will receive different treatments. The treatment each group receives is determined by chance using a computer program. This works like flipping a coin and is called randomization. This helps to make sure that groups of patients are similar when the study starts. Neither you, your study doctor, nor the study staff can influence in which group you will be placed or which treatment you will receive. If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy with cisplatin and nimorazole as a pill. This is considered the ‘experimental’ treatment. If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy with cisplatin and a so called ‘placebo’ as a pill. The placebo is a dummy treatment. It looks like the real one, but it is not. It contains no active ingredient/medicine. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Cisplatin Start Date: 2014-07-25 Last Updated: 2022-05-10 Number of Patients: 640 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced Head and Neck HPV Negative Squamous Cell Cancers
NCTID: NCT00535275
Title: NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy Study Summary: Relapses after perioperative chemotherapy and surgery Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Chemotherapy with platine Start Date: 2007-09 Last Updated: 2015-02-16 Number of Patients: 88 Recruitment Status: TERMINATED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT00274859
Title: Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: gemcitabine hydrochloride Start Date: 2005-08 Last Updated: 2008-07-24 Number of Patients: 45 Recruitment Status: UNKNOWN Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT02508467
Title: A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma Study Summary: This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of fisogatinib (formerly known as BLU- 554) administered orally in patients with FGF19 IHC+ hepatocellular carcinoma (HCC). The study consists of 3 parts, a dose-escalation part (Part 1), an expansion part (Part 2) exploring a once daily (qd) dosing schedule at the recommended Phase 2 dose (RP2D), and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients. Sponsor: Blueprint Medicines Corporation Intervention: Fisogatinib (BLU-554) Start Date: 2015-07-31 Last Updated: 2023-02-08 Number of Patients: 150 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hepatocellular Carcinoma (HCC)
NCTID: NCT01827267
Title: Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer Study Summary: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2013-07-01 Last Updated: 2018-07-03 Number of Patients: 62 Recruitment Status: COMPLETED Condition: HER2-mutant Non-Small Cell Lung Cancer
NCTID: NCT02871167
Title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation Study Summary: The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area. Sponsor: Centre Oscar Lambret Intervention: Controlled ovarian hyperstimulation (COH) Start Date: 2016-12 Last Updated: 2023-02-14 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT02098343
Title: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 Study Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients. Sponsor: Aprea Therapeutics Intervention: APR-246 Start Date: 2014-03 Last Updated: 2022-10-13 Number of Patients: 247 Recruitment Status: COMPLETED Condition: Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53
NCTID: NCT05651867
Title: EPIONE Guided Lung Evaluation Study Summary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung. Sponsor: Quantum Surgical Intervention: EPIONE device Start Date: 2022-11-28 Last Updated: 2023-09-14 Number of Patients: 25 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer
NCTID: NCT01390948
Title: A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Study Summary: This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms. Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2011-10-18 Last Updated: 2020-08-06 Number of Patients: 124 Recruitment Status: COMPLETED Condition: High Grade Glioma
NCTID: NCT03519048
Title: Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma Study Summary: Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nasofibroscopy Start Date: 2018-01-17 Last Updated: 2023-01-23 Number of Patients: 197 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT01826448
Title: A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma Study Summary: The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma. Sponsor: Daiichi Sankyo, Inc. Intervention: PLX3397 Start Date: 2013-11-05 Last Updated: 2020-05-28 Number of Patients: 13 Recruitment Status: TERMINATED Condition: V600-mutated BRAF Unresectable Melanoma
NCTID: NCT01459003
Title: Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer Study Summary: Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: beauty care Start Date: 2011-10 Last Updated: 2014-05-06 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01564056
Title: Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment Study Summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test. Sponsor: UNICANCER Intervention: HORMONOTHERAPY Start Date: 2012-04-12 Last Updated: 2023-04-06 Number of Patients: 1989 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00002903
Title: Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: docetaxel Start Date: 1995-07 Last Updated: 2012-07-02 Number of Patients: 25 Recruitment Status: COMPLETED Condition: Extragonadal Germ Cell Tumor
NCTID: NCT00651456
Title: Mesothelioma Avastin Plus Pemetrexed-cisplatin Study Study Summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Standard Chemotherapy (Pemetrexed and Cisplatin) Start Date: 2008-02 Last Updated: 2023-03-13 Number of Patients: 448 Recruitment Status: COMPLETED Condition: Mesothelioma
NCTID: NCT04976556
Title: Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope Study Summary: Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device. Sponsor: SamanTree Medical SA Intervention: Histolog Scanner Start Date: 2019-06-26 Last Updated: 2023-06-15 Number of Patients: 181 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02721056
Title: NBTXR3 Crystalline Nanoparticles and Stereotactic Body Radiation Therapy in the Treatment of Liver Cancers Study Summary: The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers. Sponsor: Nanobiotix Intervention: NBTXR3, IL or IA injection + SBRT Start Date: 2016-01-28 Last Updated: 2021-05-10 Number of Patients: 23 Recruitment Status: TERMINATED Condition: Liver Cancer
NCTID: NCT00162656
Title: Treatment of Mature B-cell Lymphoma/Leukaemia Study Summary: This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether “reduced” therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: half cyclophosphamide Start Date: 1996-05 Last Updated: 2012-03-28 Number of Patients: 848 Recruitment Status: COMPLETED Condition: B-Cell Lymphoma
NCTID: NCT00828386
Title: Induction Chemotherapy and Chemoradiotherapy in Nasopharyngeal Cancers Study Summary: This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Induction chemotherapy + concurrent radiochemotherapy vs. concurrent radiochemotherapy Start Date: 2009-01 Last Updated: 2019-01-18 Number of Patients: 83 Recruitment Status: TERMINATED Condition: Nasopharyngeal Cancers
NCTID: NCT01844986
Title: Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. Study Summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy. Sponsor: AstraZeneca Intervention: Olaparib 300mg tablets Start Date: 2013-08-26 Last Updated: 2023-11-28 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Newly Diagnosed
NCTID: NCT03834519
Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5’-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: # Overall Survival (OS) and # Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-11-07 Number of Patients: 793 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT04197986
Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. Sponsor: QED Therapeutics, Inc. Intervention: Infigratinib Start Date: 2020-03-11 Last Updated: 2023-02-02 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Upper Tract Urothelial Carcinomas
NCTID: NCT05525286
Title: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma Study Summary: This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (mFOLFOX6 with nivolumab and nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced inoperable or metastatic gastric/GEJ adenocarcinoma or inoperable or metastatic pancreatic adenocarcinoma. Sponsor: Sotio Biotech Inc. Intervention: SOT102 Start Date: 2022-03-31 Last Updated: 2023-11-28 Number of Patients: 269 Recruitment Status: SUSPENDED Condition: Gastric Cancer
NCTID: NCT00138086
Title: Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma Study Summary: The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS). The goal is to obtain a 15% increase of EFS at 2 years. Sponsor: Lymphoma Study Association Intervention: Zevalin plus BEAM Start Date: 2005-03 Last Updated: 2006-09-08 Number of Patients: 75 Recruitment Status: COMPLETED Condition: B-Cell Lymphoma
NCTID: NCT04704219
Title: Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) Study Summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-02-23 Last Updated: 2023-08-29 Number of Patients: 152 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT02977156
Title: Immunization Strategy With Intra-tumoral Injections of Pexa-Vec With Ipilimumab in Metastatic / Advanced Solid Tumors. Study Summary: The success of anti-CTLA4 therapy has inaugurated a paradigm shift in oncology where drugs target the immune system rather than cancer cells in order to stimulate the anti-tumor immune response. In situ immunization is a strategy where immunomodulatory products such as pathogens are injected into one tumor site in order to trigger a systemic anti-tumor immune response. Of importance, pre-clinical rationale has demonstrated that combination of anti-CTLA4 therapy together with intra-tumoral (IT) oncolytic virus can overcome primary resistance to systemic anti-CTLA4 therapy. Pexastimogene Devacirepvec (Pexa-Vec) is one of the new vaccinia oncolytic viruses genetically modified to express GM-CSF. This new and innovative oncolytic virotherapy should therefore synergize with anti-CTLA4 therapy via virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg blockade/depletion. Intra-tumoral delivery of immunostimulating agents should, therefore, provide lower toxicity of mAb targeting immune checkpoints. Of note, IT injections of GM-CSF-encoding oncolytic viruses have already been shown to induce immune-mediated tumor responses on local (injected) and distant (not injected) tumor sites. In solid injectable refractory/relapsing metastatic tumors, we make the hypothesis that the addition of Pexa-Vec to IT ipilimumab (anti-CTLA4 Ab) will overcome primary/secondary resistance to standard therapy and/or immunotherapy with a better in situ tumor antigen specific T-cell priming. Our proposal is to conduct a 2-part Phase I clinical trial in order to define the feasibility, the safety and the anti-tumor effects of intra-tumoral injections of ipilimumab in combination with the oncolytic virus Pexa-Vec. Dose escalation step will define the MTD and RP2D of that in situ immunization strategy. Expansion part will assess the anti-tumor effect of the combination. Sponsor: Centre Leon Berard Intervention: Pexa-Vec Start Date: 2017-01-03 Last Updated: 2022-07-25 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Metastatic Tumor
NCTID: NCT03443856
Title: Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence Study Summary: The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection. Other study objectives: * To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study * To correlate nutritional status assessment on outcomes and quality of life of patients Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab and Ipilimumab Start Date: 2019-07-17 Last Updated: 2023-09-07 Number of Patients: 197 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric and Esophagogastric Junction Adenocarcinoma
NCTID: NCT03333356
Title: Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30) Study Summary: This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection. The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment. Sponsor: UNICANCER Intervention: pelvic radiotherapy Start Date: 2018-04-19 Last Updated: 2023-11-13 Number of Patients: 109 Recruitment Status: RECRUITING Condition: Patients With High-risk MIBC
NCTID: NCT03244956
Title: Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer Study Summary: This is a multicentric prospective non-randomized phase II trial, with two independent arms: one for patients with RAS mutation and one for patients with BRAFV600E mutation. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Trametinib Start Date: 2017-12-27 Last Updated: 2021-09-28 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients With RAS or BRAF Mutation
NCTID: NCT02129556
Title: Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer Study Summary: Panacea is a phase Ib/II trial evaluating the efficacy of MK-3475 and trastuzumab in patients with trastuzumab-resistant, HER2- positive metastatic breast cancers Sponsor: ETOP IBCSG Partners Foundation Intervention: MK-3475 Start Date: 2014-12 Last Updated: 2019-02-15 Number of Patients: 58 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT02383251
Title: Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer Study Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance. Sponsor: ARCAGY/ GINECO GROUP Intervention: Pazopanib Start Date: 2015-06-15 Last Updated: 2023-09-06 Number of Patients: 118 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT00435851
Title: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients Study Summary: In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff. Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Thyrogen, thyroid hormone withdrawal, iode 131 Start Date: 2007-02 Last Updated: 2007-02-19 Number of Patients: 950 Recruitment Status: UNKNOWN Condition: Thyroid Cancer
NCTID: NCT00547651
Title: AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy Study Summary: This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer. Sponsor: Celgene Intervention: Amrubicin Start Date: 2007-09-01 Last Updated: 2019-11-06 Number of Patients: 637 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT04428151
Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) Study Summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-08-06 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT03212651
Title: Study Evaluating Neoadjuvant Pembrolizumab Monotherapy in Patients With Muscle-Invasive Bladder Cancer to Explore in Vivo the Mechanisms of Action of Pembrolizumab Study Summary: monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2; Recent phase I trial provided evidence of activity of pembrolizumab in advanced platinum-resistant metastatic urothelial carcinoma; Recent phase 3 trial showed an overall survival benefit in patients treated with pembrolizumab in a trial comparing pembrolizumab to chemotherapy in patients who failed first-line platinum-based chemotherapy Neoadjuvant chemotherapy followed by radical cystectomy is the standard of care for cisplatinum-eligible non-metastatic MIBC patients; Many patients with MIBC are unfit for cisplatin-based combination treatment; Given its safety profile, pembrolizumab may be used in unfit patients; Neo-adjuvant setting is a unique opportunity to assess mechanisms of action of pembrolizumab in human Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Pembrolizumab Start Date: 2017-10-17 Last Updated: 2023-01-20 Number of Patients: 41 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04779151
Title: Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab Study Summary: Treatment will consist of a PARP inhibitor (niraparib) monotherapy priming period (cycle 0; 21 days); an anti-PD-1 antibody (Dostarlimab ; TSR-042) will then be added from C1D1 every 21 days in combination for the first 4 cycles, and then every 42 days. Disease will be assessed every 2 cycles (6 weeks) from C3D1 by CT-scan (or MRI or bone scan, if relevant). Patients still under treatment after 1 year may have tumor evaluation spaced out every 3 cycles Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Dostarlimab Start Date: 2021-04-07 Last Updated: 2023-01-23 Number of Patients: 112 Recruitment Status: RECRUITING Condition: Urothelial Bladder Cancer
NCTID: NCT00932451
Title: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Study Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066. Sponsor: Pfizer Intervention: PF-02341066 Start Date: 2010-01 Last Updated: 2017-01-13 Number of Patients: 1069 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02217956
Title: Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma Study Summary: HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few studies have been published on the use of HCIP in peritoneal carcinosis from ovarian background but most of them were non-randomized phase II studies on a small population using different type of drugs and dosage. before this heterogeneity it seems necessary to standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian background Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Cisplatin Start Date: 2011-06 Last Updated: 2016-01-26 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Ovarian Adenocarcinoma
NCTID: NCT00936156
Title: Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years Study Summary: Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Chemotherapy (carboplatin, etoposide, thiotepa) Start Date: 2009-01 Last Updated: 2020-06-29 Number of Patients: 68 Recruitment Status: COMPLETED Condition: Metastatic, Cerebral Primitive Neuroectodermal Tumors
NCTID: NCT01393756
Title: Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma Study Summary: The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment. Sponsor: The Lymphoma Academic Research Organisation Intervention: Lenalidomide and R-CHOP Start Date: 2010-12 Last Updated: 2021-07-26 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT03481556
Title: Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM Study Summary: This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab. Sponsor: Oncopeptides AB Intervention: Melphalan flufenamide (Melflufen) Start Date: 2018-04-12 Last Updated: 2022-12-19 Number of Patients: 56 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT01436656
Title: A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma Study Summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D. Sponsor: Pfizer Intervention: LGX818 Start Date: 2011-09-05 Last Updated: 2023-08-16 Number of Patients: 93 Recruitment Status: COMPLETED Condition: Melanoma and Metastatic Colorectal Cancer
NCTID: NCT00180856
Title: Radiofrequency Ablation of Lung Tumors Study Summary: Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Radiofrequency ablation Start Date: 2002-01 Last Updated: 2005-09-16 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT04300556
Title: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types Study Summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer <math display="block">OC</math>, endometrial cancer <math display="block">EC</math>, non-small cell lung carcinoma <math display="block">NSCLC</math>, triple-negative breast cancer <math display="block">TNBC</math>), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A <math display="block">OC and EC participants</math> and Part B <math display="block">EC only</math>): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202). Sponsor: Eisai Inc. Intervention: Farletuzumab ecteribulin Start Date: 2020-08-06 Last Updated: 2023-11-01 Number of Patients: 142 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT02178956
Title: A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer Study Summary: The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy. Sponsor: Sumitomo Pharma America, Inc. Intervention: BBI608 Start Date: 2014-10 Last Updated: 2023-11-15 Number of Patients: 714 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT02155647
Title: Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) Study Summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2014-07-03 Last Updated: 2023-06-05 Number of Patients: 204 Recruitment Status: COMPLETED Condition: Carcinoma, Merkel Cell
NCTID: NCT04300647
Title: A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer Study Summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent). Sponsor: Hoffmann-La Roche Intervention: Tiragolumab Start Date: 2020-06-30 Last Updated: 2023-11-18 Number of Patients: 172 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cervical Cancer
NCTID: NCT05201547
Title: Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line Study Summary: Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer. Sponsor: ARCAGY/ GINECO GROUP Intervention: Carboplatin-Paclitaxel Start Date: 2022-04-15 Last Updated: 2023-07-27 Number of Patients: 260 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT03820986
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) Study Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-03-12 Last Updated: 2023-04-25 Number of Patients: 674 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Malignant Melanoma
NCTID: NCT01460186
Title: Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer Study Summary: This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer. 1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study. Patients will be treated and followed according to the standards of their treating center. They will be followed during at least 5 years every 6 months for 3 years then every year. Sponsor: Centre Leon Berard Intervention: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer) Start Date: 2011-12 Last Updated: 2019-01-15 Number of Patients: 1000 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02880943
Title: Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) Study Summary: This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases. Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie Intervention: XOFIGO Start Date: 2016-10 Last Updated: 2016-11-08 Number of Patients: 42 Recruitment Status: UNKNOWN Condition: Clear-cell Metastatic Renal Cell Carcinoma
NCTID: NCT00035243
Title: EPO906 Therapy in Patients With Advanced Kidney Cancer Study Summary: This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer. Sponsor: Novartis Pharmaceuticals Intervention: epothilone b Start Date: 2002-04 Last Updated: 2012-04-17 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Kidney Neoplasms
NCTID: NCT02197637
Title: Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma Study Summary: The purpose of this study is to determine whether oral vinorelbine is effective in the treatment of children with progressive or recurrent unresectable low grade glioma. Sponsor: Centre Oscar Lambret Intervention: ORAL VINORELBINE Start Date: 2014-05 Last Updated: 2020-11-18 Number of Patients: 39 Recruitment Status: COMPLETED Condition: Low-Grade Glioma
NCTID: NCT02352337
Title: First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem Study Summary: The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy. Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin. These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years. FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn’t induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment. The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: FOLFIRINOX Start Date: 2014-12-23 Last Updated: 2022-08-22 Number of Patients: 276 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Cancer
NCTID: NCT05444712
Title: Transplantation After Complete Response In Patients With T-cell Lymphoma Study Summary: Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL. The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction. Sponsor: Hospices Civils de Lyon Intervention: Chemotherapy + follow up Start Date: 2022-08-01 Last Updated: 2023-09-28 Number of Patients: 204 Recruitment Status: RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT02978755
Title: First In Human Safety, Pharmacokinetics and Anti-tumoral Activity of GM102 in Gynecological Cancers Study Summary: First in Human study, assessing the safety profile, the pharmacokinetics and preliminary antitumor activity of GM102, a new compound (a monoclonal antibody), in patients with previously treated gynecological cancers bearing the AMHRII (anti-mullerian Hormone Receptor II) receptor. The primary objective of the study is to determine the GM102 recommended dose. Sponsor: GamaMabs Pharma Intervention: GM102 Start Date: 2016-06 Last Updated: 2022-04-06 Number of Patients: 78 Recruitment Status: COMPLETED Condition: Neoplasm, Gynecologic
NCTID: NCT04940325
Title: Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer Study Summary: This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more than three previous standard therapies. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated. A total of 100 participants are planned to be included in the study. Participants will receive, every three weeks, a dose of DS-1062a equivalent to 6 mg/kg of body weight until progression or until unacceptable toxicity. Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: DS-1062a Start Date: 2021-05-12 Last Updated: 2021-06-25 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Metastatic Lung Cancer
NCTID: NCT01353625
Title: Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies. Study Summary: The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients. Sponsor: Celgene Intervention: CC-115 Start Date: 2011-04-25 Last Updated: 2021-10-05 Number of Patients: 118 Recruitment Status: COMPLETED Condition: Glioblastoma Multiforme
NCTID: NCT02994225
Title: Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity Study Summary: The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain. The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Indocyanine Green Start Date: 2017-03-10 Last Updated: 2022-05-16 Number of Patients: 120 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04597125
Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. Sponsor: Bayer Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) Start Date: 2020-11-09 Last Updated: 2023-11-14 Number of Patients: 696 Recruitment Status: RECRUITING Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
NCTID: NCT02517125
Title: Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors Study Summary: Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O’Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci. The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The objective of our study is therefore to study the feasibility of this transoral robotic surgery for head and neck cancers, using the da Vinci Xi. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Transoral robotic-assisted surgery with Da Vinci Xi Start Date: 2015-04 Last Updated: 2023-01-25 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Cancer
NCTID: NCT03609112
Title: Neurocognitive Risks in Children With Solid Tumors Study Summary: The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors. Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors) Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: The WISC-IV Start Date: 2014-10-01 Last Updated: 2018-08-01 Number of Patients: 1000 Recruitment Status: UNKNOWN Condition: Solid Tumor in Children
NCTID: NCT04932525
Title: Gustave Roussy Cancer Profiling Study Summary: The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Biopsy Start Date: 2021-05-10 Last Updated: 2023-05-17 Number of Patients: 10000 Recruitment Status: RECRUITING Condition: Solid Tumor, Unspecified, Adult
NCTID: NCT01111825
Title: Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer Study Summary: This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease. Sponsor: Puma Biotechnology, Inc. Intervention: Temsirolimus Start Date: 2010-04 Last Updated: 2018-09-26 Number of Patients: 99 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02364492
Title: A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse Study Summary: The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks. Sponsor: Institut Pasteur Intervention: MAG-TN3 + AS15 Start Date: 2015-02 Last Updated: 2022-04-01 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT02666612
Title: Measurement and Characterization of Circulating Endothelial Cells or Circulating Tumor Cells or Circulating DNA in Adult Patients With Metastatic Cancer Study Summary: Monitoring of circulating endothelial cells (CEC and mature cells called progenitors called CEP) or circulating tumor cells (CTC) in adult patients with metastatic cancer, possibly treated with targeted therapy. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Blood samples Start Date: 2008-08 Last Updated: 2017-01-26 Number of Patients: 2240 Recruitment Status: UNKNOWN Condition: Metastatic Cancer
NCTID: NCT00090025
Title: XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Study Summary: The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors. Sponsor: Helsinn Healthcare SA Intervention: becatecarin Start Date: 2004-09 Last Updated: 2009-01-14 Number of Patients: 248 Recruitment Status: TERMINATED Condition: Biliary Tract Cancer
NCTID: NCT05329792
Title: L19IL2/L19TNF in Skin Cancer Patients Study Summary: Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention. Sponsor: Philogen S.p.A. Intervention: L19IL2/L19TNF Start Date: 2023-03-09 Last Updated: 2023-10-06 Number of Patients: 70 Recruitment Status: RECRUITING Condition: BCC - Basal Cell Carcinoma
NCTID: NCT02818725
Title: I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations Study Summary: OBJECTIVES OF THE TRIAL Primary objective Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations. Secondary objectives * To assess toxicity * To assess response rate * To assess overall survival * To assess time to progression * To study the correlation between response rate, time to progression, overall survival and biological parameters Sponsor: UNICANCER Intervention: Chemotherapy Start Date: 2010-06 Last Updated: 2021-03-09 Number of Patients: 133 Recruitment Status: COMPLETED Condition: Infiltrating Urothelial Carcinoma
NCTID: NCT01566019
Title: Molecular Screening for Cancer Treatment Optimization Study Summary: The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line. The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Tumoral biopsy Start Date: 2011-10-28 Last Updated: 2020-02-17 Number of Patients: 2150 Recruitment Status: UNKNOWN Condition: Metastatic Solid Tumors (Any Localization)
NCTID: NCT02992912
Title: Atezolizumab With Stereotactic Ablative Radiotherapy in Patients With Metastatic Tumours Study Summary: Although it is usually described as an immunosuppressive modality and not thought of as immunotherapy, there are new preclinical evidences suggesting that high-dose ionizing irradiation (IR) results in direct tumour cell death and augments tumour-specific immunity, which enhances tumour control both locally and distantly. Importantly, IR effects exceed the classical cytocidal properties by also causing phenotypic changes in the fraction of surviving cells, markedly enhancing their susceptibility to T cell-mediated elimination. However, not all IR-induced modifications of the tumour and its microenvironment favor immune rejection. The tumour microenvironment is populated by various types of inhibitory immune cells including Tregs, alternatively activated macrophages, and myeloid-derived suppression cells (MDSCs), which suppress T cell activation and promote tumour outgrowth. Chiang et al. showed the accumulation of pro-tumourigenic M2 macrophages in areas of hypoxia present in irradiated tumours. IR then may also induced responses that are inadequate to maintain antitumuor immunity. Close interaction between IR, T cells, and the PD-L1/PD-1 axis exsit and provide a basis for the rational design of combination therapy with immune modulators and radiotherapy. Deng et al. demonstrate that PD-L1 was upregulated in the tumour microenvironment after IR. Moreover, administration of anti-PD-L1 enhanced the efficacy of IR through a cytotoxic T cell-dependent mechanism. Concomitant with IR-mediated tumour regression, IR and anti-PD-L1 synergistically reduced the local accumulation of tumour-infiltrating MDSCs, which suppress T cells and alter the tumour immune microenvironment. Finally, activation of cytotoxic T cells with combination therapy mediated the reduction of MDSCs in tumours through the cytotoxic actions of TNF. Sagiv-Barfi et al, also demonstrated in 5 patients receiving atezolizumab and radiation therapy, at least stabilization of systemic progression in all patients and a RECIST partial response at systemic sites in 1 patient. Transient, grade 1-2 inflammatory adverse events (fevers, flu-like symptoms) occurred with no serious immune-related toxicities. Abscopal out-field effects of irradiation has also been described in addition to a reduction in circulating MDSCs in a melanoma patient treated with the anti CTLA-4 ipilimumab and radiotherapy. Lastly, recent evidence demonstrates that loco-regional curative treatment with stereotactic ablative radiotherapy (SABR) is a good alternative as compared with conventional 3D RT for patients with solid tumour, with durable remissions and a low toxicity profile. Many non-randomised studies have shown that SBRT for oligometastases is safe and effective, with local control rates of about 80%. Importantly, these studies also suggest that the natural history of the disease is changing, with 2-5 year progression-free survival of about 20%. For colorectal, non-small cell, and renal cell cancers, 1-year metastasis control rates ranged from 67 to 91%. Moreover, abscopal reponses in the setting of immune checkpoints inhibitors and radiotherapy combinations have been made in the setting of metastatic disease event in patients with extensive tumor burden. The goal of SABR is to deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Interestingly, the dose and fractionation employed modulate RT ability to synergize with immunotherapy. Vanpouille-Box et al, showed that immune response genes were differentially expressed in irradiated tumours by 8Gyx3 but not 20Gyx1. This highlight the interest of hypofractionated SABR acting as a “in situ tumour vaccine”. As hypofractionated SABR may, in addition to its good local control, increase the effectiveness of anti PD-L1, investigators aimed to investigate the efficacy and the tolerability of the combination of anti-PD-L1 antibody with SABR. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Anti-PD-L1 antibody atezolizumab Start Date: 2016-10-17 Last Updated: 2020-02-19 Number of Patients: 187 Recruitment Status: UNKNOWN Condition: Patients With Metastatic Tumours (Colorectal Cancer, Non-small Lung Cancer, Renal Cell Carcinoma or Sarcoma )
NCTID: NCT02410512
Title: A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors Study Summary: This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage. Sponsor: Genentech, Inc. Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody Start Date: 2015-04-24 Last Updated: 2022-04-01 Number of Patients: 610 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04447755
Title: A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) Study Summary: The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-07-30 Last Updated: 2023-10-04 Number of Patients: 127 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed or Refractory Solid Tumors
NCTID: NCT04209855
Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Study Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab Soravtansine Start Date: 2019-12-31 Last Updated: 2023-03-06 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Epithelial Ovarian Cancer
NCTID: NCT04513925
Title: A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Study Summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-08-24 Last Updated: 2023-11-03 Number of Patients: 829 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer (NSCLC)
NCTID: NCT03016312
Title: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen Study Summary: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-10 Last Updated: 2023-02-17 Number of Patients: 772 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms, Castration-Resistant
NCTID: NCT00003212
Title: Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: doxorubicin hydrochloride Start Date: 1998-01 Last Updated: 2012-01-20 Number of Patients: 780 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT03248492
Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Study Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2017-08-25 Last Updated: 2023-11-15 Number of Patients: 253 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03068455
Title: An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma Study Summary: The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma Sponsor: Bristol-Myers Squibb Intervention: nivolumab Start Date: 2017-04-11 Last Updated: 2021-09-20 Number of Patients: 1844 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT04789655
Title: Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia Study Summary: This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D. Sponsor: Celgene Intervention: CC-96191 Start Date: 2021-06-16 Last Updated: 2023-09-28 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Leukemia, Myeloid
NCTID: NCT02856425
Title: Trial Of Pembrolizumab And Nintedanib Study Summary: Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy for the benefit of the patients. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nintedanib Start Date: 2016-11-10 Last Updated: 2023-04-25 Number of Patients: 221 Recruitment Status: RECRUITING Condition: Patients With Any Advanced Solid Tumors
NCTID: NCT03892525
Title: Study of Intratumoral Selicrelumab With Atezolizumab in Patients With Refractory or Relapsed B Cell Lymphoma Study Summary: This is a multicenter, open, dose escalation phase Ib trial of intratumoral agonistic anti-CD40 Ab (Selicrelumab intratumoral every 3 weeks for 3 cycles) in combination with anti-PDL1 Ab (Atezolizumab 1200mg intravenous every 3 weeks) in patients with refractory or relapsed B cell lymphoma Sponsor: The Lymphoma Academic Research Organisation Intervention: Selicrelumab Start Date: 2019-07-04 Last Updated: 2021-07-26 Number of Patients: 4 Recruitment Status: TERMINATED Condition: Recurrent B-Cell Non-Hodgkin Lymphoma
NCTID: NCT05157555
Title: Quality of Life in Patients After Pharyngolaryngectomy Study Summary: Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares. Sponsor: Université de Reims Champagne-Ardenne Intervention: Data collection Start Date: 2022-02-10 Last Updated: 2022-03-25 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Laryngectomy; Status
NCTID: NCT05269355
Title: A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) Study Summary: This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy. Sponsor: PTC Therapeutics Intervention: Unesbulin Start Date: 2022-05-23 Last Updated: 2023-11-24 Number of Patients: 345 Recruitment Status: RECRUITING Condition: Leiomyosarcoma
NCTID: NCT01267955
Title: Vismodegib in Treating Patients With Advanced Chondrosarcomas Study Summary: This phase II trial studies how well vismodegib works in treating patients with chondrosarcomas that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sponsor: National Cancer Institute (NCI) Intervention: Laboratory Biomarker Analysis Start Date: 2010-12-21 Last Updated: 2023-11-24 Number of Patients: 45 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Clear Cell Chondrosarcoma
NCTID: NCT02666625
Title: Iatrogenic Effects of Treatment for Childhood Cancer Constitution of a Biological Samples Bank Study Summary: The constitution of a biological samples bank, attached to epidemiological studies Cohort F-CCSS on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. The main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. These conditions can be very incapacitating and in some cases, fatal. Their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. The overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: saliva samples Start Date: 2010-12 Last Updated: 2016-06-09 Number of Patients: 6000 Recruitment Status: UNKNOWN Condition: Paediatric Malignancies
NCTID: NCT00932412
Title: The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial) Study Summary: This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation. We will compare efficacy and toxicity among the two arms. Sponsor: Hospices Civils de Lyon Intervention: CLARA Start Date: 2009-03 Last Updated: 2016-09-21 Number of Patients: 735 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT01296555
Title: A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin’s Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer Study Summary: This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer. Sponsor: Genentech, Inc. Intervention: Fulvestrant Start Date: 2011-03-16 Last Updated: 2021-09-05 Number of Patients: 686 Recruitment Status: COMPLETED Condition: Solid Cancers
NCTID: NCT02662725
Title: Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases Study Summary: This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker. Sponsor: University Hospital, Lille Intervention: IPILIMUMAB Start Date: 2012-09 Last Updated: 2016-01-25 Number of Patients: 73 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT00516412
Title: Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma Study Summary: RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma. Sponsor: Swiss Group for Clinical Cancer Research Intervention: everolimus Start Date: 2007-08 Last Updated: 2015-09-29 Number of Patients: 35 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT03682055
Title: Phase 1/2a Study of VK-2019 in Patients With Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma (NPC) Study Summary: VK-2019-001 is a 1/2a trial of the oral EBNA-1 targeting agent VK-2019 in patients with EBV-positive recurrent or metastatic NPC to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D), as well as to evaluate the PK profile of VK-2019. Sponsor: Cullinan Oncology, LLC Intervention: VK-2019 Start Date: 2019-04-04 Last Updated: 2023-08-15 Number of Patients: 14 Recruitment Status: TERMINATED Condition: Nasopharyngeal Carcinoma
NCTID: NCT01578655
Title: Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer Study Summary: This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms. Sponsor: Achieve Life Sciences Intervention: cabazitaxel Start Date: 2012-08 Last Updated: 2016-10-12 Number of Patients: 630 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04953312
Title: Calprotectin, a Biomarker of COVID-19 Severity (CALPRO) Study Summary: The purpose of this study is to provide new insights into the pathophysiology of emergency hematopoiesis detected in severe COVID-19 patients. The investigators aim to explore the ability of calprotectin to induce an immunosuppressive myeloid program at the hematopoietic stem and progenitor cell (HSPC) level, and to identify the receptor(s) involved in this effect. Since patients with a hematological malignancy demonstrate a very high propensity to develop a severe COVID-19, the investigators will explore how HSPCs collected from patients with a myeloid malignancy respond to calprotectin. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: Blood samples Start Date: 2023-01 Last Updated: 2022-10-12 Number of Patients: 55 Recruitment Status: NOT_YET_RECRUITING Condition: Severe/Moderate Coronavirus
NCTID: NCT02574455
Title: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) Study Summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline. Sponsor: Gilead Sciences Intervention: Sacituzumab govitecan Start Date: 2017-11-07 Last Updated: 2022-06-15 Number of Patients: 529 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00144755
Title: R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma Study Summary: This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 g/dl, compared to classical symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large B-cell lymphoma. Sponsor: Lymphoma Study Association Intervention: Darbepoetin alfa Start Date: 2003-12 Last Updated: 2015-09-02 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Diffuse Large Cell Lymphoma
NCTID: NCT01907607
Title: Efficacy and Safety of PD-0332991 in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib Study Summary: The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib is frequently short, and after failure with both imatinib and sunitinib, treatment remains controversial. Previous studies on GISTs have linked 9p21 alterations to tumor progression (El-Rifai et al. 2000; Kim et al., 2000; Schneider-Stock et al., 2003; Schneider-Stock et al., 2005; Romeo et al. 2009; Haller et al., 2008) but the driver gene was not positively identified (CDKN2A, CDKN2B, or MTAP) (Astolfi et al., 2010; Belinsky et al., 2009; Perrone et al., 2005; Assamaki et al. 2007; Huang et al., 2009). A recent study has shown that homozygous 9p21 deletions target CDKN2A and more specifically p16INK4a 4. Most of the CINSARC genes are known to be under the transcriptional control of E2F. RB1 sequesters E2F, which is released from the complex upon RB1 phosphorylation by CDK4. CDK4 is, in turn, inhibited by p16INK4a. Hence, we hypothesize that alteration of the restriction point via deletion of p16INK4a (and more rarely of RB1: 20% of cases) gene in GISTs is likely to be a causative event that leads to the overexpression of CINSARC genes, which in turn induce chromosome instability and ultimately metastasis. Low p16INK4a expression was associated with response to PD-0332991 in several in vitro tumor model(Konecny et al. 2011; Katsumi et al. 2011; Finn et al. 2009). Considering our molecular data, we believed that PD-0332991 warrants clinical investigation in advanced gastrointestinal stromal tumors with alteration of p16INK4a. This alteration is detectable by comparative genomic hybridization which is a technique highly manageable in the context of routine clinical care and clinical trial. Main objective was to assess the antitumor activity of PD-0332991 in terms of non-progression at 16 weeks (after centralized review) in patients with documented disease progression while on therapy with imatinib and sunitinib for unresectable and/or metastatic GIST. Sponsor: Institut Bergonié Intervention: PD 0332991 Start Date: 2014-02 Last Updated: 2021-01-20 Number of Patients: 29 Recruitment Status: COMPLETED Condition: Advanced Gastrointestinal Stromal Tumors
NCTID: NCT00217607
Title: Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery. Sponsor: UNICANCER Intervention: paclitaxel Start Date: 2005-02 Last Updated: 2016-08-30 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT03445533
Title: A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma Study Summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma Sponsor: Idera Pharmaceuticals, Inc. Intervention: Ipilimumab Start Date: 2018-05-30 Last Updated: 2022-11-08 Number of Patients: 481 Recruitment Status: TERMINATED Condition: Metastatic Melanoma
NCTID: NCT04254107
Title: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer Study Summary: This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas. The study will have four parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL). Sponsor: Seagen Inc. Intervention: SEA-TGT Start Date: 2020-05-29 Last Updated: 2023-11-09 Number of Patients: 132 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT03643133
Title: Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients Study Summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response). Sponsor: UNICANCER Intervention: Mifamurtide Start Date: 2018-10-23 Last Updated: 2022-12-09 Number of Patients: 126 Recruitment Status: RECRUITING Condition: Osteosarcoma
NCTID: NCT00407433
Title: Clinical Studies of Gemcitabine-Oxaliplatin Study Summary: These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®) Start Date: NA Last Updated: 2009-08-07 Number of Patients: 156 Recruitment Status: COMPLETED Condition: Medulloblastoma
NCTID: NCT03990233
Title: A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours Study Summary: This trial will be a two steps Phase I clinical study in patients with advanced solid tumors with an escalating phase (Step 1) followed by an expansion phase (Step 2) of BI 765063, a monoclonal antibody (mAb) antagonist to signal regulatory protein alpha (SIRPα) receptor, a myeloid checkpoint inhibitor administered as single agent, and in combination with BI 754091, a mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor. Sponsor: OSE Immunotherapeutics Intervention: BI 765063 Start Date: 2019-04-16 Last Updated: 2023-09-13 Number of Patients: 116 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT04702737
Title: A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer Study Summary: To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). Sponsor: Amgen Intervention: Tarlatamab Start Date: 2021-06-10 Last Updated: 2023-10-13 Number of Patients: 41 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neuroendocrine Prostate Cancer
NCTID: NCT03600883
Title: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) Study Summary: Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors. Sponsor: Amgen Intervention: sotorasib Start Date: 2018-08-27 Last Updated: 2023-10-25 Number of Patients: 713 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: KRAS p.G12C Mutant Advanced Solid Tumors
NCTID: NCT01368107
Title: Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients Study Summary: The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients. The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count. This study is a phase II, randomised, double-blind, placebo-controlled, single-centre. 24 patients will be included in the study. Sponsor: Centre Leon Berard Intervention: placebo Start Date: 2011-06 Last Updated: 2015-02-09 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04625907
Title: FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma Study Summary: FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS) Sponsor: University of Birmingham Intervention: Irinotecan Start Date: 2020-09-17 Last Updated: 2023-05-10 Number of Patients: 1672 Recruitment Status: RECRUITING Condition: Rhabdomyosarcoma
NCTID: NCT00263783
Title: Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors Study Summary: To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors. Sponsor: MedImmune LLC Intervention: MEDI-522 Start Date: 2001-03 Last Updated: 2009-01-29 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT02174107
Title: Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases. Study Summary: The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty. Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly, This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center : * Arm A: Percutaneous vertebroplasty * Arm B: External radiotherapy This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm). Sponsor: Centre Leon Berard Intervention: External radiotherapy Start Date: 2015-04 Last Updated: 2017-01-10 Number of Patients: 7 Recruitment Status: TERMINATED Condition: Spine Metastases
NCTID: NCT00643565
Title: A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma. Study Summary: This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years. Sponsor: Hoffmann-La Roche Intervention: Standard chemotherapy Start Date: 2008-07-29 Last Updated: 2019-10-22 Number of Patients: 154 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02243605
Title: Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma Study Summary: This phase II trial studies how well cabozantinib s-malate works in treating patients with osteosarcoma or Ewing sarcoma that has grown or returned (come back) after a period of improvement. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may also prevent the growth of new blood vessels that tumors need to grow. Sponsor: National Cancer Institute (NCI) Intervention: Cabozantinib S-malate Start Date: 2014-12-19 Last Updated: 2023-10-31 Number of Patients: 90 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Ewing Sarcoma
NCTID: NCT00127049
Title: Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors Study Summary: This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: gemcitabine, ifosfamide, cisplatin, G-CSF Start Date: 2004-12 Last Updated: 2006-09-08 Number of Patients: 37 Recruitment Status: UNKNOWN Condition: Germ Cell Tumor
NCTID: NCT05631249
Title: Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C Study Summary: This study aims to provide a comprehensive understanding of sotorasib’s mechanisms of action and resistance in NSCLC patients. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Sotorasib 120Mg Tab Start Date: 2022-12-13 Last Updated: 2022-12-19 Number of Patients: 40 Recruitment Status: RECRUITING Condition: KRAS P.G12C
NCTID: NCT00769405
Title: Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer. PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer. Sponsor: UNICANCER Intervention: fluorouracil Start Date: 2008-02 Last Updated: 2016-08-30 Number of Patients: 264 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02233049
Title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication Study Summary: Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their clinical presentation is stereotyped with a short clinical history and a unique MRI appearance that was usually considered as sufficient to establish the diagnosis. The prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave 2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of paediatric oncology; despite numerous collaborative studies performed, patients’ survival has not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic factor. There is currently no validated treatment except radiotherapy. Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger, 2011), without knowing whether the target was present in the tumour. A critical review of the paradigms of these trials tells us that there are long term survivors in these studies that is to say patients who may have benefited from the tested therapy, but they are few. So far, the new therapies that have been tried were evaluated one after the other in search of a treatment that would be effective for all patients, measuring the treatment effect on median survival. They were all rejected as ineffective. However the investigators can challenge the endpoint to evaluate efficacy in these trials as the existence of long term survivors (> 18 months, for example) and their number should not been ignored, especially if targeted therapies are considered. The investigators propose a paradigm shift in the choice of treatment; the issue raised would be to give to each patient the treatment associated with the highest likelihood of efficacy based on the specific biological tumour profile. The development of targeted therapies for malignant gliomas infiltrating the brainstem has been hampered by the absence of biological data. It is therefore crucial to better understand the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or radiologically unusual forms. Until recently, there has been no systematic genetic study at diagnosis to date and the few available data were confounded by the inclusion of autopsies or clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008; Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012). French teams gathered in the French Society of Paediatric Oncology and the European consortium “Innovative Therapies in Children with Cancer (ITCC)” decided a few years ago to perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct sequencing of candidate genes studies. In this study, the majority of patients will receive a treatment assumed to specifically target a biological abnormality identified on the biopsy. More importantly, patients will not receive a drug for which the identified target is absent. In this first step of the protocol, the patients will thus be allocated to one of the three treatment groups as follows: * If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive erlotinib or dasatinib allocated by randomization (R1 randomisation). * If the tumor shows loss of PTEN expression without EGFR overexpression, patients may receive everolimus or dasatinib allocated by randomisation (R2 randomisation). * If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation). * If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare situation in our experience), patients will receive dasatinib (no randomisation). * If the biopsy assessment is not contributive, the treatment will be allocated by randomisation between erlotinib, everolimus and dasatinib (R3 randomisation). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Erlotinib Start Date: 2014-10 Last Updated: 2018-07-23 Number of Patients: 250 Recruitment Status: UNKNOWN Condition: Diffuse Intrinsic Pontine Glioma
NCTID: NCT01953926
Title: Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations Study Summary: This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. Sponsor: Puma Biotechnology, Inc. Intervention: Neratinib Start Date: 2013-09-30 Last Updated: 2023-01-19 Number of Patients: 582 Recruitment Status: COMPLETED Condition: Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
NCTID: NCT03841305
Title: Simultaneous Portal and Hepatic Vein Versus Portal Vein Embolizations for Hypertrophy of the Future Liver Remnant Study Summary: The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable. Sponsor: University Hospital, Montpellier Intervention: Liver preparation before major hepatectomy Start Date: 2019-04-29 Last Updated: 2023-05-03 Number of Patients: 64 Recruitment Status: RECRUITING Condition: Liver Metastasis Colon Cancer
NCTID: NCT01477749
Title: Sipuleucel-T Manufacturing Demonstration Study Study Summary: To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility. Sponsor: Dendreon Intervention: sipuleucel-T Start Date: 2012-06 Last Updated: 2015-12-09 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Cancer of Prostate
NCTID: NCT02132949
Title: A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer Study Summary: This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment. Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2014-07-14 Last Updated: 2021-09-17 Number of Patients: 401 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00003652
Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer. Sponsor: UNICANCER Intervention: cisplatin Start Date: 1999-01-04 Last Updated: 2021-02-17 Number of Patients: 350 Recruitment Status: COMPLETED Condition: Anal Cancer
NCTID: NCT01669252
Title: Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer Study Summary: This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer. Sponsor: SOLTI Breast Cancer Research Group Intervention: Eribulin Start Date: 2012-08 Last Updated: 2017-11-06 Number of Patients: 163 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02108652
Title: A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2) Study Summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-05-31 Last Updated: 2023-03-08 Number of Patients: 310 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT00448305
Title: EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients Study Summary: The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer). Sponsor: MediGene Intervention: EndoTAG-1 + paclitaxel Start Date: 2007-01 Last Updated: 2012-01-05 Number of Patients: 143 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05439005
Title: Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study. Study Summary: This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group. Sponsor: Institut Curie Intervention: Dexmedetomidine Start Date: 2022-12-07 Last Updated: 2023-10-12 Number of Patients: 158 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03768505
Title: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL) Study Summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy Sponsor: MEI Pharma, Inc. Intervention: Zandelisib (ME-401) Start Date: 2019-06-25 Last Updated: 2023-05-09 Number of Patients: 169 Recruitment Status: TERMINATED Condition: Follicular Lymphoma (FL)
NCTID: NCT03404726
Title: A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies Study Summary: The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement). Sponsor: Bayer Intervention: BAY2402234 Start Date: 2018-03-29 Last Updated: 2022-01-11 Number of Patients: 40 Recruitment Status: TERMINATED Condition: Leukemia
NCTID: NCT00041249
Title: Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: brostallicin Start Date: 2002-05 Last Updated: 2012-07-18 Number of Patients: 64 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumor
NCTID: NCT02260505
Title: Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) Study Summary: This is a 2 arms study concerning patients with primary GIST who followed an Imatinib adjuvant treatment for 3 years after surgery and who have a high risk of recurrence. In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to determine if the continuation of this treatment is efficient for disease control, in terms of Disease Free Survival improvement. In the second arm, patients will discontinue the Imatinib treatment, as standard practice. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease. Sponsor: Centre Leon Berard Intervention: Imatinib maintenance Start Date: 2014-12-24 Last Updated: 2023-08-30 Number of Patients: 134 Recruitment Status: RECRUITING Condition: Gastrointestinal Stromal Tumors
NCTID: NCT05544552
Title: Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations Study Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors. Sponsor: Tyra Biosciences, Inc Intervention: TYRA-300 Start Date: 2022-11-22 Last Updated: 2023-10-26 Number of Patients: 310 Recruitment Status: RECRUITING Condition: Locally Advanced Urothelial Carcinoma
NCTID: NCT02049905
Title: Phase 3 Study to Treat Patients With Soft Tissue Sarcomas Study Summary: The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas. Sponsor: ImmunityBio, Inc. Intervention: Aldoxorubicin Start Date: 2014-01 Last Updated: 2022-03-29 Number of Patients: 433 Recruitment Status: COMPLETED Condition: Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma
NCTID: NCT04189445
Title: Futibatinib in Patients With Specific FGFR Aberrations Study Summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma <math display="block">iCCA</math>); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements. Sponsor: Taiho Oncology, Inc. Intervention: Futibatinib Start Date: 2020-08-24 Last Updated: 2023-06-06 Number of Patients: 115 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced or Metastatic Solid Tumor
NCTID: NCT01949545
Title: Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment Study Summary: The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2013-10 Last Updated: 2017-05-02 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT04410445
Title: Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence Study Summary: The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence. Sponsor: Nektar Therapeutics Intervention: Bempegaldesleukin Start Date: 2020-07-27 Last Updated: 2023-04-21 Number of Patients: 765 Recruitment Status: TERMINATED Condition: Melanoma
NCTID: NCT03235245
Title: Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib Study Summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab + Ipilimumab Start Date: 2018-10-30 Last Updated: 2023-11-03 Number of Patients: 271 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Unresectable Stage III Melanoma
NCTID: NCT02323568
Title: Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs. Study Summary: This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients. From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients. In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population. Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project. Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window Sponsor: Centre Francois Baclesse Intervention: Gynecological consultation Start Date: 2014-12 Last Updated: 2017-02-10 Number of Patients: 179 Recruitment Status: COMPLETED Condition: Epithelial Ovarian Cancer
NCTID: NCT03324282
Title: First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma Study Summary: This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started). Sponsor: University Hospital, Bordeaux Intervention: Avelumab Start Date: 2018-02-23 Last Updated: 2022-05-03 Number of Patients: 65 Recruitment Status: TERMINATED Condition: Bladder Carcinoma
NCTID: NCT05317416
Title: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant Study Summary: The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years Sponsor: Pfizer Intervention: Elranatamab Start Date: 2022-03-25 Last Updated: 2023-11-28 Number of Patients: 760 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT04632316
Title: A Trial to Evaluate the Safety and Efficacy of oNKord® in Subjects With Acute Myeloid Leukemia Study Summary: WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation. Sponsor: Glycostem Therapeutics BV Intervention: Cyclophosphamide-Fludarabine (Cy/Flu) Start Date: 2020-12-08 Last Updated: 2022-06-21 Number of Patients: 33 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT01355445
Title: Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma Study Summary: This is an international open-label, randomized, multicenter phase II study of VIT and VI for the treatment of patients with recurrent or refractory rhabdomyosarcoma. The study will evaluate the safety and efficacy of these combinations in patients with recurrent or refractory rhabdomyosarcoma. Sponsor: Centre Oscar Lambret Intervention: Vincristine, Irinotecan Start Date: 2012-01 Last Updated: 2019-09-18 Number of Patients: 120 Recruitment Status: COMPLETED Condition: RHABDOMYOSARCOMA
NCTID: NCT00360945
Title: Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma Study Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma. Sponsor: Children’s Cancer and Leukaemia Group Intervention: cisplatin Start Date: 2004-04 Last Updated: 2013-09-17 Number of Patients: 87 Recruitment Status: UNKNOWN Condition: Brain and Central Nervous System Tumors
NCTID: NCT05914168
Title: Clinical Data Collection in Breast Tomosynthesis (COBRIS) Study Summary: The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment Sponsor: GE Healthcare Intervention: Breast Tomosynthesis Start Date: 2023-02-15 Last Updated: 2023-06-22 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT01706016
Title: Local Treatment by Thermic Destruction of Primitive Breast Cancer Study Summary: Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Thermic destruction of tissue by Laser using the Novilase device Start Date: 2012-10-09 Last Updated: 2018-03-29 Number of Patients: 16 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01661816
Title: Breast Cancer and Quality of Life Study Summary: The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life. Sponsor: Centre Oscar Lambret Intervention: interview Start Date: 2007-04 Last Updated: 2012-08-10 Number of Patients: 171 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02983045
Title: A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors Study Summary: In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3. Sponsor: Nektar Therapeutics Intervention: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab Start Date: 2016-12-19 Last Updated: 2023-03-13 Number of Patients: 557 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT00418327
Title: Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma Study Summary: The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Tarceva (Erlotinib Hydrochloride) Start Date: 2005-06 Last Updated: 2009-08-07 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Malignant Brain Tumor
NCTID: NCT01718327
Title: A Study of Sunitinib in Patients With Advanced Cholangiocarcinoma Study Summary: For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is considered as the reference treatment in first line chemotherapy. However, the outcomes of these patients remain limited and therefore more effective drugs are warranted. The context of the disease and current data on sunitinib suggest that sunitinib may have activity in patients with advanced non resectable cholangiocarcinoma. Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity of sunitinib in such a patient population. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: Sunitinib Start Date: 2011-09-01 Last Updated: 2017-01-31 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Unresectable and Advanced Cholangiocarcinoma
NCTID: NCT04199104
Title: A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010) Study Summary: This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-02-05 Last Updated: 2023-11-02 Number of Patients: 511 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT04619004
Title: HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer Study Summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen. Sponsor: Daiichi Sankyo, Inc. Intervention: Patritumab Deruxtecan (Fixed dose) Start Date: 2021-02-02 Last Updated: 2023-11-18 Number of Patients: 420 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer Metastatic
NCTID: NCT03308604
Title: AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy Study Summary: This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method. Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Polysiloxane Gd-Chelates based nanoparticles (AGuIX) Start Date: 2018-05-17 Last Updated: 2021-07-07 Number of Patients: 18 Recruitment Status: RECRUITING Condition: Gynecologic Cancer
NCTID: NCT04968106
Title: Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO) Study Summary: Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of retifanlimab (INCMGA00012) in association with neoadjuvant chemotherapy Sponsor: Institut Bergonié Intervention: Doxorubicin Start Date: 2022-12-07 Last Updated: 2023-03-03 Number of Patients: 66 Recruitment Status: RECRUITING Condition: Resectable Sarcoma
NCTID: NCT03313206
Title: Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma Study Summary: The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Pembrolizumab Start Date: 2018-05-28 Last Updated: 2023-05-19 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Head and Neck Mucosal Melanomas
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT05198804
Title: A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer Study Summary: This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib in subjects with platinum-resistant ovarian cancer. Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Intervention: ZN-c3 Start Date: 2022-01-27 Last Updated: 2023-06-18 Number of Patients: 138 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT04886804
Title: A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) Study Summary: The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called BI 1810631 the participants can tolerate. Once this dose is found, it will be used in the second study part to tests whether BI 1810631 can make tumours shrink. In this study, BI 1810631 is given to people for the first time. Participants take BI 1810631 as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants’ health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1810631. Sponsor: Boehringer Ingelheim Intervention: BI 1810631 Start Date: 2021-06-22 Last Updated: 2023-11-28 Number of Patients: 371 Recruitment Status: RECRUITING Condition: Neoplasm Metastasis
NCTID: NCT06045806
Title: A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Study Summary: The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). Sponsor: Bristol-Myers Squibb Intervention: idecabtagene vicleucel Start Date: 2023-10-16 Last Updated: 2023-11-07 Number of Patients: 618 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT03964727
Title: Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors Study Summary: The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors. Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2019-10-15 Last Updated: 2023-10-23 Number of Patients: 165 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Solid Tumor
NCTID: NCT04733027
Title: First-in-human Phase I to Evaluate PEP-010 as Single Agent and in Combination With Paclitaxel (CleverPeptide) Study Summary: This is an open-label, non-controlled, multicenter, dose escalation, first-in-human phase I clinical trial with an expansion phase designed to assess the safety, tolerability, PK and PD parameters, and preliminary antitumor activity of intravenous dosing of PEP-010 as single agent and in combination with paclitaxel. PEP-010 will be administered as single agent in patients with solid cancers who are not amenable to standard treatment, or in combination in patients who are eligible for the paclitaxel therapy. Sponsor: Institut Curie Intervention: Dose escalation, first-in-human phase I clinical trial with an Expansion phase Start Date: 2021-05-18 Last Updated: 2023-10-12 Number of Patients: 56 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Solid Tumor Cancer
NCTID: NCT02004106
Title: A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid Tumors Study Summary: This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to <math display="block">\</=</math> 6 milligrams <math display="block">mg</math>). Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants. Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months. Sponsor: Hoffmann-La Roche Intervention: RO6895882 Start Date: 2013-12-31 Last Updated: 2018-03-06 Number of Patients: 110 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04901806
Title: Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors Study Summary: This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors. Sponsor: Pyramid Biosciences Intervention: PBI-200 Start Date: 2021-07-20 Last Updated: 2023-05-11 Number of Patients: 74 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT00346645
Title: A Phase II Study of Velcade® in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to determine whether Bortezomib is effective in the treatment of patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen for advanced disease. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Bortezomid (VELCADE®) Start Date: 2006-06 Last Updated: 2013-02-06 Number of Patients: 46 Recruitment Status: TERMINATED Condition: STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER
NCTID: NCT02379845
Title: NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Randomized Patients in Two Arms With Soft Tissue Sarcoma of the Extremity and Trunk Wall Study Summary: RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor. PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients. Sponsor: Nanobiotix Intervention: NBTXR3 Start Date: 2015-03-03 Last Updated: 2021-04-06 Number of Patients: 180 Recruitment Status: COMPLETED Condition: Adult Soft Tissue Sarcoma
NCTID: NCT05060016
Title: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) Study Summary: The main aim of this study is to: * evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 <math display="block">RECIST 1.1</math> by investigator) of 2 dose levels of tarlatamab for Part 1 only * evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2 * evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3 Sponsor: Amgen Intervention: Tarlatamab Start Date: 2021-12-01 Last Updated: 2023-10-18 Number of Patients: 222 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Small Cell Lung Cancer
NCTID: NCT01310816
Title: A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma Study Summary: IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma. Sponsor: Infinity Pharmaceuticals, Inc. Intervention: IPI-926 Start Date: 2011-02 Last Updated: 2013-12-05 Number of Patients: 105 Recruitment Status: COMPLETED Condition: Conventional Chondrosarcoma
NCTID: NCT04807816
Title: Targeting ATR in Soft-tissue Sarcomas Study Summary: Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine Sponsor: Institut Bergonié Intervention: Association of berzosertib with gemcitabine Start Date: 2022-02-09 Last Updated: 2023-09-28 Number of Patients: 72 Recruitment Status: RECRUITING Condition: Leiomyosarcoma, Adult
NCTID: NCT01837745
Title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients? Study Summary: Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group). The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx) Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: rhTSH stimulation Start Date: 2013-05-13 Last Updated: 2023-05-17 Number of Patients: 776 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Low Risk Differentiated Thyroid Cancer
NCTID: NCT05029882
Title: Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 460 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. In the dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2i) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2ii), squamous NSCLC (Part 2iii), GEA <math display="block">Part 3</math> will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive intravenous (IV) ABBV-400 monotherapy in expansion <math display="block">Part 4</math>, and participants MET amplification will receive intravenous (IV) ABBV-400 monotherapy in expansion <math display="block">Part 5</math>. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Sponsor: AbbVie Intervention: ABBV-400 Start Date: 2021-10-13 Last Updated: 2023-11-02 Number of Patients: 460 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT01613482
Title: TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention Study Summary: Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU. Sponsor: Centre Oscar Lambret Intervention: cerebral prophylactic radiation Start Date: 2007-10 Last Updated: 2012-06-07 Number of Patients: 13 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT05529316
Title: A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma Study Summary: This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy. Sponsor: Agenus Inc. Intervention: Botensilimab Start Date: 2022-12-12 Last Updated: 2023-09-25 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Advanced Melanoma
NCTID: NCT02684006
Title: A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) Study Summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma Sponsor: Pfizer Intervention: Avelumab (MSB0010718C) Start Date: 2016-03-23 Last Updated: 2023-11-09 Number of Patients: 888 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Cancer
NCTID: NCT02715804
Title: A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma Study Summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Sponsor: Halozyme Therapeutics Intervention: Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) Start Date: 2016-03-14 Last Updated: 2020-07-14 Number of Patients: 492 Recruitment Status: TERMINATED Condition: Pancreatic Ductal Carcinoma
NCTID: NCT04547504
Title: PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 % Study Summary: PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee. One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS. Sponsor: University Hospital, Brest Intervention: Pembrolizumab Start Date: 2020-12-22 Last Updated: 2021-03-12 Number of Patients: 292 Recruitment Status: RECRUITING Condition: Non-small-cell Lung Cancer
NCTID: NCT00003304
Title: Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 1998-04 Last Updated: 2012-03-06 Number of Patients: 29 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT02383927
Title: Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations Study Summary: Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open Sponsor: Kura Oncology, Inc. Intervention: Tipifarnib Start Date: 2015-03 Last Updated: 2021-05-14 Number of Patients: 63 Recruitment Status: COMPLETED Condition: Thyroid Cancer
NCTID: NCT04736706
Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-04-14 Last Updated: 2023-11-24 Number of Patients: 1653 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT03670927
Title: Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults Study Summary: Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study. Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma’s patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed. This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process. Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Intervention: Environmental, occupational and lifestyle-related exposures Start Date: 2019-04-25 Last Updated: 2021-08-26 Number of Patients: 6462 Recruitment Status: UNKNOWN Condition: Sarcoma
NCTID: NCT01376752
Title: Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment Study Summary: CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required. Sponsor: UNICANCER Intervention: Maximal cytoreductive surgery Start Date: 2011-04-26 Last Updated: 2023-04-04 Number of Patients: 415 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Epithelial Cancer Recurrent
NCTID: NCT03424005
Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer Study Summary: This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2018-04-02 Last Updated: 2023-11-07 Number of Patients: 242 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT01168752
Title: Study of Debio 0932 in Patients With Advanced Solid Tumours or Lymphoma Study Summary: The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when administered orally, every-other-day or daily during the first 30 days, in patients with solid tumours or lymphoma. Sponsor: Debiopharm International SA Intervention: Debio 0932 Start Date: 2010-04 Last Updated: 2014-02-03 Number of Patients: 81 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT04982926
Title: A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer Study Summary: This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of TAS2940 in patients with advanced or metastatic solid tumors who are not candidates for approved or available therapies. Sponsor: Taiho Oncology, Inc. Intervention: TAS2940 Start Date: 2021-09-16 Last Updated: 2023-11-02 Number of Patients: 42 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT05601752
Title: ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) Study Summary: This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4. Sponsor: Adaptimmune Intervention: Autologous genetically modified ADP-A2M4CD8 cells Start Date: 2023-06-26 Last Updated: 2023-08-28 Number of Patients: 66 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT00006249
Title: Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma Study Summary: RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma. PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: pegylated interferon alfa Start Date: 2000-06 Last Updated: 2015-02-10 Number of Patients: 1258 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT02999152
Title: Validation of Radio-induced Damage Biomarkers Study Summary: The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced bio-markers in plasma and urines, previously described at the preclinical stage. Sponsor: Centre Hospitalier Universitaire de Saint Etienne Intervention: blood and urines samples Start Date: 2017-06-22 Last Updated: 2022-02-22 Number of Patients: 16 Recruitment Status: TERMINATED Condition: Bone Metastasis
NCTID: NCT00848952
Title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis Study Summary: The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis. Sponsor: University Hospital, Angers Intervention: 3 imaging techniques are done Start Date: 2009-03 Last Updated: 2010-02-04 Number of Patients: 450 Recruitment Status: UNKNOWN Condition: Hepatocellular Carcinoma
NCTID: NCT01524926
Title: CREATE: Cross-tumoral Phase 2 With Crizotinib Study Summary: The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Crizotinib (PF-02341066) Start Date: 2012-09 Last Updated: 2023-02-15 Number of Patients: 582 Recruitment Status: COMPLETED Condition: Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma
NCTID: NCT01934452
Title: Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients Study Summary: This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions : Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?) Sponsor: Pfizer Intervention: sunitinib Start Date: 2015-05-21 Last Updated: 2023-11-13 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Complete Remission in Renal Cell Carcinoma
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT01280526
Title: A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas Study Summary: This study is an open label, multicenter study with two phases: * A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma. * An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma. Sponsor: The Lymphoma Academic Research Organisation Intervention: Romidepsin and CHOP Start Date: 2011-01 Last Updated: 2014-05-22 Number of Patients: 37 Recruitment Status: COMPLETED Condition: Peripheral T Cell Lymphoma
NCTID: NCT02304393
Title: A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors Study Summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2014-12-12 Last Updated: 2019-12-13 Number of Patients: 140 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT03123393
Title: TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL. Sponsor: Calithera Biosciences, Inc Intervention: TAK-659 Start Date: 2017-10-10 Last Updated: 2023-02-08 Number of Patients: 49 Recruitment Status: TERMINATED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT00002763
Title: High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma Study Summary: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known whether giving high-dose or low-dose interferon alfa is more effective than no further therapy in treating patients with stage III melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: recombinant interferon alfa Start Date: 1996-04 Last Updated: 2011-11-16 Number of Patients: 1000 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT04882163
Title: Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma Study Summary: This is a Phase 1b/2 randomized study of Iberdomide (CC-220) added to 3 different combination regimens (polatuzumab vedotin plus rituximab (Cohort A), tafasitamab (Cohort B), rituximab plus gemcitabine and platinum-based chemotherapy (Cohort C)) for participants with relapsed or refractory aggressive B-cell lymphoma (R/R a-BCL). All 3 cohorts will be open for enrollment at study start. Part 1 (dose escalation) will be followed by Part 2 (dose expansion), in which participants will be randomized to one of three cohorts, with CC-220 at the recommended Phase 2 Dose in combination with the Cohorts A, B and C treatment that is compared to their individual standard of care regimen. Sponsor: Celgene Intervention: CC-220 Start Date: 2021-10-10 Last Updated: 2021-10-05 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Lymphoma, B-Cell
NCTID: NCT00932893
Title: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene Study Summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug. Sponsor: Pfizer Intervention: PF-02341066 Start Date: 2009-09 Last Updated: 2017-01-02 Number of Patients: 347 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04077463
Title: A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Study Summary: The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D). Sponsor: Janssen Research & Development, LLC Intervention: Lazertinib Start Date: 2019-09-04 Last Updated: 2023-11-08 Number of Patients: 460 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01715363
Title: Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer Study Summary: The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Oxaliplatin Start Date: 2012-07 Last Updated: 2016-02-10 Number of Patients: 3 Recruitment Status: TERMINATED Condition: Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
NCTID: NCT02627963
Title: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) Study Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor <math display="block">programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor</math> plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent). All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. Pharmacokinetic (PK) analyses are also included in study. Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib hydrochloride Start Date: 2016-05-24 Last Updated: 2023-07-18 Number of Patients: 350 Recruitment Status: COMPLETED Condition: Carcinoma, Renal Cell
NCTID: NCT00072293
Title: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases Study Summary: RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases. Sponsor: ETOP IBCSG Partners Foundation Intervention: Axillary lymph node dissection Start Date: 2001-12 Last Updated: 2018-01-23 Number of Patients: 931 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00024193
Title: Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Neuroblastoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation may be an effective treatment for metastatic neuroblastoma. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma. Sponsor: Children’s Cancer and Leukaemia Group Intervention: filgrastim Start Date: 1999-04 Last Updated: 2013-08-07 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Neuroblastoma
NCTID: NCT03838263
Title: Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer Study Summary: The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in “high risk” HPV-driven Oropharynx cancer Sponsor: UNICANCER Intervention: Nivolumab Start Date: 2019-07-25 Last Updated: 2023-05-11 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Oropharynx Cancer
NCTID: NCT00002549
Title: Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: filgrastim Start Date: 1993-11 Last Updated: 2009-12-23 Number of Patients: 1520 Recruitment Status: UNKNOWN Condition: Leukemia
NCTID: NCT03498716
Title: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator’s choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator’s choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer) Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-08-02 Last Updated: 2023-09-15 Number of Patients: 2203 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT00629616
Title: Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer Study Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery. Sponsor: UNICANCER Intervention: anastrozole Start Date: 2007-10 Last Updated: 2021-06-09 Number of Patients: 116 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01574716
Title: Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation Study Summary: This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma. Sponsor: Morphotek Intervention: MORAb-004 Start Date: 2012-08-07 Last Updated: 2019-08-21 Number of Patients: 209 Recruitment Status: COMPLETED Condition: Metastatic Soft Tissue Sarcoma
NCTID: NCT01704716
Title: High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN) Study Summary: This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®). In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned. Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour. Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour. The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed. The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval. Sponsor: St. Anna Kinderkrebsforschung Intervention: Vincristine Start Date: 2002-02 Last Updated: 2020-10-23 Number of Patients: 3300 Recruitment Status: RECRUITING Condition: Neuroblastoma
NCTID: NCT03871816
Title: A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer Study Summary: The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies. Sponsor: Janssen Research & Development, LLC Intervention: Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis Start Date: 2019-04-22 Last Updated: 2023-01-18 Number of Patients: 14532 Recruitment Status: COMPLETED Condition: Metastatic Prostate Cancer
NCTID: NCT04526782
Title: ENCOrafenib With Binimetinib in bRAF NSCLC Study Summary: A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Encorafenib 75 MG Start Date: 2021-01-19 Last Updated: 2022-10-05 Number of Patients: 119 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT01283945
Title: Study of Oral Lucitanib (E-3810), a Dual VEGFR-FGFR Tyrosine Kinase Inhibitor, in Patients With Solid Tumors Study Summary: Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two most relevant players in tumor angiogenesis and simultaneously targeting proliferation in FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2, 3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make it an attractive candidate for development in humans. This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally, once daily, on a continuous schedule over the initial 28-day cycle. Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics and antitumour activity of Lucitanib, given as a single agent to adult patients with advanced solid tumours. The study consists of two phases, a dose escalation phase followed by a dose-expansion phase at the identified Recommended Dose (RD). Eligible patients have histologically or cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or 11q 12-14 amplification, assessed by FISH or CGH array, or “sensitive” to antiangiogenic treatment. These latter are defined as patients who have relapsed after having experienced stable disease (lasting at least six months) or partial response with prior treatment with an approved antiangiogenic regimen or patients with tumour types known to be potentially responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic agents were approved and/or available for that specific condition (e.g thyroid cancer, thymic carcinoma). Serial safety assessments, including evaluation of symptoms, physical examination and blood and urine laboratory analyses are performed throughout the study. Cardiac functions and blood pressure are monitored in consultation with a cardiologist. PK parameters are determined on plasma samples collected during the first 4-week cycle and analyzed using a validated LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of angiogenesis biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and PIGF(by ELISA) and circulating endothelial and progenitors cells (CEC and CEP). Tumor response is based on imaging according to RECIST; circulating tumor cells (CTC) are measured by the immunomagnetic CellSearch method. In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30, power 0,80. Sponsor: Institut de Recherches Internationales Servier Intervention: Lucitanib Start Date: 2010-07 Last Updated: 2020-01-03 Number of Patients: 134 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT04044768
Title: Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma Study Summary: This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) . Sponsor: Adaptimmune Intervention: afamitresgene autoleucel (previously ADP-A2M4) Start Date: 2019-08-13 Last Updated: 2023-08-15 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Synovial Sarcoma
NCTID: NCT02673268
Title: Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction Study Summary: The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis. The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm. The aim is also to study the rate of complications, cosmetic results and quality of life. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Mastectomy Start Date: 2015-11-25 Last Updated: 2017-10-12 Number of Patients: 80 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT05135845
Title: Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma Study Summary: Immunotherapy with anti-PD1 antibodies provides encouraging results on a subset of patients. Capmatinib, a MET inhibitor, has shown an imunomodulatory effect and a synergy with spartalizumab a PD-1 inhibitor. The purpose of this phase II trial is to evaluate the efficacy and safety of the combination of capmatinib + spartalizumab in adult patients with advanced oesogastric adenocarcinoma. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: Capmatinib Start Date: 2022-03-22 Last Updated: 2023-02-03 Number of Patients: 90 Recruitment Status: SUSPENDED Condition: Oesophageal Adenocarcinoma
NCTID: NCT02324205
Title: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT) Study Summary: The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures. Sponsor: GE Healthcare Intervention: DBT and FFDM Start Date: 2015-03 Last Updated: 2019-02-26 Number of Patients: 196 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT03555149
Title: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) Study Summary: A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms. Sponsor: Hoffmann-La Roche Intervention: Regorafenib Start Date: 2018-09-27 Last Updated: 2023-11-07 Number of Patients: 96 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT05364905
Title: Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma Study Summary: This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma. Sponsor: ARCAGY/ GINECO GROUP Intervention: Chemotherapy Start Date: 2022-05-09 Last Updated: 2023-09-06 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Oncology
NCTID: NCT02240017
Title: A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. Study Summary: This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included. Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm: * Fractionated Cisplatin + Gemcitabine. * Carboplatin + Gemcitabine. The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population. The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population. Sponsor: Institut Claudius Regaud Intervention: Carboplatin Start Date: 2015-01-21 Last Updated: 2019-08-09 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Advanced Urothelial Cancer
NCTID: NCT03768063
Title: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study Study Summary: This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-02-28 Last Updated: 2023-11-09 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT04290663
Title: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Study Summary: This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy Sponsor: Centre Francois Baclesse Intervention: Systematic RAI-treatment Start Date: 2020-03-02 Last Updated: 2023-09-07 Number of Patients: 476 Recruitment Status: RECRUITING Condition: Thyroid Cancer
NCTID: NCT00544349
Title: Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: cetuximab Start Date: 2006-10 Last Updated: 2011-05-17 Number of Patients: 45 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT05874063
Title: Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors Study Summary: The goal of this clinical trial is to assess the efficacy of thromboprophylaxis in preventing venous thromboembolic events (VTE) in good and intermediate prognosis patients with metastatic germ cell cancer (GCT) undergoing first-line cisplatin-based chemotherapy with risk factors for developing a thromboembolic event . The high-risk patients will be randomized between two treatments arm (receiving a thromboprophylaxis in the experimental arm, or no thromboprophylaxis in the control arm). The low-risk patients will be observed without any thromboprophylaxis. Patients will participate in the study for 14-17 weeks depending on the planned number of cycles of chemotherapy. Researchers will compare an experimental arm with thromboprophylaxis and a control arm without thromboprophylaxis to detect an absolute decrease of 12% of the proportion of patients having experienced a VTE, from 21% (high risk patients, control arm) to 9% (high risk patients, experimental arm). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Thromboprophylaxis Start Date: 2023-10-17 Last Updated: 2023-10-19 Number of Patients: 387 Recruitment Status: RECRUITING Condition: Germ Cell Tumor
NCTID: NCT02280993
Title: Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients Study Summary: To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS). Sponsor: Marjolein Spiering Intervention: DHAP Start Date: 2014-05 Last Updated: 2018-03-13 Number of Patients: 72 Recruitment Status: UNKNOWN Condition: Hodgkin Lymphoma
NCTID: NCT02864563
Title: Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification Study Summary: Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic pattern is an important prognostic marker which might be taken into account for treatment stratification. This protocol deals with a prospective analysis of the genomic profile established by CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in France, to obtain genomic profiles and being able to determine their prognostic impact in the various protocols of treatment. The objective of this study will be a better therapeutic stratification in the future trials, studies or protocols of treatment. Sponsor: Institut Curie Intervention: Blood sampling Start Date: 2008-10-04 Last Updated: 2023-10-12 Number of Patients: 500 Recruitment Status: COMPLETED Condition: Neuroblastoma
NCTID: NCT03834493
Title: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-28 Last Updated: 2023-06-15 Number of Patients: 1244 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT03834506
Title: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-02 Last Updated: 2023-08-25 Number of Patients: 1030 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms
NCTID: NCT05122806
Title: Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC Study Summary: BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients. BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study. Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA). For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon). Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital. Sponsor: Groupe Francais De Pneumo-Cancerologie Intervention: RNAseq Start Date: 2021-09-22 Last Updated: 2023-10-19 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT00433706
Title: Image Guided Radiation Therapy For Prostate Cancer Study Summary: During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Control position by 3DOBI before the fraction Start Date: 2007-06 Last Updated: 2016-12-13 Number of Patients: 470 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03673306
Title: Safety of Pregnancy in BRCA Mutated Breast Cancer Patients Study Summary: The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer. Sponsor: Jules Bordet Institute Intervention: Clinical outcomes Start Date: 2017-01-16 Last Updated: 2018-09-17 Number of Patients: 2200 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT03136627
Title: Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC Study Summary: This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with metastatic renal cell cancer. This will use a standard ‘3+3’ dose-escalation trial design. A cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6 subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6 subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will be considered the MTD. This is a validated trial design for Phase 1 trials. Following completion of the dose-escalation cohorts and determination of MTD, an expansion cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same target population. Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib Start Date: 2017-03-22 Last Updated: 2021-12-06 Number of Patients: 28 Recruitment Status: COMPLETED Condition: Carcinoma, Renal Cell
NCTID: NCT01740427
Title: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) Study Summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease. Sponsor: Pfizer Intervention: PD-0332991 Start Date: 2013-02-22 Last Updated: 2022-12-08 Number of Patients: 666 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasms
NCTID: NCT03518606
Title: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours Study Summary: This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours. Sponsor: UNICANCER Intervention: Durvalumab + Tremelimumab + metronomic Vinorelbine Start Date: 2018-06-20 Last Updated: 2023-09-06 Number of Patients: 150 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumours
NCTID: NCT03651206
Title: Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib Study Summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options. Sponsor: ARCAGY/ GINECO GROUP Intervention: Niraparib Start Date: 2020-07-15 Last Updated: 2023-07-06 Number of Patients: 196 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Carcinosarcoma
NCTID: NCT05180006
Title: Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy Study Summary: The aim of this study is to determine, using immunohistochemistry (IHC) on biopsies and surgically removed tumor if short-treatment immunotherapy with atezolizumab monotherapy or in combination with other biologic agents (ipatasertib / Bevacizumab / Trastuzumab / Pertuzumab) is associated with increased levels of activated GzmB+ CD8+ T cells from baseline to post treatment sample. Moreover, from baseline to post treatment sample, evolution of others biomarkers will be studied : GzmB/CD8, CD8/FoxP3, CD8/CD68 in IHC, cell proliferation, PD-L1, MHC-I, change in gene expression (RNA-Seq). Tjis study aim also to assess the safety and tolerability of study treatments in this population and to determine the effect of short-term immunotherapy treatment in pCR at surgery. Patients will undergo tumor biopsies at screening and 15 days after the beginning of treatment (if they start neoadjuvant chemotherapy) / at surgery, in order to evaluate in IHC evolution of activated GzmB+ CD8+ T cells and evaluate other markers It targets 2 different cohorts: newly diagnosed, non-metastatic early-stage triple-negative (TNBC) or HER2+ breast cancer. TNBC cohort is composed of 4 open-label, randomized arms, HER2+ of 2 arms. A maximum of 210 patients will be included in the trial (147 in TNBC cohort and 63 in HER2+ cohort). Tumor evaluation will be performed by clinical examination and Breast echography at baseline and end of treatment visit. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests and through the collection of ongoing toxicities or adverse events. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Atezolizumab Injection Start Date: 2022-02-24 Last Updated: 2023-03-20 Number of Patients: 210 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT04925609
Title: Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors Study Summary: This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children. Sponsor: Princess Maxima Center for Pediatric Oncology Intervention: Brigatinib Start Date: 2022-08-18 Last Updated: 2022-09-28 Number of Patients: 65 Recruitment Status: RECRUITING Condition: Anaplastic Large Cell Lymphoma, ALK-Positive
NCTID: NCT05215106
Title: Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva) Study Summary: This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small (cT1N0) triple negative breast cancer tumors. This study will recruit patients with early HR-negative breast cancer all invasive types (ER < 1%, PR < 1%, HER2 negative) and TILs >=5%, eligible for a short-term treatment with Durvalumab. A total of 200 patients are planned to be enrolled in the study and which will receive 2 administrations of durvalumab 10mg/kg. After study treatment, patients: * In whom surgery is the first standard treatment strategy (i.e. after study treatment) no biopsy is required at the end-of-treatment visit. * In whom neo adjuvant therapy is the first standard treatment strategy (i.e. after study treatment) a breast ultrasound guided biopsy is mandatory at the EoT visit. If the biopsy-proven residual disease is demonstrated, patients will have the option to receive standard neoadjuvant therapy at the discretion of the treating investigator. Those with a complete response may proceed directly to surgery. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Durvalumab Start Date: 2021-12-06 Last Updated: 2023-06-06 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Early Small (cT1N0) Triple Negative Breast Cancer
NCTID: NCT05307705
Title: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors Study Summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse. Sponsor: Eli Lilly and Company Intervention: LOXO-783 Start Date: 2022-05-11 Last Updated: 2023-11-02 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03615326
Title: Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) Study Summary: The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-10-05 Last Updated: 2022-07-22 Number of Patients: 732 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric Neoplasms
NCTID: NCT03797326
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) Study Summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-02-12 Last Updated: 2023-10-31 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT05384626
Title: A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) Study Summary: Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors. Sponsor: Nuvalent Inc. Intervention: NVL-655 Start Date: 2022-06-09 Last Updated: 2023-09-28 Number of Patients: 214 Recruitment Status: RECRUITING Condition: Locally Advanced Solid Tumor
NCTID: NCT00158652
Title: Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC Study Summary: This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Conventional radiotherapy 70 Gy in 7 weeks Start Date: 2000-03 Last Updated: 2011-11-08 Number of Patients: 840 Recruitment Status: COMPLETED Condition: Oral Cancer
NCTID: NCT00003852
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy. Sponsor: UNICANCER Intervention: filgrastim Start Date: 1998-03 Last Updated: 2016-06-23 Number of Patients: 45 Recruitment Status: TERMINATED Condition: Childhood Germ Cell Tumor
NCTID: NCT01956552
Title: Changes in Phenotype and Genotype of Breast Cancers During the Metastatic Process and Optimization of Therapeutic Targeting (ESOPE) Study Summary: The primary objective is to compare the phenotype and genotype of the primary tumor with those of its metastases in order to optimize the treatment of metastatic disease, in patients presenting with first metastatic progression of breast cancer. Sponsor: Institut Curie Intervention: biopsy or cytopuncture Start Date: 2009-11 Last Updated: 2016-07-12 Number of Patients: 130 Recruitment Status: TERMINATED Condition: Metastatic Breast Cancer
NCTID: NCT00408252
Title: Efficacy of SU 011248 in Head And Neck Carcinoma Study Summary: Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients. Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain Intervention: biopsies Start Date: 2007-02 Last Updated: 2019-09-19 Number of Patients: 54 Recruitment Status: TERMINATED Condition: Recurrent Disease
NCTID: NCT00075452
Title: Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma. PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: gemcitabine hydrochloride Start Date: 2003-11 Last Updated: 2008-07-24 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Pancreatic Cancer
NCTID: NCT00421317
Title: Imatinib in Adult Patients With Metastatic Ocular Melanoma Study Summary: The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients. Sponsor: Centre Oscar Lambret Intervention: Imatinib Start Date: 2005-12 Last Updated: 2016-01-06 Number of Patients: 13 Recruitment Status: TERMINATED Condition: Melanoma
NCTID: NCT00005826
Title: Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have glioblastoma multiforme. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rubitecan Start Date: 2000-03 Last Updated: 2012-09-24 Number of Patients: 17 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT04464226
Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. Sponsor: Bayer Intervention: Darolutamide (Nubeqa, BAY1841788) Start Date: 2020-10-20 Last Updated: 2023-11-18 Number of Patients: 678 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT01875705
Title: A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors Study Summary: This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of GDC-0994 determined in Stage I. Sponsor: Genentech, Inc. Intervention: GDC-0994 Start Date: 2013-06-21 Last Updated: 2018-04-06 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Solid Tumor
NCTID: NCT00005052
Title: Vaccine Therapy in Treating Patients With Primary Stage II Melanoma Study Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma. PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: GM2-KLH vaccine Start Date: 1999-12 Last Updated: 2009-02-09 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT02679963
Title: Trial Evaluating Maintenance Olaparib in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer
Study Summary: This is a multicentre randomised double-blind phase II trial, sponsored by Gustave Roussy and involving one French center as well as the Spanish Lung Cancer Group (≈20 centers of the SLCG). Six hundred patients with diagnosis of stage IIIB/IV NSCLC will initially be registered prior to receiving the first line platinum-based chemotherapy or during or at the end of the first 6 cycles of inducation platinium based chemotherapy and provide consent for retrieving archival tissue collection and providing translational blood samples and tumor biopsies.
- Induction chemotherapy phase All patients will initially be treated with 6 cycles of platinum-based induction chemotherapy. Cycle duration will be 21 days. Doublets should either consist of a pemetrexed-platinum (cisplatin or carboplatin) doublet (preferentially for non-squamous NSCLC) or a gemcitabine - or vinorelbine - platinum doublet for squamous NSCLC. Taxanes-platinum doublets will not be accepted. Translational blood samples will be taken at the beginning of induction chemotherapy for all patients.
- Randomisation and maintenance phase Only patients who respond to platinum-based induction chemotherapy will be further randomised between olaparib and placebo. These patients must have been treated with 6 cycles of chemotherapy. However, patients who haven’t received 6 cycles of the induction chemotherapy due to severe toxicity (grade 3 or 4, NCI CTCAE v4.0) could be randomized only if they had received 4 chemotherapy cycles at least and if all treatment related toxicities are resolved to a grade ≤ 1 (NCI CTCAE v4.0).
Treatment will be administered at a dose of 600 mg daily (2 doses of 300 mg <math display="block">2 tablets of 150 mg</math> taken approximately 12 hours apart) and cycle duration will be 28 days. Disease will be assessed every 2 cycles by CTscan (MRI or PET-scan if the scan is not contributive) and treatment will be administered until disease progression or unacceptable toxicity. Patients will then be optimally managed according to local practice. Follow-up will be for a minimum of 15 months from the time of randomization, and until last venue. All randomised patients will be asked to provide translational blood samples at randomization, on treatment and at the end of the treatment. Optional tumour biopsies will be performed at randomization, at the end of the treatment (or at disease progression if available).
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Olaparib Start Date: 2016-01 Last Updated: 2017-08-01 Number of Patients: 600 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer
NCTID: NCT05463263
Title: A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas Study Summary: The Phase 1 part of the study is a dose escalation of STP938 as monotherapy. The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas. Sponsor: Step Pharma, SAS Intervention: STP938 Start Date: 2022-08-03 Last Updated: 2023-09-21 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Lymphoma, B-Cell
NCTID: NCT00351949
Title: IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC) Study Summary: Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting Sponsor: Immutep S.A.S. Intervention: IMP321 Start Date: 2005-09 Last Updated: 2010-01-07 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Stage IV Renal Cell Carcinoma
NCTID: NCT00295763
Title: A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen. Study Summary: Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid gland that may have been missed during surgery. It is thought that ablation with radioiodine destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid area or at other sites. Following successful treatment, patients are then monitored by their physicians at regular intervals with testing to detect any recurrence of thyroid cancer throughout the body. If thyroid cells are detected by these follow up tests, the physician will decide the best method to re-treat the patient. In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to accomplish radioiodine ablation treatment. This study aimed to determine that the success rates of radioiodine ablation were comparable when patients were prepared for ablation with Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively, by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side effects for patients, and these might be avoided by the use of Thyrogen. Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The results of this testing showed that all patients (in both groups) had successfully achieved remnant ablation and had no detectable thyroid tissue remaining. In order to confirm these remnant ablation results we will conduct follow up testing in this study for all patients that were enrolled in the previous study and we also will determine if their thyroid cancer has recurred. Only patients who completed this previous Thyrogen ablation study are eligible for entry into this study. Sponsor: Genzyme, a Sanofi Company Intervention: Thyrogen (thyrotropin alfa for injection) Start Date: 2006-05 Last Updated: 2015-03-18 Number of Patients: 61 Recruitment Status: COMPLETED Condition: Differentiated Thyroid Cancer
NCTID: NCT02856893
Title: Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE) Study Summary: The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Osimertinib Start Date: 2017-10-10 Last Updated: 2022-09-15 Number of Patients: 156 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: NSCLC
NCTID: NCT05378204
Title: Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer. Study Summary: The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1/2 mutations. This translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer: * The main study concerns 80 patients eligible for PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration. * The sub-study concerns 40 patients in progression disease under PARPi alone. For each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study. Sponsor: Institut Claudius Regaud Intervention: Main study: Start Date: 2022-06-23 Last Updated: 2023-07-13 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03969004
Title: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Study Summary: The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum Sponsor: Regeneron Pharmaceuticals Intervention: Cemiplimab Start Date: 2019-06-04 Last Updated: 2023-11-24 Number of Patients: 412 Recruitment Status: RECRUITING Condition: Cutaneous Squamous Cell Carcinoma
NCTID: NCT00002904
Title: Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: trabectedin Start Date: 1996-02 Last Updated: 2012-07-02 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT00083304
Title: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer Study Summary: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Efaproxiral Start Date: 2004-02 Last Updated: 2013-05-10 Number of Patients: 368 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04015804
Title: Robotic Low Rectum Anterior Resection Study Summary: The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon’s simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Clinical database Start Date: 2015-03 Last Updated: 2022-11-18 Number of Patients: 833 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectum Cancer
NCTID: NCT03604627
Title: Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation Study Summary: To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Coronal calcium score measurement Start Date: 2018-06-14 Last Updated: 2023-05-17 Number of Patients: 300 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Childhood Cancer
NCTID: NCT04675827
Title: De-escalation Adjuvant Chemo in HER2+/ER-
ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade
Study Summary: DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment). Sponsor: Jules Bordet Institute Intervention: Pertuzumab and tratuzumab fixed dose combination Start Date: 2022-01-17 Last Updated: 2023-09-05 Number of Patients: 1065 Recruitment Status: SUSPENDED Condition: HER2-positive Breast Cancer
NCTID: NCT02672527
Title: Trial Comparing Trabectedin to the Best Supportive Care in Patients With Sarcoma Study Summary: As the transparency committee of the Haute Autorité de Santé pointed out due to lack of data regarding comparative trial of Yondelis versus best supportive care, activity of Yondelis in soft tissue sarcoma remain to be assessed. For an antineoplastic drug toxicity is moderate. As previous studies shown, overall survival data for patients with advanced or metastatic STS are of poor prognosis despite improvement of results this last years. For example, median overall survival increased from 12,3 months (1987-1991) to 11,4 months (1992-1996) and then 18 months (2002-2006). Considering the latest results with and without Trabectedin, the investigators may consider that comparing Trabectedin with best supportive care is ethically acceptable as long as patients consent to enter the trial. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Trabectedin Start Date: 2015-01-22 Last Updated: 2018-08-16 Number of Patients: 103 Recruitment Status: COMPLETED Condition: Soft Tissue Sarcoma
NCTID: NCT05551117
Title: A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer Study Summary: Study CP-MGC018-03 is a randomized, open-label, Phase 2 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior taxane-containing regimen, but no other chemotherapy agents. The study will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg every 4 weeks <math display="block">Q4W</math> and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor. An analysis of radiographic progression-free survival (rPFS) will occur after 100 participants have been on-study for at least 6 months. Sponsor: MacroGenics Intervention: vobramitamab duocarmazine 2.0 mg (Arm A) Start Date: 2023-06-13 Last Updated: 2023-11-13 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Castration-Resistant Prostatic Cancer
NCTID: NCT01712217
Title: A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib Study Summary: The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer. Sponsor: Astex Pharmaceuticals, Inc. Intervention: AT13387 Start Date: 2012-10 Last Updated: 2018-01-19 Number of Patients: 220 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer(NSCLC)
NCTID: NCT05491317
Title: A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors Study Summary: The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors. Sponsor: Genmab Intervention: GEN1042 Start Date: 2023-03-08 Last Updated: 2023-11-07 Number of Patients: 88 Recruitment Status: RECRUITING Condition: Non-CNS Tumor
NCTID: NCT03428217
Title: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma Study Summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC). Sponsor: Calithera Biosciences, Inc Intervention: CB-839 Start Date: 2018-04-24 Last Updated: 2023-03-20 Number of Patients: 444 Recruitment Status: COMPLETED Condition: Advanced Renal Cell Carcinoma
NCTID: NCT02375204
Title: Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors Study Summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors. Sponsor: Alliance for Clinical Trials in Oncology Intervention: paclitaxel Start Date: 2015-08-05 Last Updated: 2023-08-31 Number of Patients: 420 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Germ Cell Tumor
NCTID: NCT03390504
Title: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Study Summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-<math display="block">L</math>1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2018-03-23 Last Updated: 2023-11-13 Number of Patients: 629 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Cancer
NCTID: NCT03186326
Title: Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer Study Summary: Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC representing approximately 15% of the CRCs exhibits a high mutational load which generates many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i) the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is controversial. Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1 alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4) was tested in the MSI CRCs and a selection of interesting results in heavily pretreated patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy. Anti-PD1s now have marketing authorization for patients with melanoma and metastatic pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be as promising in MSI CRCs as in other tumors and therefore face the same major challenges. Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with promising results and is currently being studied in phase III in gastric cancer. There is no data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the 2nd line of treatment in patients with a MSI mCRC progression after standard 1st line chemotherapy +/- targeted therapy. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: FOLFOX regimen Start Date: 2018-04-24 Last Updated: 2022-08-19 Number of Patients: 132 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT05297617
Title: Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk Study Summary: Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women. Adjuvant endocrine therapy (ET) is associated with substantial side effects and long-term decreased quality of life. Moreover, while it has been shown that ET provides a real benefit in reducing the relapse rate over time, the deterioration in quality of life may also have a negative effect on patient adherence to treatment. It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies. If recent trials tested longer durations as compared to 5 years for high-risk cancers, older trials have tested shorter durations. The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients. However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients. Sponsor: UNICANCER Intervention: Anti-aromatase inhibitor Start Date: 2022-10-12 Last Updated: 2022-12-21 Number of Patients: 696 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03780517
Title: Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors Study Summary: This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738. Sponsor: Boston Pharmaceuticals Intervention: BOS172738 Start Date: 2018-12-12 Last Updated: 2023-10-30 Number of Patients: 117 Recruitment Status: COMPLETED Condition: Advanced Nonhaematologic Malignancies
NCTID: NCT03576417
Title: A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck Study Summary: The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint ) Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Cisplatin Start Date: 2018-10-10 Last Updated: 2023-09-22 Number of Patients: 680 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04187404
Title: A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma Study Summary: This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma. Sponsor: Enterome Intervention: EO2401 Start Date: 2020-07-23 Last Updated: 2023-08-25 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Adrenocortical Carcinoma
NCTID: NCT01986426
Title: LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab Study Summary: The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab. Sponsor: Lytix Biopharma AS Intervention: LTX-315 consecutive lesions Start Date: 2013-11 Last Updated: 2018-10-03 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT04349293
Title: Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways Study Summary: Multicentric interventional prospective study with collection of biological samples as part of a routine care research Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Tissue sampling Start Date: 2016-09-08 Last Updated: 2020-04-16 Number of Patients: 150 Recruitment Status: UNKNOWN Condition: Cancer
NCTID: NCT02220049
Title: Dose Escalation of Velcade Daily Dose in Patients With Solid Tumors Study Summary: VELCADE has demonstrated marked activity in haematological cancers leading to registration (MM, MCL). Currently only biweekly or weekly regimens have been explored. Key signalling pathways which are aberrant in haematological cancers are also present in solid tumors. VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a single agent & in combination with chemotherapy in solid cancers has shown modest and real anti-tumor activity but insufficient for Phase III development. VELCADE PK exposure may be inadequate in solid tumors compared to “liquid cancers.” VELCADE daily low dose administration may allow a greater PK exposure to be achieved, which is tolerated Hypotheses: VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the threshold required for clinically significant anti-tumor activity in solid cancers). Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have increased anti-tumor activity compared to monotherapy alone. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Bortezomib Start Date: 2010-12 Last Updated: 2016-03-25 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Advanced or Metastatic Solid Tumors
NCTID: NCT02215720
Title: Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors Study Summary: Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal cancer or head and neck cancer in several phase II/III studies. Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II studies in advance kidney cancer of bad prognosis. Study hypothesis is that combination of those two compounds and the inhibition of two pathways at the same time will have more efficiency on tumoral growth than the inhibition of those pathways in isolation. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Cetuximab Start Date: 2011-04 Last Updated: 2016-02-10 Number of Patients: 42 Recruitment Status: UNKNOWN Condition: Patients With Advanced or Metastatic Solid Tumors
NCTID: NCT02659020
Title: A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma Study Summary: The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body. Sponsor: Eli Lilly and Company Intervention: Olaratumab Start Date: 2016-03-01 Last Updated: 2022-05-09 Number of Patients: 310 Recruitment Status: COMPLETED Condition: Soft Tissue Sarcoma
NCTID: NCT03842982
Title: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) Study Summary: This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone. Sponsor: Centre Oscar Lambret Intervention: HIPEC Start Date: 2019-04-01 Last Updated: 2022-12-07 Number of Patients: 362 Recruitment Status: RECRUITING Condition: Ovary Neoplasms
NCTID: NCT02266420
Title: Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm Study Summary: This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm. All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause. At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research. A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA). Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection. Sponsor: Institut Claudius Regaud Intervention: Blood samples of 10 mL Start Date: 2014-10-23 Last Updated: 2023-08-03 Number of Patients: 151 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm
NCTID: NCT00918320
Title: Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours Study Summary: The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Temozolomide/Hycamtin (Topotecan) Start Date: 2009-06 Last Updated: 2016-01-26 Number of Patients: 129 Recruitment Status: COMPLETED Condition: Neuroblastoma
NCTID: NCT04174820
Title: Child’s Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition Study Summary: One of the major complications of posterior fossa surgery is Posterior Fossa Syndrome (PFS). This syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. PFS is thought to be related to axonal lesions. The long-term consequences on the cognitive and psychosocial sphere of PFS have been widely documented. On the other hand, the literature concerning the consequences of this syndrome on language is much restricted. Beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great “conductor” who would underlie the learning of most motor and cognitive automatisms. Sponsor: University Hospital, Angers Intervention: Functional Magnetic Resonance Imaging (fMRI) Start Date: 2020-11-12 Last Updated: 2020-11-19 Number of Patients: 145 Recruitment Status: UNKNOWN Condition: Medulloblastoma, Childhood
NCTID: NCT03834220
Title: Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) Study Summary: The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement. Sponsor: Debiopharm International SA Intervention: Debio 1347 Start Date: 2019-03-22 Last Updated: 2022-04-04 Number of Patients: 63 Recruitment Status: TERMINATED Condition: Solid Tumor
NCTID: NCT04954820
Title: Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET Study Summary: In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Lutathera Start Date: 2021-10-18 Last Updated: 2023-06-07 Number of Patients: 146 Recruitment Status: RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT03012620
Title: Secured Access to Pembrolizumab for Patients With Selected Rare Cancer Types Study Summary: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of pembrolizumab monotherapy in 7 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available, in order to identify subsets of patients that may benefit from treatment Sponsor: UNICANCER Intervention: Pembrolizumab Start Date: 2017-07-05 Last Updated: 2023-02-08 Number of Patients: 334 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Sarcoma
NCTID: NCT04055220
Title: Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas Study Summary: This is a randomized, double-blinded, 2 arms study concerning patients with bone sarcoma after the first line therapy. In the first arm, patients will be treated with regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be treated with placebo (standard of care). The comparison between this two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement. Sponsor: Centre Leon Berard Intervention: Treatment by Regorafenib Start Date: 2020-03-03 Last Updated: 2023-08-08 Number of Patients: 168 Recruitment Status: RECRUITING Condition: Bone Sarcoma
NCTID: NCT01788982
Title: Nintedanib(BIBF1120) in Thyroid Cancer Study Summary: For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature. In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well. Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC. Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nintedanib Start Date: 2014-05 Last Updated: 2020-07-31 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Medullary Thyroid Cancer (MTC)
NCTID: NCT00003982
Title: MEN-10755 in Treating Patients With Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: sabarubicin Start Date: 1997-06 Last Updated: 2012-07-11 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Testicular Germ Cell Tumor
NCTID: NCT02896582
Title: Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance Study Summary: This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance Sponsor: The Lymphoma Academic Research Organisation Intervention: Obinutuzumab Start Date: 2016-10 Last Updated: 2023-01-10 Number of Patients: 86 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT04648020
Title: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. Study Summary: This study is being performed to evaluate the effectiveness of a new drug, clonidine HCl MBT, to prevent the onset of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) who are being treated with chemoradiotherapy. OPC occurs on the back of the tongue or throat and is often treated by the use of chemoradiotherapy, where radiation is localized to these areas. Radiation to the OPC affected tissues causes the release of small proteins called cytokines that cause damage to the area surrounding the tumor including the oral cavity. This damage is characterized by the formation of mucositis which includes redness, pain and ulcers in the mouth and back of the throat. In addition, as more chemoradiation is administered to treat OPC, the inability to eat a solid diet (a Grade 3 mucositis) or to consume anything at all by mouth (a Grade 4 mucositis) occurs in many patients. Collectively, Grade 3 and Grade 4 mucositis is referred to as SOM. It is a frequent, debilitating side effect of chemoradiation in OPC that may cause patients to stop or interrupt their treatment, develop other side effects like the inability to swallow, or require the increased use of pain medications. OPC survivors who have successful treatment of their tumors often develop permanent swallowing, speaking and range of motion issues that may be linked back to the inability to eat and/or drink caused by SOM during their chemoradiotherapy treatment. Clonidine may inhibit the production of cytokines that cause SOM and clonidine HCl mucoadhesive buccal tablet (MBT) has been designed to deliver sustained high levels of clonidine in the oral cavity, potentially decreasing cytokine production and leading to a decrease in the incidence of SOM. Clonidine HCl MBT is a once per day treatment provided as a tablet that a patient may self-administer to the gums, where it sticks tightly to release clonidine over many hours. The primary objective of this Phase 2b/3 study is to evaluate whether clonidine HCl MBT is more effective than placebo MBT in decreasing the incidence of SOM. Sponsor: Monopar Therapeutics Intervention: Clonidine HCl Mucoadhesive Buccal Tablet Start Date: 2021-02-11 Last Updated: 2023-05-31 Number of Patients: 190 Recruitment Status: TERMINATED Condition: Chemoradiotherapy-Induced Severe Oral Mucositis
NCTID: NCT04773782
Title: A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling Study Summary: This is a Phase 1/2, multicenter, open-label trial of avapritinib in participants 2 to < 18 years of age with advanced relapsed/refractory (R/R) solid tumors, including central nervous system (CNS) tumors, that harbor a PDGFRA and/or KIT mutation (including non-synonymous point mutations, insertions, and deletions) or amplification, or DMG-H3K27a who have no available curative treatment options. This is a single-arm trial in which all participants will receive avapritinib. The study consists of 2 parts: dose confirmation, safety, and PK (Part 1) and initial efficacy, safety, and PK at the Part 2 recommended dose (Part 2). Sponsor: Blueprint Medicines Corporation Intervention: avapritinib Start Date: 2022-02-24 Last Updated: 2023-06-15 Number of Patients: 37 Recruitment Status: RECRUITING Condition: Solid Tumor, Unspecified, Child
NCTID: NCT00140582
Title: Primary Rituximab and Maintenance Study Summary: * Objectives * Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy * Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma. * Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years. Sponsor: Lymphoma Study Association Intervention: Rituximab Start Date: 2004-12 Last Updated: 2017-03-13 Number of Patients: 1217 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT03102320
Title: Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors Study Summary: The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor’s objective response rate. Radiological tumor assessments will be performed at defined time points until the patient’s disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses. Sponsor: Bayer Intervention: Cisplatin Start Date: 2017-05-26 Last Updated: 2022-06-30 Number of Patients: 173 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT02393820
Title: Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma Study Summary: Open-label, multicenter, single arm phase II study, set up in collaboration with the “Réseau d’Expertise Français sur les Cancers ORL Rares” (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC). Sponsor: UNICANCER Intervention: pazopanib Start Date: 2013-08-26 Last Updated: 2019-10-29 Number of Patients: 72 Recruitment Status: COMPLETED Condition: Salivary Gland Carcinoma
NCTID: NCT04102020
Title: A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy Study Summary: This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed. Sponsor: AbbVie Intervention: Venetoclax Start Date: 2020-03-26 Last Updated: 2023-10-25 Number of Patients: 112 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT02672020
Title: Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card Study Summary: Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers improved thanks to the French COMETE network originally based on two clinical centers (HEGP and Cochin) well organized for clinical and biological samples collection. Over the last 10 years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and oncogenesis of these tumors and identified molecular signatures discriminating between benign and malignant cancers by integrated genomic approaches. This strategy was highly successful in delivering new diagnostic applications of genomics technologies that now appear as potentially suitable for rapid implementation in routine clinical care. The main objective of COMETE-TACTIC is to provide an easy-to-use “identity card” of the adrenal tumors that will allow a personalized “à la carte” management of the patient and, when indicated, to the indication of the most accurate molecular targeted therapy. We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options proposed to affected patients will require, # the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers); # the implementation of the translational research projects based on the COMETE collection to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic biomarkers that could be used as non-invasive “liquid biopsies”. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: omics identity card Start Date: 2015-11 Last Updated: 2019-09-24 Number of Patients: 448 Recruitment Status: COMPLETED Condition: Adrenal Gland Neoplasms
NCTID: NCT00180882
Title: LMBA02 Protocol for Patients With a Burkitt Lymphoma Study Summary: To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: rituximab Start Date: 2004-10 Last Updated: 2006-09-11 Number of Patients: 260 Recruitment Status: UNKNOWN Condition: Burkitt Lymphoma
NCTID: NCT02163720
Title: Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON) Study Summary: The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse. Sponsor: ARCAGY/ GINECO GROUP Intervention: Yondelis®-Caelyx® Start Date: 2014-07-10 Last Updated: 2020-09-30 Number of Patients: 101 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT01556191
Title: Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR Study Summary: Lung Cancer is to become the first cause of death related to cancer in France as it’s already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above. * One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy. * Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis. * Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models. EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations. The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways . Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Gefitinib Start Date: 2012-05-15 Last Updated: 2021-01-08 Number of Patients: 379 Recruitment Status: COMPLETED Condition: Stage IV Lung Cancer
NCTID: NCT01212991
Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2010-09-16 Last Updated: 2020-03-17 Number of Patients: 1717 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04527991
Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician’s Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer Study Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician’s choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2021-01-13 Last Updated: 2023-06-22 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Unresectable Urothelial Cancer
NCTID: NCT00910091
Title: The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer Study Summary: This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer. Sponsor: Ipsen Intervention: BN83495 Start Date: 2009-08 Last Updated: 2019-01-30 Number of Patients: 73 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT05691608
Title: MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 Study Summary: FMG2025 continues the previous efforts to propose treatment for patients based on the molecular characteristics of their tumor at treatment failure in cancer precision medicine trials within standard of care in France. However, whereas FMG2025 is a descriptive effort providing the basis for clinical decisions, MAPPYACTS 2 will translate these findings to clinical actions. The symbiosis is critical to advance patient care. Since 2012, the molecular profiling trials “MOlecular Screening for CAncer Treatment Optimization” (MOSCATO-01) and “MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification” (MAPPYACTS) have included pediatric and adolescent patients with recurrent or refractory malignancy that underwent on-purpose biopsy or surgical intervention. Whole Exome Sequencing of tumor and normal tissue and RNA Sequencing of tumor tissue have been applied to detect genomic alterations that could lead to an adapted targeted treatment. Furthermore, ancillary studies were associated exploring circulating tumor DNA, the immune contexture of tumors and developing Patient-Derived Xenografts (PDX). The FMG2025 project transfers the molecular profiling of advanced pediatric cancers into a global approach that is now considered standard of care in France. Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientist and physicians in the molecular and clinical molecular tumor boards. Associated ancillary research studies and links to clinical interventional studies remain essential elements of the program to provide clinical, translational and basic research in order to improve scientific knowledge. The program is articulated in two main parts that are closely interacting: FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects that cover the sequencing of tumor and blood samples and provide molecular reports. The clinical study MAPPYACTS 2 that provides clinical and therapeutic discussions of the sequencing results and therapy recommendations via the clinical molecular tumor board reports. It collects molecular and comprehensive clinical data of the patients registered in FMG2025 or equivalent international projects and thereby constitutes the critical link to clinical interventional studies and its sponsors ensuring facilitated access to these trials. It also covers and coordinates ancillary research studies. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Solid tumor and CT DNA Start Date: 2022-09-09 Last Updated: 2023-01-20 Number of Patients: 1800 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT00136591
Title: A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma Study Summary: This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma. Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study. Sponsor: Lymphoma Study Association Intervention: Bortezomib Start Date: 2005-09 Last Updated: 2010-10-26 Number of Patients: 87 Recruitment Status: TERMINATED Condition: Follicular Lymphoma
NCTID: NCT00930891
Title: Bevacizumab in Extensive Small Cell Lung Cancer Study Summary: Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation. Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers. In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Standard Chemotherapy (PCDE or PE) Start Date: 2009-09 Last Updated: 2016-03-10 Number of Patients: 143 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT04765709
Title: Durvalumab and Chemotherapy Induction Followed by Durvalumab and Radiotherapy in Large Volume Stage III NSCLC Study Summary: Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy. The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy. Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab. The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes. BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls. This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed) Start Date: 2021-09-24 Last Updated: 2023-10-19 Number of Patients: 10 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer Stage III
NCTID: NCT00541008
Title: Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer Study Summary: RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. Sponsor: UNICANCER Intervention: sunitinib malate Start Date: 2007-09-05 Last Updated: 2021-02-21 Number of Patients: 92 Recruitment Status: COMPLETED Condition: Kidney Cancer
NCTID: NCT05176691
Title: HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL Study Summary: An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL Sponsor: Hutchmed Intervention: HMPL-760 Start Date: 2022-02-15 Last Updated: 2023-02-21 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: CLL/SLL
NCTID: NCT03625791
Title: Validation of a Genetic Signature to Predict the Development of Sarcomas Study Summary: The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma. Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones. The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy. Sponsor: Centre Georges Francois Leclerc Intervention: blood sample Start Date: 2018-06-01 Last Updated: 2019-10-28 Number of Patients: 60 Recruitment Status: UNKNOWN Condition: Genetic Signature in Development of Sarcomas
NCTID: NCT02094391
Title: Trial of Ipilimumab After Isolated Limb Perfusion, in Patients With Metastases Melanoma Study Summary: Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Ipilimumab Start Date: 2014-03 Last Updated: 2016-06-09 Number of Patients: 4 Recruitment Status: COMPLETED Condition: In-transit Metastases Melanoma Stage IIIB and IIIC
NCTID: NCT05265208
Title: Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer Study Summary: Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (<5mm) margins having a higher risk of recurrence. Selective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics. Given the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC. Sponsor: Center Eugene Marquis Intervention: Capecitabine Start Date: 2022-02-04 Last Updated: 2023-11-13 Number of Patients: 62 Recruitment Status: SUSPENDED Condition: Resectable Intrahepatic Cholangiocarcinoma
NCTID: NCT00028691
Title: Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated. Sponsor: Commissie Voor Klinisch Toegepast Onderzoek Intervention: chlorambucil Start Date: 2002-12 Last Updated: 2013-09-17 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT05070208
Title: Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor Study Summary: Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date. The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification. Sponsor: Acute Leukemia French Association Intervention: NOT PROVIDED Start Date: 2021-09-22 Last Updated: 2021-10-07 Number of Patients: 200 Recruitment Status: UNKNOWN Condition: Acute Myeloblastic Leukemia Core Binding Factor
NCTID: NCT00169208
Title: Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin’s Lymphoma Study Summary: This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin’s lymphoma (NHL). Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2001-04 Last Updated: 2019-08-28 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT02285179
Title: Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen Study Summary: This study is designed as a phase 1 dose escalation study followed by a randomised phase II study. The study will be performed in three different centres: Addenbrooke & Cambridge university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d’Hebron Hospital (Barcelona, Spain). Three to six patients will be followed for one completed cycle of therapy (28 days) and subsequent enrolment of new cohorts will be based on the safety assessment in that first cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alone. Sponsor: The Netherlands Cancer Institute Intervention: GDC-0032 Start Date: 2014-11 Last Updated: 2022-10-12 Number of Patients: 189 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00004179
Title: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rituximab Start Date: 1999-05 Last Updated: 2021-02-15 Number of Patients: 475 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT02292979
Title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma. Study Summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy. Sponsor: The Lymphoma Academic Research Organisation Intervention: Doxorubicin Start Date: 2015-03 Last Updated: 2022-08-19 Number of Patients: 170 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT05705791
Title: Clinical Investigation Evaluating Safety and Efficacy of Selective Intra-arterial 166Holmium Radiation Therapy in Combination With Atezolizumab and Bevacizumab for Non Resectable Hepatocellular Carcinoma Study Summary: The goal of this clinical trial is to evaluate the added value of 166Holmium SIRT to Atezolizumab-Bevacizumab in patients with non resectable HCC. The primary endpoint is the Best Objective Response Rate at 6 months after 166Holmium SIRT according to mRECIST. Participants will be treated by : * Approved first line systemic therapy: Atezolizumab (1200mg Q3W, IV) with Bevacizumab (15mg/kg Q3W, IV) * In combination with 166Holmium selective internal intra-arterial radiation therapy (Quirem Spheres®, the investigational medical device) after a work-up phase considered as “favorable”. Participants will be followed up to 12 months after the first cycle of Atezolizumab and Bevacizumab therapy. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: QuiremSpheres Start Date: 2023-02-07 Last Updated: 2023-02-14 Number of Patients: 33 Recruitment Status: RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT03580408
Title: Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma Study Summary: This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. : * In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12. * In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12. * In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure. Sponsor: The Lymphoma Academic Research Organisation Intervention: Nivolumab Start Date: 2018-08-31 Last Updated: 2022-08-19 Number of Patients: 64 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT00811408
Title: Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy Study Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: carboplatin Start Date: 2008-04 Last Updated: 2010-01-28 Number of Patients: 24 Recruitment Status: UNKNOWN Condition: Cervical Cancer
NCTID: NCT03126591
Title: A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma Study Summary: The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma. Sponsor: Eli Lilly and Company Intervention: Olaratumab Start Date: 2017-07-03 Last Updated: 2023-04-13 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Soft Tissue Sarcoma
NCTID: NCT03052608
Title: A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Study Summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population Sponsor: Pfizer Intervention: Lorlatinib Start Date: 2017-04-27 Last Updated: 2023-06-07 Number of Patients: 296 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT00180791
Title: High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood Study Summary: The purpose of this study is to evaluate the efficacy of the combination of surgery, conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell transplantation and reduced dose radiation therapy in high-risk PNET brain tumors. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Etoposide, carboplatin, melphalan, cisplatin, thiotepa Start Date: 2002-07 Last Updated: 2007-09-18 Number of Patients: 71 Recruitment Status: UNKNOWN Condition: Medulloblastoma
NCTID: NCT00086879
Title: Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme Study Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme. PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: carmustine Start Date: 2004-05 Last Updated: 2017-07-27 Number of Patients: 110 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT02323191
Title: A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors Study Summary: This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment. Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-01-19 Last Updated: 2020-08-27 Number of Patients: 221 Recruitment Status: COMPLETED Condition: Solid Cancers
NCTID: NCT04657991
Title: A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2021-01-15 Last Updated: 2023-11-07 Number of Patients: 624 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT05650879
Title: ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer Study Summary: The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer. Sponsor: Enliven Therapeutics Intervention: ELVN-002 Start Date: 2023-03-20 Last Updated: 2023-11-09 Number of Patients: 178 Recruitment Status: RECRUITING Condition: HER2 Mutant Non-small Cell Lung Cancer
NCTID: NCT04260191
Title: Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma Study Summary: To evaluate the safety and tolerability of AMG 910 in adult subjects, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) Sponsor: Amgen Intervention: AMG 910 Start Date: 2020-06-29 Last Updated: 2022-11-18 Number of Patients: 15 Recruitment Status: COMPLETED Condition: Gastric and Gastroesophageal Junction Adenocarcinoma
NCTID: NCT01701479
Title: Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2) Study Summary: The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young people with primary refractory or relapsed neuroblastoma without intravenous morphine. Sponsor: St. Anna Kinderkrebsforschung Intervention: ch14.18/CHO Start Date: 2012-01 Last Updated: 2020-07-14 Number of Patients: 288 Recruitment Status: UNKNOWN Condition: Neuroblastoma
NCTID: NCT00003979
Title: CHS 828 in Treating Patients With Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: CHS 828 Start Date: 1999-04 Last Updated: 2012-07-11 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT03612791
Title: Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab Study Summary: The primary objective of this randomized phase II trial is to evaluate the clinical benefits of the addition of atezolizumab to standard chemoradiotherapy (CRT) (first given concurrently with CRT, then continued as adjuvant treatment), compared with CRT alone, on investigator-assessed progression-free survival (PFS), as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Atezolizumab Start Date: 2018-08-13 Last Updated: 2022-03-03 Number of Patients: 189 Recruitment Status: RECRUITING Condition: Locally Advanced Cervical Cancer
NCTID: NCT00066391
Title: Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer Study Summary: RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2003-06 Last Updated: 2012-09-24 Number of Patients: NA Recruitment Status: COMPLETED Condition: Penile Cancer
NCTID: NCT04095208
Title: Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study Study Summary: This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab. Sponsor: Institut Bergonié Intervention: Association of Nivolumab + Relatlimab Start Date: 2020-02-27 Last Updated: 2023-02-22 Number of Patients: 67 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma Adult
NCTID: NCT04015739
Title: Tri Association in Patient With Advanced Epithelial Ovarian Cancer in Relapse Study Summary: Assessing the safety and efficacy of the bevacizumab, Olaparib and Durvalumab (MEDI 4736) combination in patient with high grade serous or high grade endometrioid or other high grade epithelial non mucinous ovarian tumor, with at least one previous line of platinum-taxane chemotherapy, and present with platinum resistant disease (PRR) or platinum-sensitive relapse (PSR), whatever the line of chemotherapy given at relapse. Sponsor: ARCAGY/ GINECO GROUP Intervention: Bevacizumab, Olaparib and Durvalumab (MEDI 4736) combination Start Date: 2019-03-01 Last Updated: 2022-08-17 Number of Patients: 74 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Epithelial Ovarian Cancer
NCTID: NCT04322539
Title: A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer Study Summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC. Sponsor: Hutchison Medipharma Limited Intervention: Fruquintinib Start Date: 2020-08-12 Last Updated: 2023-09-14 Number of Patients: 691 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT03875079
Title: A Study To Evaluate Safety And Therapeutic Activity Of RO6874281 In Combination With Pembrolizumab, In Participants With Advanced Or Metastatic Melanoma Study Summary: This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period. Sponsor: Hoffmann-La Roche Intervention: RO6874281 Start Date: 2019-06-24 Last Updated: 2023-03-29 Number of Patients: 83 Recruitment Status: COMPLETED Condition: Metastatic Melanoma
NCTID: NCT04229979
Title: Galinpepimut-S Versus Investigator’s Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 Study Summary: To assess the safety and efficacy of galinpepimut-S (GPS) compared with investigator’s choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2). Sponsor: Sellas Life Sciences Group Intervention: Galinpepimut-S Start Date: 2021-02-08 Last Updated: 2023-02-01 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT05529979
Title: Epione® Post-Market Clinical Follow-up Study Study Summary: Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen Sponsor: Quantum Surgical Intervention: EPIONE® CT-Guided Percutaneous procedures Start Date: 2022-04-21 Last Updated: 2023-08-09 Number of Patients: 55 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer Abdomen
NCTID: NCT00005979
Title: Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer. Sponsor: UNICANCER Intervention: FOLFIRI regimen Start Date: 1998-07-22 Last Updated: 2021-02-17 Number of Patients: NA Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03978039
Title: National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group Study Summary: The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas <math display="block">RESOS</math> / French expert network dedicated to the pathology of sarcomas <math display="block">RREPS</math>), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas <math display="block">NETSARC</math>), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples. Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients’ outcomes. With the financial support of the French National Cancer Institute <math display="block">Institut National du cancer \[INCa</math>). Sponsor: Institut Bergonié Intervention: Chemotherapy Start Date: 2010-01 Last Updated: 2023-07-05 Number of Patients: 20000 Recruitment Status: RECRUITING Condition: Sarcoma
NCTID: NCT06090539
Title: A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas Study Summary: The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma. Sponsor: Bristol-Myers Squibb Intervention: BMS-986458 Start Date: 2023-11-20 Last Updated: 2023-11-21 Number of Patients: 273 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Non-Hodgkin Lymphoma
NCTID: NCT04626479
Title: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) Study Summary: Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-16 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT01480479
Title: Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma Study Summary: This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival. Sponsor: Celldex Therapeutics Intervention: Rindopepimut (CDX-110) with GM-CSF Start Date: 2011-11 Last Updated: 2018-01-16 Number of Patients: 745 Recruitment Status: COMPLETED Condition: Glioblastoma
NCTID: NCT02360579
Title: Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma Study Summary: Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen. Sponsor: Iovance Biotherapeutics, Inc. Intervention: Lifileucel Start Date: 2015-09 Last Updated: 2023-07-12 Number of Patients: 178 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Melanoma
NCTID: NCT03434379
Title: A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma Study Summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-03-15 Last Updated: 2023-10-23 Number of Patients: 558 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT04579679
Title: Open-Label Surufatinib in European Patients With NET Study Summary: This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low to intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumours (NETs). Sponsor: Hutchmed Intervention: Surufatinib Start Date: 2021-08-13 Last Updated: 2023-02-21 Number of Patients: 78 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neuroendocrine Tumours
NCTID: NCT00631371
Title: Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects Study Summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival. Sponsor: Pfizer Intervention: Bevacizumab Start Date: 2008-04 Last Updated: 2016-04-27 Number of Patients: 791 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT00838539
Title: Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors Study Summary: The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination. Sponsor: Puma Biotechnology, Inc. Intervention: Neratinib Start Date: 2009-04 Last Updated: 2018-09-18 Number of Patients: 63 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT03895671
Title: PONAZA : A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS Study Summary: This project is strategy aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis. The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis. Sponsor: Versailles Hospital Intervention: Ponatinib Start Date: 2019-06-19 Last Updated: 2020-08-07 Number of Patients: 40 Recruitment Status: RECRUITING Condition: CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE
NCTID: NCT03441139
Title: Efficacy of Cryotherapy Combined or Not With Analgesics in Uncontrolled Painful Musculoskeletal Metastasis Study Summary: The primary objective of this trial is to compare the efficacy of 2 analgesic strategies, based on percutaneous cryotherapy plus medical supportive care versus medical supportive care alone in the treatment of cancer patients with painful musculoskeletal metastasis. Sponsor: Centre Leon Berard Intervention: Cryotherapy + Medical analgesics Start Date: 2018-07-19 Last Updated: 2021-10-19 Number of Patients: 18 Recruitment Status: TERMINATED Condition: Musculoskeletal Pain
NCTID: NCT03318939
Title: Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation Study Summary: This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7). Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Poziotinib Start Date: 2017-10-13 Last Updated: 2023-02-15 Number of Patients: 603 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: NSCLC
NCTID: NCT04524871
Title: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) Study Summary: This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-11-02 Last Updated: 2023-11-13 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Advanced Liver Cancers
NCTID: NCT00978471
Title: Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma Study Summary: Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic. Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months. Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE. According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year. At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE. Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed. These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse. Sponsor: Centre Leon Berard Intervention: Thiotepa Start Date: 2009-07 Last Updated: 2019-05-17 Number of Patients: 44 Recruitment Status: COMPLETED Condition: Osteosarcoma
NCTID: NCT05476939
Title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 Study Summary: The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol). It is a multicenter, randomized open-label phase-3 controlled trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls. Two treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until disease progression, unacceptable toxicity or consent withdrawal. The final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Everolimus Start Date: 2022-09-29 Last Updated: 2023-01-30 Number of Patients: 368 Recruitment Status: RECRUITING Condition: Diffuse Intrinsic Pontine Glioma
NCTID: NCT01764009
Title: Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma Study Summary: The objective of the present trial is: * to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. * to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP * to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP Sponsor: Onxeo Intervention: naked DNA coding for protein AMEP Start Date: 2012-06 Last Updated: 2015-09-11 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Melanoma
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT04526106
Title: REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Study Summary: This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3). Sponsor: Relay Therapeutics, Inc. Intervention: RLY-4008 Start Date: 2020-09-02 Last Updated: 2023-10-25 Number of Patients: 550 Recruitment Status: RECRUITING Condition: FGFR2 Amplification
NCTID: NCT02372006
Title: Trial of Afatinib in Pediatric Tumours Study Summary: Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: # Dose finding part to determine the MTD # Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types Sponsor: Boehringer Ingelheim Intervention: afatinib Start Date: 2015-04-29 Last Updated: 2021-03-04 Number of Patients: 56 Recruitment Status: COMPLETED Condition: Neuroectodermal Tumors
NCTID: NCT02343406
Title: Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas Study Summary: This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population. Sponsor: AbbVie Intervention: Depatuxizumab mafodotin Start Date: 2015-02-17 Last Updated: 2020-05-22 Number of Patients: 266 Recruitment Status: COMPLETED Condition: Glioblastoma
NCTID: NCT03466827
Title: Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma Study Summary: The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients). There are two study arms: Arm A: Thymoma * Stage 1: 15 patients * Stage 2: 10 patients Arm B: Thymic carcinoma * Stage 1: 15 patients * Stage 2: 10 patients Sponsor: Morten Mau-Soerensen Intervention: Selinexor Start Date: 2017-10-12 Last Updated: 2018-03-15 Number of Patients: 25 Recruitment Status: UNKNOWN Condition: Thymoma
NCTID: NCT03416179
Title: A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia Study Summary: Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population). Sponsor: Pfizer Intervention: glasdegib Start Date: 2018-04-20 Last Updated: 2023-04-21 Number of Patients: 730 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT01870609
Title: Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Study Summary: This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study. Sponsor: Verastem, Inc. Intervention: defactinib (VS-6063) Start Date: 2013-09 Last Updated: 2017-01-30 Number of Patients: 344 Recruitment Status: TERMINATED Condition: Malignant Pleural Mesothelioma
NCTID: NCT05168839
Title: Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage Study Summary: Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC. The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer. The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision. A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited. In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes. Sponsor: Centre Hospitalier Universitaire de Besancon Intervention: FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG). Start Date: 2022-09-26 Last Updated: 2023-04-06 Number of Patients: 1010 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT04582539
Title: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma Study Summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia. Sponsor: Incyte Corporation Intervention: INCB000928 Start Date: 2021-08-19 Last Updated: 2023-10-23 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT00949039
Title: Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer Study Summary: Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery). Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer. The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Isolated pelvis perfusion Start Date: 2009-02 Last Updated: 2015-03-12 Number of Patients: 101 Recruitment Status: COMPLETED Condition: Gynaecologic or Digestive Pelvic Cancer
NCTID: NCT01011439
Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Study Summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. Sponsor: Tiziana Life Sciences LTD Intervention: Milciclib Maleate Start Date: 2010-02-22 Last Updated: 2019-02-06 Number of Patients: 72 Recruitment Status: TERMINATED Condition: Thymic Carcinoma
NCTID: NCT04463771
Title: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. Study Summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents. Sponsor: Incyte Corporation Intervention: retifanlimab Start Date: 2021-01-26 Last Updated: 2023-10-26 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT03906071
Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Study Summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. Sponsor: Mirati Therapeutics Inc. Intervention: Nivolumab Start Date: 2019-07-15 Last Updated: 2023-10-24 Number of Patients: 532 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT03556839
Title: Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix Study Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment. Sponsor: Grupo Español de Investigación en Cáncer de Ovario Intervention: Atezolizumab Start Date: 2018-09-25 Last Updated: 2023-09-13 Number of Patients: 404 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma of the Cervix, Stage IVB
NCTID: NCT01702571
Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2012-11-27 Last Updated: 2022-04-04 Number of Patients: 2185 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01805271
Title: Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy Study Summary: A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus on patients with ER+/Her2-negative breast cancer, with ≥4N+, 30% had relapsed at 5 years, emphasizing the need for new drugs in this setting (PACS01 data, UNICANCER internal data). Strong evidence suggests that cross-talk between the phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway and ER signaling is linked to hormone resistance in breast cancer patients. In the present study, we plan to evaluate the benefit from adding everolimus to standard endocrine treatments after three years of treatment for patient ER+/HER2- at high risk of relapse due to high nodes involvement (≥4) and/or persistent node involvement after neo-adjuvant chemotherapy. Genomic signatures have emerged during the last 10 years as a new and additive means to evaluate more precisely long term prognosis, and in some instances the amount of benefit from chemotherapy or endocrine therapy in the adjuvant setting. Therefore, the UNIRAD study can be proposed to patients with 1-3 positive lymph nodes at primary surgery and a high risk of relapse with the EndoPredict test. This study is a unique opportunity to prove the efficacy of everolimus in adjuvant setting. The study could be practice changing in case of positive results and could allow improving outcome of breast cancer patients presenting high risk of metastatic relapse. Sponsor: UNICANCER Intervention: Everolimus Start Date: 2013-03 Last Updated: 2023-03-02 Number of Patients: 1278 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Primary Non-metastatic Breast Cancer
NCTID: NCT00303771
Title: Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer. PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer . Sponsor: Federation Francophone de Cancerologie Digestive Intervention: fluorouracil Start Date: 2003-06 Last Updated: 2016-05-30 Number of Patients: 282 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT01578239
Title: A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours Study Summary: This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment. Sponsor: Advanced Accelerator Applications Intervention: Octreotide LAR Start Date: 2012-09-06 Last Updated: 2022-04-04 Number of Patients: 231 Recruitment Status: COMPLETED Condition: Carcinoid Tumor of the Small Bowel
NCTID: NCT01714739
Title: A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors Study Summary: To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors. Sponsor: Bristol-Myers Squibb Intervention: Lirilumab Start Date: 2012-10-07 Last Updated: 2023-02-02 Number of Patients: 337 Recruitment Status: COMPLETED Condition: CANCER,NOS
NCTID: NCT03866239
Title: A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma Study Summary: CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part. Sponsor: Hoffmann-La Roche Intervention: Obinutuzumab Start Date: 2019-05-07 Last Updated: 2023-10-26 Number of Patients: 47 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer
NCTID: NCT01763671
Title: Paclitaxel-bevacizumab in Advanced Lung Cancer Study Summary: The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel. Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage. Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Docetaxel Start Date: 2013-05 Last Updated: 2023-03-14 Number of Patients: 166 Recruitment Status: COMPLETED Condition: Non-squamous Non-small Cell Lung Cancer
NCTID: NCT02794571
Title: Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors Study Summary: This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care. Sponsor: Genentech, Inc. Intervention: Atezolizumab Start Date: 2016-05-23 Last Updated: 2023-09-13 Number of Patients: 518 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced/Metastatic Tumors
NCTID: NCT04195750
Title: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) Study Summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2020-02-27 Last Updated: 2022-08-01 Number of Patients: 736 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT05800275
Title: Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease Study Summary: The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy. Sponsor: UNICANCER Intervention: Tucatinib Oral Tablet Start Date: 2023-11 Last Updated: 2023-11-02 Number of Patients: 30 Recruitment Status: NOT_YET_RECRUITING Condition: Leptomeningeal Metastasis
NCTID: NCT05936359
Title: A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms Study Summary: This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms. Sponsor: Incyte Corporation Intervention: INCA033989 Start Date: 2023-09-25 Last Updated: 2023-11-09 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Myeloproliferative Neoplasms
NCTID: NCT00181168
Title: Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer Study Summary: The purpose of this study is to determine <math display="block">for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level</math> whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection) will be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The study will also determine if this information will significantly alter the therapeutic approach in some patients. Sponsor: Johns Hopkins University Intervention: Euthyroid Group Start Date: 2001-03 Last Updated: 2018-11-02 Number of Patients: 63 Recruitment Status: COMPLETED Condition: Thyroid Cancer
NCTID: NCT04069468
Title: Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC) Study Summary: The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France. Sponsor: Boston Scientific Corporation Intervention: TheraSphere Start Date: 2019-03-13 Last Updated: 2023-11-18 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT02601950
Title: A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma Study Summary: This study will include participants with various types of cancer known as soft-tissue sarcomas. Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments. Soft tissue cancers are rare and can occur almost anywhere in the body. Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment). Sponsor: Epizyme, Inc. Intervention: Tazemetostat Start Date: 2015-12-22 Last Updated: 2023-10-26 Number of Patients: 267 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Malignant Rhabdoid Tumors (MRT)
NCTID: NCT05386550
Title: Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) Study Summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2022-10-06 Last Updated: 2023-11-02 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT04934475
Title: MInimal Residual Disease Adapted Strategy Study Summary: IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5). Sponsor: Intergroupe Francophone du Myelome Intervention: Isatuximab Start Date: 2021-12-08 Last Updated: 2023-02-28 Number of Patients: 716 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT05912075
Title: Preoperative Radiotherapy And ASTX660 in Rectum Cancer Study Summary: Compare two arms: * Chemotherapy followed by tolinapant (ASTX660) in combination with Long-Course Radio Chemotherapy (LCRT), and * Tolinapant (ASTX660) in combination with Short-Course Radiotherapy (SCRT) followed by chemotherapy For each patient, the treatment arm will be allocated on the following basis: patients will be allocated to the chemotherapy followed by LCRT arm unless they present at least one of the following criteria: contraindication to receive mFOLFIRINOX (including intolerance to irinotecan and UGT1A1*28 polymorphism), age > 75, general condition incompatible with the radiotherapy schedule of LCRT. In such case, patients will be allocated to the SCRT arm. Tolinapant (ASTX660) will be administered orally once a day for 7 consecutive days every other week during 10 weeks (One week On / One week Off during 10 weeks). Both treatment arms will have a dose escalation part to determine the MTD and/or RP2D, followed by an expansion part where up to 21 subjects will be dosed at the RP2D. Both arms will enroll simultaneously. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: mFOLFIRINOX Start Date: 2023-07-01 Last Updated: 2023-06-22 Number of Patients: 78 Recruitment Status: NOT_YET_RECRUITING Condition: Locally-advanced Rectal Cancer
NCTID: NCT00020839
Title: Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 2001-04 Last Updated: 2012-09-24 Number of Patients: 23 Recruitment Status: TERMINATED Condition: Melanoma (Skin)
NCTID: NCT05153239
Title: Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON) Study Summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator’s Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line. Sponsor: PharmaMar Intervention: Irinotecan Start Date: 2022-07-22 Last Updated: 2023-11-27 Number of Patients: 705 Recruitment Status: RECRUITING Condition: Relapsed Small Cell Lung Cancer
NCTID: NCT00162708
Title: Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC Study Summary: Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID) Start Date: 1996-07 Last Updated: 2005-09-13 Number of Patients: 120 Recruitment Status: COMPLETED Condition: Oropharynx Cancer
NCTID: NCT00988208
Title: Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer Study Summary: The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-11-11 Last Updated: 2018-04-04 Number of Patients: 1059 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04992949
Title: Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm Study Summary: The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research. The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival. CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy. Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT). Sponsor: French Innovative Leukemia Organisation Intervention: CPX-351 Start Date: 2022-03-23 Last Updated: 2022-10-18 Number of Patients: 42 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT03517449
Title: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician’s Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) Study Summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician’s choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician’s choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician’s choice. Sponsor: Eisai Inc. Intervention: Pembrolizumab Start Date: 2018-06-11 Last Updated: 2023-10-18 Number of Patients: 827 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT01802749
Title: Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer Study Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone. Sponsor: National Cancer Institute, Naples Intervention: Bevacizumab Start Date: 2013-11 Last Updated: 2023-03-24 Number of Patients: 406 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Recurrent Ovarian Cancer
NCTID: NCT03744468
Title: Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors Study Summary: This is an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of BGB-A425 and/or LBL-007 with tislelizumab. Sponsor: BeiGene Intervention: BGB-A425 Start Date: 2018-11-13 Last Updated: 2023-09-28 Number of Patients: 358 Recruitment Status: RECRUITING Condition: Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2
NCTID: NCT00169468
Title: Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma Study Summary: The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged from 18 to 80 years The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test. The other objective is to evaluate the toxicity Sponsor: Lymphoma Study Association Intervention: Rituximab -CHOP plus Velcade Start Date: 2005-01 Last Updated: 2018-08-23 Number of Patients: 48 Recruitment Status: COMPLETED Condition: B Cell Lymphoma
NCTID: NCT01466868
Title: Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma Study Summary: The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in patients with relapsed or refractory diffuse large B cell lymphoma. Sponsor: Centre Leon Berard Intervention: MK2206 Start Date: 2011-11 Last Updated: 2014-07-10 Number of Patients: 22 Recruitment Status: TERMINATED Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT01433068
Title: NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity Study Summary: RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor. PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy. Sponsor: Nanobiotix Intervention: NBTXR3 Start Date: 2011-10 Last Updated: 2020-10-06 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Adult Soft Tissue Sarcoma
NCTID: NCT00619268
Title: Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma Study Summary: The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer. Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®. Sponsor: Centre Leon Berard Intervention: Temsirolimus Start Date: 2008-02 Last Updated: 2013-02-15 Number of Patients: 160 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT00552149
Title: Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin Study Summary: A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Gemox, Cetuximab Start Date: 2007-10 Last Updated: 2012-06-13 Number of Patients: 150 Recruitment Status: COMPLETED Condition: Advanced Biliary Cancer
NCTID: NCT00349505
Title: Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma Study Summary: Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated by surgery and a total of 6 cycles of platinum based chemotherapy. A second look operation is performed after treatment; during this second look secondary cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal disease is obseved an intraperitoneal chemotherapy is achieve Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: hyper thermic chemo + surgery Start Date: 2004-09 Last Updated: 2006-10-06 Number of Patients: 67 Recruitment Status: UNKNOWN Condition: Epithelial Ovarian Carcinoma
NCTID: NCT01945775
Title: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) Study Summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. Sponsor: Pfizer Intervention: talazoparib Start Date: 2013-10-14 Last Updated: 2022-01-20 Number of Patients: 431 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT02311959
Title: Therapeutic Nipple Sparing Mastectomy. Study Summary: This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test. The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates. 450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year). All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse). The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction. After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate. An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study. A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM. Data will be collected over a 3 months period after surgery. Sponsor: Institut Claudius Regaud Intervention: Nipple sparing mastectomy Start Date: 2015-02-09 Last Updated: 2023-08-03 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01567475
Title: The Combination of Rad001 and Rituximab In Patients With Non-hodgkin’s Lymphomas Study Summary: This study is an open label, multicenter study with two phases: * Phase I is a dose escalation study of RAD001 in combination with one injection of Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive non-Hodgkin’s lymphomas to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD). The purpose of the study is to assess the feasibility of the combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug interaction (DDI). * Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination at the RP2D in patients with lymphomas. Patients with lymphomas will be treated at the RP2D established during phase I and evaluated for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR) and stable disease (SD), and time to progression using the IWG criteria for treatment response. Induction therapy will follow the same schedule than during the phase I study. Maintenance therapy: Monthly cycles for up to 2 years with: * Daily RAD001 at the same dose than during induction therapy. * Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual maintenance schedule for Rituximab. Response to therapy will be assessed between day 42 and day 49, then every two months. Sponsor: The Lymphoma Academic Research Organisation Intervention: Everolimus and rituximab Start Date: 2011-12 Last Updated: 2016-03-15 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphomas
NCTID: NCT05533775
Title: A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma Study Summary: The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL). Sponsor: Hoffmann-La Roche Intervention: Obinutuzumab Start Date: 2022-11-16 Last Updated: 2023-11-18 Number of Patients: 65 Recruitment Status: RECRUITING Condition: Mature B-Cell Non-Hodgkin Lymphoma
NCTID: NCT00486759
Title: A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma Study Summary: This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin <math display="block">doxorubicin</math>, Oncovin <math display="block">vincristine</math>, prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles). Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2007-07-26 Last Updated: 2017-07-25 Number of Patients: 787 Recruitment Status: TERMINATED Condition: B-cell Lymphoma
NCTID: NCT02912949
Title: A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) Study Summary: This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy) Sponsor: Merus N.V. Intervention: zenocutuzumab (MCLA-128) Start Date: 2015-01 Last Updated: 2022-12-27 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Solid Tumours Harboring NRG1 Fusion
NCTID: NCT00878709
Title: Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer Study Summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2009-07-09 Last Updated: 2021-06-11 Number of Patients: 2840 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01688206
Title: A Study of Vanucizumab (RO5520985) Alone or in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors Study Summary: This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose <math display="block">RP2D</math>), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab [TECENTRIQ] Start Date: 2012-10-31 Last Updated: 2018-10-05 Number of Patients: 132 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT05623397
Title: A Deep Learning Method to Evaluate QT on Ribociclib Study Summary: “Deep-learning” is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for example, the measurement of QTc). Unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. With the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. The investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ECGs (.xml) into a measure of QTc comparable to those respecting the highest standards concerning reproducibility. The main purpose of this trial is to study the performance of our DL-AI model for QTc measurement (vs. best standards of QTc measurements, TCM) applied to the recommended ECG monitoring following ribociclib prescription for breast cancer patients in routine clinical care. The investigators will acquire ECG with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 Htz) to determine if they’ll be equally performant versus 12-lead acquisition machine to evaluate QTc in this setting. Sponsor: CMC Ambroise Paré Intervention: Acquisition of a digitized ECG by four modalities within 20 minutes Start Date: 2023-07-28 Last Updated: 2023-09-06 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03395197
Title: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Study Summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. Sponsor: Pfizer Intervention: Talazoparib with enzalutamide Start Date: 2017-12-18 Last Updated: 2023-08-02 Number of Patients: 1125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: mCRPC
NCTID: NCT01946867
Title: NBTXR3 and Radiation Therapy in Treating Patients With Locally Advanced SCC of the Oral Cavity or Oropharynx Study Summary: RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions. The incidence of Head and Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population as recorded by the Surveillance, Epidemiology, and End Results registries in the United States. Regarding the therapeutic strategies, the association of radiotherapy with chemotherapy or biologics has demonstrated significant improvement of outcomes with the drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell killing and complete tumor shrinkage allowing a definitive treatment and preservation of local structures and functions in patients older 65 years, who cannot receive cisplatin. Sponsor: Nanobiotix Intervention: NBTXR3 activated by IMRT Start Date: 2014-01-03 Last Updated: 2022-12-29 Number of Patients: 75 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Cancer
NCTID: NCT04068597
Title: Study to Evaluate CCS1477 in Haematological Malignancies Study Summary: A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome. Sponsor: CellCentric Ltd. Intervention: CCS1477 Start Date: 2019-08-09 Last Updated: 2023-11-09 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Haematological Malignancy
NCTID: NCT04778397
Title: Study of Magrolimab in Combination With Azacitidine Versus Physician’s Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated Study Summary: The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML). Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2021-07-01 Last Updated: 2023-10-11 Number of Patients: 346 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT05293197
Title: Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients Study Summary: Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin. Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: SonoCloud® (9 transducers) Start Date: 2023-02-06 Last Updated: 2023-10-16 Number of Patients: 24 Recruitment Status: RECRUITING Condition: Malignant Brain Tumor
NCTID: NCT01556490
Title: Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer Study Summary: The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere. Sponsor: Boston Scientific Corporation Intervention: TheraSphere Start Date: 2012-03 Last Updated: 2023-11-08 Number of Patients: 526 Recruitment Status: COMPLETED Condition: Unresectable Hepatocellular Carcinoma
NCTID: NCT03833167
Title: Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630) Study Summary: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab 400 mg Start Date: 2019-04-01 Last Updated: 2023-11-27 Number of Patients: 430 Recruitment Status: RECRUITING Condition: Carcinoma, Squamous Cell
NCTID: NCT03733990
Title: A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS) Study Summary: This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity. The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator’s existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients. Sponsor: Faron Pharmaceuticals Ltd Intervention: FP-1305 (bexmarilimab) Start Date: 2018-12-03 Last Updated: 2023-11-27 Number of Patients: 216 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT02013297
Title: Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics) Study Summary: The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors. Sponsor: Centre Leon Berard Intervention: SBRT treatment Start Date: 2013-12-03 Last Updated: 2022-03-08 Number of Patients: 61 Recruitment Status: COMPLETED Condition: Brain Metastasis
NCTID: NCT05144997
Title: Lorlatinib Continuation Study Study Summary: The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention Sponsor: Pfizer Intervention: Lorlatinib Start Date: 2021-12-28 Last Updated: 2023-08-08 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Non-Small-Cell Lung Cancer
NCTID: NCT02147990
Title: Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer Study Summary: The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them. Sponsor: Clovis Oncology, Inc. Intervention: Rociletinib Start Date: 2014-06-16 Last Updated: 2020-08-12 Number of Patients: 318 Recruitment Status: TERMINATED Condition: Non-small Cell Lung Cancer
NCTID: NCT00626990
Title: Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 2007-12 Last Updated: 2023-09-11 Number of Patients: 751 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Brain and Central Nervous System Tumors
NCTID: NCT02173990
Title: Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR). Study Summary: The PULSAR trial is an international, investigator-initiated, single arm open-label phase II study. The aim of this study is to measure the clinical activity of the combination FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer, and treated with a FOLFIRI-aflibercept regimen as first line treatment. Sponsor: Centre Oscar Lambret Intervention: Aflibercept-FOLFIRI Start Date: 2014-07 Last Updated: 2021-10-20 Number of Patients: 40 Recruitment Status: TERMINATED Condition: Metastatic Colorectal Cancer
NCTID: NCT01177397
Title: Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma Study Summary: The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials. Sponsor: Celgene Intervention: CC-223 Start Date: 2010-07-20 Last Updated: 2022-12-13 Number of Patients: 226 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT03568656
Title: Study to Evaluate CCS1477 in Advanced Tumours Study Summary: A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours. Sponsor: CellCentric Ltd. Intervention: CCS1477 Start Date: 2018-07-23 Last Updated: 2023-09-15 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Metastatic Castration-Resistant Prostate Cancer
NCTID: NCT01804790
Title: Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer Study Summary: National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer. Sponsor: UNICANCER Intervention: mFolfirinox Start Date: 2012-01 Last Updated: 2023-08-31 Number of Patients: 461 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer of the Rectum
NCTID: NCT04809467
Title: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) Study Summary: The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-09-16 Last Updated: 2023-08-08 Number of Patients: 54 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT05258383
Title: Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests Study Summary: In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses. The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient’s organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: 3D maps of physical doses Start Date: 2023-05-15 Last Updated: 2023-04-18 Number of Patients: 320 Recruitment Status: NOT_YET_RECRUITING Condition: Lung Neoplasm
NCTID: NCT02489695
Title: Axitinib in1st Line Treatment for Patients With Advanced or Metastatic Papillary Renal Cell Carcinoma Study Summary: Multicenter, single arm, phase II study using a A’Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment. Sponsor: Centre Leon Berard Intervention: Axitinib Start Date: 2015-10 Last Updated: 2022-09-06 Number of Patients: 44 Recruitment Status: COMPLETED Condition: Papillary Renal Cell Carcinoma
NCTID: NCT05781295
Title: Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology Study Summary: Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study. Sponsor: Institut Curie Intervention: TaurolockTM Start Date: 2023-10 Last Updated: 2023-10-02 Number of Patients: 148 Recruitment Status: NOT_YET_RECRUITING Condition: Children
NCTID: NCT03148795
Title: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone). Sponsor: Pfizer Intervention: Talazoparib Start Date: 2017-07-04 Last Updated: 2023-05-10 Number of Patients: 128 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03924895
Title: Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) Study Summary: This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone. With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-24 Last Updated: 2023-11-27 Number of Patients: 857 Recruitment Status: RECRUITING Condition: Urinary Bladder Cancer, Muscle-invasive
NCTID: NCT02997995
Title: Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure Study Summary: This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane. Sponsor: UNICANCER Intervention: Immune-attractant Start Date: 2017-02-15 Last Updated: 2020-09-30 Number of Patients: 61 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03108495
Title: Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma Study Summary: Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma Sponsor: Iovance Biotherapeutics, Inc. Intervention: LN-145 Start Date: 2017-06-22 Last Updated: 2023-09-13 Number of Patients: 189 Recruitment Status: RECRUITING Condition: Cervical Carcinoma
NCTID: NCT02890095
Title: Persistent Organic Pollutants and Breast Cancers (POPCASE) Study Summary: Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world . However, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes). Thus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought). Sponsor: Institut Cancerologie de l’Ouest Intervention: Breast cancer surgery Start Date: 2016-01 Last Updated: 2023-02-22 Number of Patients: 800 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT05568095
Title: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body Study Summary: This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. Sponsor: Arcus Biosciences, Inc. Intervention: Domvanalimab Start Date: 2022-11-21 Last Updated: 2023-11-15 Number of Patients: 970 Recruitment Status: RECRUITING Condition: Advanced Upper Gastrointestinal Tract Adenocarcinoma
NCTID: NCT03345095
Title: A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma Study Summary: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT –>TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT –>TMZ, a phase III study is considered essential to establishing its impact on overall survival. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Marizomib Start Date: 2018-07-26 Last Updated: 2023-05-24 Number of Patients: 749 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Newly Diagnosed Glioblastoma
NCTID: NCT05665595
Title: A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) Study Summary: The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Start Date: 2023-01-19 Last Updated: 2023-11-24 Number of Patients: 1560 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT03053596
Title: LifePearl Anthracyclin Registry in Selective Chemo-Embolization of Patients With Unresectable HCC (PARIS Registry) Study Summary: The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment. Sponsor: Terumo Europe N.V. Intervention: DEB-TACE using anthracyclin loaded LifePearl™ Start Date: 2016-11 Last Updated: 2020-01-27 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Hepatocellular Carcinoma
NCTID: NCT05180695
Title: HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas Study Summary: This trial is a two-step Phase I/II study comprising: Part 1: A dose escalation part with the aim to assess the safety of the proposed combination (N= up to 30 patients). In the dose escalation part, eligible patients will be treated with a fixed dose of pazopanib and escalating doses of HDM201. Part 2: An extension part to collect preliminary data about the clinical activity of the proposed combination according to the 6M-PFR. Sponsor: Centre Leon Berard Intervention: Pazopanib Start Date: 2022-04-15 Last Updated: 2023-09-28 Number of Patients: 58 Recruitment Status: RECRUITING Condition: Advanced Soft-tissue Sarcoma
NCTID: NCT00162695
Title: Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood Study Summary: Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial. IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery. The study was powered to detect 10% difference in 3 year OS. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Ifosfamide, oncovin, actinomycine D, epirubicine, carboplatinum, etoposide Start Date: 1995-07 Last Updated: 2005-09-13 Number of Patients: 400 Recruitment Status: TERMINATED Condition: Rhabdomyosarcoma
NCTID: NCT03732495
Title: Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas Study Summary: This study evaluates the combination of lenvatinib with denosumab in bone-predominant metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas. All patients will receive this combination of treatments. Sponsor: Centre Leon Berard Intervention: Lenvatinib + Denosumab Start Date: 2019-07-26 Last Updated: 2022-03-29 Number of Patients: 35 Recruitment Status: UNKNOWN Condition: Thyroid Cancer Metastatic
NCTID: NCT02268695
Title: Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC Study Summary: This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Cisplatin Start Date: 2014-10-10 Last Updated: 2022-08-23 Number of Patients: 541 Recruitment Status: COMPLETED Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT00722553
Title: Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder Study Summary: The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body). Sponsor: Acrotech Biopharma Inc. Intervention: Pralatrexate Injection Start Date: 2008-07 Last Updated: 2019-12-17 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Carcinoma, Transitional Cell
NCTID: NCT01057953
Title: Oligogenic Determinism of Colorectal Cancer Study Summary: The majority of the clinical situations suggestive of an increased genetic risk for colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC (familial aggregation, early age of tumour onset, development of multiple primary CRC) is due to the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, but whose combination results into high risk. This study, which will be both retrospective and prospective, is an association study that will compare frequencies of selected genetic variations, alone or in combination, between patients (cases) whose clinical presentation is suggestive of an increased genetic risk but who do not present a known Mendelian form of CRC, and controls, in order to assess associations of these variations with non-Mendelian genetic forms of CRC. The inclusion criteria will be: CRC in two first degree relatives, one being diagnosed before 61 years of age; or CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years of age; or multiple primary CRCs in the same individual, the first being diagnosed before 61 years of age The exclusion criteria will be: Lynch syndrome, adenomatous polyposis and hamartomatous polyposis. The genetic variations which will be analyzed will include (i) SNPs detected by GWAS and associated to CRC. (ii) Risk factors corresponding to functional polymorphisms within candidate genes. (iii) Imbalance of the TGFbR1 allelic expression. Sample sizes were calculated to obtain 80% power for an odds ratio of 2.5 since the aim of this study is to determine genetic variations conferring a moderate risk. In order to cover all these possibilities and to have reasonable even for the genetic variations with low frequency below 0.03 or high frequency above 0.90, the target sample size was set at 700 cases and 350 controls. The recruitment of patients will be performed at the national level by the cancer genetics departments ensuring a correct evaluation of the personal and familial history and the French molecular diagnosis laboratories network ensuring in routine the analysis of the main genes involved in CRC. The control population will be composed of healthy subjects of Caucasian origin between 45 and 60 years of age, without personal or familial history among their first-degree relatives of colorectal tumours. Demonstration that the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, results into high risk would allow to base, in selected families, the evaluation of risk in relatives and indication of colonoscopy on the analysis of gene variants the combination of which would confer a high risk. This study will confirm or invalidate the contribution of aTGFbR1 allelic expression imbalance in the determinism of early-onset CRC and familial aggregation of CRC. The demonstration of the involvement in CRC genetic variations with strong effect of specific combinations should be of interest for our general understanding of the molecular basis of CRC. Sponsor: University Hospital, Rouen Intervention: Blood drawn Start Date: 2010-01 Last Updated: 2013-10-16 Number of Patients: 1550 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT00094653
Title: MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma Study Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response <math display="block">PR/CR</math>); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379. Sponsor: Bristol-Myers Squibb Intervention: MDX-010 (anti-CTLA4) monoclonal antibody Start Date: 2004-09 Last Updated: 2011-07-11 Number of Patients: 1783 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT02606461
Title: Selinexor in Advanced Liposarcoma Study Summary: This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo). Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2016-01-04 Last Updated: 2023-01-23 Number of Patients: 342 Recruitment Status: COMPLETED Condition: Dedifferentiated Liposarcoma
NCTID: NCT02885753
Title: Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver Study Summary: Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival. The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance. In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Oxaliplatin intravenous Start Date: 2016-12 Last Updated: 2023-08-18 Number of Patients: 348 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT02516553
Title: BI 894999 First in Human Dose Finding Study in Advanced Malignancies Study Summary: This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carcinoma can also participate. No standard treatment exists for this rare and aggressive form of cancer. The purpose of this study is to find out the highest dose of BI 894999 that people can tolerate. BI 894999 is tested for the first time in humans. Participants take tablets once daily. The study also tests whether participants can tolerate BI 894999 better when taken continuously or with breaks in between. Participants can stay in the study as long as they benefit from the treatment and can tolerate it. The doctors also regularly check the general health of the participants. Sponsor: Boehringer Ingelheim Intervention: BI 894999 Start Date: 2015-07-08 Last Updated: 2021-12-06 Number of Patients: 174 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT00864253
Title: A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma Study Summary: The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma. Sponsor: Celgene Intervention: ABI-007 Start Date: 2009-04-23 Last Updated: 2019-10-30 Number of Patients: 529 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT04193553
Title: Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure Study Summary: The primary objective is to compare the efficacy of lenvatinib plus Best Supportive Care versus Placebo plus Best Supportive Care in the treatment of patients with advanced GIST, after failure of imatinib and sunitinib. Sponsor: Centre Leon Berard Intervention: Lenvatinib Start Date: 2020-01-17 Last Updated: 2023-03-29 Number of Patients: 74 Recruitment Status: RECRUITING Condition: Gastro Intestinal Stromal Tumour
NCTID: NCT00794261
Title: Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma Study Summary: The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months. The number of patients required in this multicentric and prospective study is 150 (13 participating centers). This is a phase II, controlled, randomized, non comparative and open-label multicentric study. Sponsor: Centre Leon Berard Intervention: Injection of Pegfilgrastim Start Date: 2008-09 Last Updated: 2010-07-08 Number of Patients: 150 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT02591095
Title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer Study Summary: ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer. Sponsor: Centre Francois Baclesse Intervention: ABT-263 Start Date: 2016-01 Last Updated: 2019-03-19 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Platinum-resistant or Refractory Ovarian Cancer
NCTID: NCT00049595
Title: Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 2002-08 Last Updated: 2023-11-09 Number of Patients: 552 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT02272595
Title: Rational Therapeutics Based on Matched Tumor and Normal Tissue Study Summary: The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you. This is an investigational study. Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson. Sponsor: M.D. Anderson Cancer Center Intervention: Treatment Based on Genetic Mutation Start Date: 2014-11-04 Last Updated: 2022-02-15 Number of Patients: 3 Recruitment Status: COMPLETED Condition: Advanced Cancers
NCTID: NCT02784795
Title: A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Study Summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors. Sponsor: Eli Lilly and Company Intervention: LY3039478 Start Date: 2016-11-04 Last Updated: 2020-08-17 Number of Patients: 94 Recruitment Status: COMPLETED Condition: Solid Tumor
NCTID: NCT00056095
Title: Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer. Sponsor: UNICANCER Intervention: therapeutic allogeneic lymphocytes Start Date: 2002-11-04 Last Updated: 2021-02-24 Number of Patients: 57 Recruitment Status: COMPLETED Condition: Kidney Cancer
NCTID: NCT00417495
Title: Sentinel Lymph Node Technique in Multifocal Breast Cancer Study Summary: The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer Sponsor: Centre Oscar Lambret Intervention: Sentinel Lymph Node Technique Start Date: 2006-03 Last Updated: 2016-01-06 Number of Patients: 216 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03386162
Title: SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer Study Summary: SAFIR PI3K is an open-label multicenter phase II randomized trial, comparing alpelisib plus fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HR+/Her2- metastatic breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line chemotherapy. The primary objective is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who do not present a progressive disease after 6-8 cycles of chemotherapy. Sponsor: UNICANCER Intervention: Alpelisib Start Date: 2018-03-15 Last Updated: 2022-11-28 Number of Patients: 31 Recruitment Status: TERMINATED Condition: Breast Cancer, PI3K, Alpelisib
NCTID: NCT05296746
Title: Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer Study Summary: This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole. This study aims to evaluate whether chemotherapy could be avoided for initial high-risk clinicopathological breast cancer patients that are converted to low genomic risk assessed by Risk of Recurrence-low (ROR-low) at 6 months of letrozole - ribociclib neoadjuvant treatment by continuing with this treatment in adjuvant setting. Sponsor: SOLTI Breast Cancer Research Group Intervention: Ribociclib (neoadjuvant) Start Date: 2022-05-03 Last Updated: 2023-10-10 Number of Patients: 1100 Recruitment Status: RECRUITING Condition: Breast Cancer Stage II
NCTID: NCT05059262
Title: Study of Vimseltinib for Tenosynovial Giant Cell Tumor Study Summary: This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib. Sponsor: Deciphera Pharmaceuticals LLC Intervention: vimseltinib Start Date: 2021-10-14 Last Updated: 2023-03-16 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Tenosynovial Giant Cell Tumor
NCTID: NCT04531046
Title: Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation Study Summary: This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy. Sponsor: The Lymphoma Academic Research Organisation Intervention: axicabtagene ciloleucel Start Date: 2021-03-10 Last Updated: 2023-09-26 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: B-Cell Lymphoma Refractory
NCTID: NCT04127110
Title: Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients Study Summary: This study includes patients diagnosed with a metastatic non small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) translocation. The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors. During the treatment with an ALK inhibitor, the tumour can start to grow again, because the tumour adapts to the drug and develops escape mechanisms, becoming resistant. At the tumour cells level, the mechanisms underlying resistance can include the development of other alterations, mainly mutations, including in the ALK gene. The alterations that developed depend on the drug the tumour has been exposed to. The alterations can be identified by analysing tumour tissue obtained through a biopsy, however, repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test. Therefore in the last years, new tests have been developed to identify the mutations in the blood. Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors. The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib, based on the alterations found in their genes. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Lorlatinib Start Date: 2020-11-17 Last Updated: 2023-11-03 Number of Patients: 68 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT04567446
Title: Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic Approach Study Summary: Multicentric prospective study with collection of biological samples as part of type II research Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Stool Start Date: 2018-01-22 Last Updated: 2020-09-28 Number of Patients: 1100 Recruitment Status: UNKNOWN Condition: Cancer
NCTID: NCT01256073
Title: A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia Study Summary: The trial is a multi-centre, open-label, safety and tolerability extension trial to the IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML) patients over the age of 60 years, in complete remission, and who are not eligible for allogeneic stem-cell transplantation. The dose given to the individual patient will be the same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for the 12 patients in an additional cohort. Sponsor: Innate Pharma Intervention: IPH2101 Start Date: 2007-02 Last Updated: 2014-02-28 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03547973
Title: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Study Summary: The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2018-08-13 Last Updated: 2023-11-13 Number of Patients: 643 Recruitment Status: RECRUITING Condition: Metastatic Urothelial Cancer
NCTID: NCT02103062
Title: Phase 2 Study With Abraxane (Nab®Paclitaxel) in Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel) in subjects with previously treated metastatic colorectal cancer. Subjects will be placed into two separate cohorts based on their RAS mutation status. Sponsor: Celgene Intervention: ABI-007 Start Date: 2014-05-05 Last Updated: 2020-04-21 Number of Patients: 41 Recruitment Status: COMPLETED Condition: Colorectal Neoplasms
NCTID: NCT02686346
Title: Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE Study Summary: This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma. Sponsor: The Lymphoma Academic Research Organisation Intervention: Brentuximab Vedotin Start Date: 2016-03 Last Updated: 2021-12-07 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Hodgkin Disease
NCTID: NCT03529110
Title: DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Study Summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (T-DXd) Start Date: 2018-08-09 Last Updated: 2023-02-09 Number of Patients: 524 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT02639546
Title: Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors Study Summary: This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose. Sponsor: Hoffmann-La Roche Intervention: Cobimetinib Start Date: 2016-05-20 Last Updated: 2022-09-16 Number of Patients: 56 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT03486873
Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-08-21 Last Updated: 2023-11-27 Number of Patients: 2300 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT01313377
Title: Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient’s condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery. Sponsor: UNICANCER Intervention: gemcitabine hydrochloride Start Date: 2009-07 Last Updated: 2017-01-25 Number of Patients: 190 Recruitment Status: COMPLETED Condition: Extrahepatic Bile Duct Cancer
NCTID: NCT00266877
Title: Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer. Sponsor: Puma Biotechnology, Inc. Intervention: HKI-272 Start Date: 2005-12 Last Updated: 2018-04-13 Number of Patients: 172 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03256994
Title: CIRSE Registry for SIR-Spheres in France (CIRT-FR) Study Summary: Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé <math display="block">HAS</math>). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities. Sponsor: Cardiovascular and Interventional Radiological Society of Europe Intervention: Yttrium-90 loaded SIR-Spheres microspheres Start Date: 2017-08-01 Last Updated: 2022-08-15 Number of Patients: 332 Recruitment Status: COMPLETED Condition: Liver Cancer
NCTID: NCT04927260
Title: French Long Term Registry With Longitudinal Follow up of PDGFRA D842V-GIST Patients Treated With Avapritinib Study Summary: GIST are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT (85%) or the PDGFRα (8%) protein. Treatment of localized forms relies on adequate surgery without tumor spillage and sometimes systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. More than 40% of cases may recur and metastasize. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as imatinib (standard treatment), sunitinib (2nd line) and regorafenib (3rd line). Nevertheless, imatinib has little or no activity in patients harboring the D842V mutation in the exon 18 of PDGFRα (20% of gastric GIST, 6% of all GIST patients). Consequently, other therapeutic alternatives are needed. Results from the phase I single-arm NAVIGATOR study show that avapritinib has significant efficacy in GIST patients with PDGFRα D842V mutation (ORR = 86 %). In France, an authorization for temporary use (ATUc) starting on September 21st, 2020 has been granted by the National Agency for Safety of Medicines and Health Products (ANSM). It allows the early availability of avapritinib in France while waiting for Market Authorization Approval (AMM). This ATUc will be accompanied by a protocol of therapeutic use and collection of information (PUT) that describes the frequency of patient visits. The objective of this real-life registry is to perform a long-term longitudinal follow up of PDGFRA D842V-mutated GIST patients treated with avapritinib and to collect effectiveness and safety data. It will be implemented in parallel to the ATUc until June 2023. Data from the electronic health record (EHR) will be collected. Moreover, as per the ANSM’s requirements, quality of life and cognitive function will be investigated using FACT-G, FACT-Cog and MoCA questionnaires. Undesirable effects will be collected as well. Follow-up is envisioned for a minimum of 2 years. Sponsor: Centre Leon Berard Intervention: Patient treated by Avapritinib in real life Start Date: 2021-03-31 Last Updated: 2021-06-15 Number of Patients: 45 Recruitment Status: RECRUITING Condition: GIST
NCTID: NCT02972060
Title: ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer Study Summary: This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control. The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT. In total, this 1:1 randomized study will therefore require randomization of at least 250 patients, 125 to each arm. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: ODM-201 Start Date: 2017-12-01 Last Updated: 2023-09-07 Number of Patients: 61 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT01397877
Title: GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer Study Summary: This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy. Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2). Disease progression is defined by the RECIST 1.1 criteria Sponsor: ARCAGY/ GINECO GROUP Intervention: BKM120 Start Date: 2011-12 Last Updated: 2023-09-06 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT04043494
Title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma Study Summary: Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02) Sponsor: University Hospital Muenster Intervention: Cyclophosphamide Start Date: 2019-08-23 Last Updated: 2022-12-16 Number of Patients: 683 Recruitment Status: RECRUITING Condition: Lymphoblastic Lymphoma, Childhood
NCTID: NCT03474094
Title: Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy Study Summary: This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients. Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive: * Arm A: Radiotherapy followed by atezolizumab then surgery. * Arm B: Atezolizumab followed by surgery then radiotherapy. * Arm C: Radiotherapy then surgery followed by atezolizumab. The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same: * Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W). * Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy. * Surgery will be performed as per institutional practice. Randomisation will be stratified according to histological subtypes as follows: Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS. Sponsor: Centre Leon Berard Intervention: Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery Start Date: 2018-08-01 Last Updated: 2023-01-27 Number of Patients: 69 Recruitment Status: RECRUITING Condition: Sarcoma,Soft Tissue
NCTID: NCT03362177
Title: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer Study Summary: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer Sponsor: Amgen Intervention: Romiplostim Start Date: 2019-09-30 Last Updated: 2023-11-01 Number of Patients: 162 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chemotherapy-induced Thrombocytopenia
NCTID: NCT00232960
Title: Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC Study Summary: There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Radiotherapy 50 Gy Start Date: 2005-10 Last Updated: 2012-03-28 Number of Patients: 310 Recruitment Status: UNKNOWN Condition: Oral Cancer
NCTID: NCT00545129
Title: A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone Study Summary: The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone. Sponsor: Pfizer Intervention: Tanezumab 10 mg IV Start Date: 2009-04-29 Last Updated: 2021-06-18 Number of Patients: 59 Recruitment Status: COMPLETED Condition: Neoplasm Metastasis
NCTID: NCT03260894
Title: Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC. Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-07 Last Updated: 2023-10-26 Number of Patients: 129 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma (RCC)
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-21 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03437200
Title: Combination of Chemoradiation With Immunotherapy in Inoperable œsophageal Cancer Study Summary: The main objective of the trial is to assess the feasibility and the safety of the addition of immunotherapy with PD-1 antibody nivolumab +/- CTLA-4 antibody ipilimumab to concomitant chemoradiation therapy (CRT) in inoperable patients with early or locally advanced oesophageal cancer and to select the more promising experimental arm among the two possible combinations in terms of activity (based on progression free survival (PFS) at 12 months according to RECIST 1.1) for further evaluation in a phase III trial. The secondary objectives will aim to evaluate progression-free survival, failure-free survival and overall survival and pattern of progression (including incidence of distance metastasis). Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab Start Date: 2019-01-17 Last Updated: 2023-02-21 Number of Patients: 8 Recruitment Status: TERMINATED Condition: Inoperable œsophageal Cancer
NCTID: NCT00014300
Title: Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: glufosfamide Start Date: 2001-01 Last Updated: 2012-09-24 Number of Patients: 32 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT04819100
Title: A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) Study Summary: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: 2021-12-20 Last Updated: 2023-10-19 Number of Patients: 170 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01557114
Title: Study of Radiotherapy Administered in Combination With Ipilimumab in Patients With Unresectable Stage III or Stage IV Advanced Malignant Melanoma Study Summary: RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association with melanoma peptides has been shown as well as synergy between radiation therapy and anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant effects.Radiotherapy increases tumor immunogenicity in several preclinical models by increasing MHC molecules expression and is able to induce significant tumor reduction in around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens (TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the immune antitumor response. In this therapeutical model, the use of the own patient tumor as a source of tumor antigens (in opposition with other vaccination protocols, where TAA are exogenic) is particularly adapted. PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy administered in combination with ipilimumab. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Ipilimumab Start Date: 2011-03 Last Updated: 2016-06-09 Number of Patients: 19 Recruitment Status: TERMINATED Condition: Malignant Melanoma
NCTID: NCT01323400
Title: Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST) Study Summary: The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study. Sponsor: Centre Leon Berard Intervention: Pazopanib Start Date: 2011-03 Last Updated: 2016-02-25 Number of Patients: 81 Recruitment Status: COMPLETED Condition: GIST
NCTID: NCT04158700
Title: A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer Study Summary: The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body. Sponsor: Eli Lilly and Company Intervention: LY3200882 Start Date: 2019-12-05 Last Updated: 2020-02-19 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Advanced Cancer
NCTID: NCT02633800
Title: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) Study Summary: This study will test an investigational study drug called patritumab. It is a ‘randomized study’ which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product. Sponsor: Daiichi Sankyo, Inc. Intervention: Patritumab Start Date: 2015-12-22 Last Updated: 2019-01-07 Number of Patients: 87 Recruitment Status: TERMINATED Condition: Head and Neck Neoplasms
NCTID: NCT02539537
Title: A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma Study Summary: French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma. Sponsor: UNICANCER Intervention: Gemcitabine Start Date: 2015-10-23 Last Updated: 2023-10-16 Number of Patients: 171 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Cancer
NCTID: NCT01884922
Title: Study Of Vinblastine in Combination With Nilotinib in Children, Adolescents and Young Adults Study Summary: Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nilotinib Start Date: 2013-05-29 Last Updated: 2022-05-27 Number of Patients: 35 Recruitment Status: COMPLETED Condition: Refractory Low-grade Gliomas
NCTID: NCT03465722
Title: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST Study Summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs. Sponsor: Blueprint Medicines Corporation Intervention: avapritinib Start Date: 2018-03-26 Last Updated: 2022-10-06 Number of Patients: 476 Recruitment Status: COMPLETED Condition: GIST
NCTID: NCT00790322
Title: Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy Study Summary: The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy. Sponsor: Biotec Pharmacon ASA Intervention: SBG Start Date: 2008-10 Last Updated: 2010-02-19 Number of Patients: 130 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT04168788
Title: Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL Study Summary: Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient’s quality of life, serious long-term sequelae and are potentially fatal in children. The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children. Sponsor: University Hospital, Angers Intervention: Blood test for genetic analysis Start Date: 2020-01-01 Last Updated: 2019-11-19 Number of Patients: 150 Recruitment Status: UNKNOWN Condition: Hepatic Veno-Occlusive Disease
NCTID: NCT00181038
Title: Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery Study Summary: This trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Peri-Neuronal Catheter Start Date: 2004-06 Last Updated: 2007-08-28 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Oropharyngeal Neoplasms
NCTID: NCT04741438
Title: Efficacy of the Combination of Nivolumab and Ipilimumab as a Treatment in Patients With Sarcoma of Rare Subtype Study Summary: This is a randomized open label study, with 2 arms treatments conducted in patients with metastatic or unresectable advanced sarcoma of rare subtype; previously treated by anthracycline-based regimen except for whom standard therapy does not exist or is not considered appropriate by the Investigator. In the experimental arm, patients will receive the combination of Nivolumab + Ipilimumab for a maximum of 24 months, whereas in the control arm, patients will receive Pazopanib alone. The purpose of the study is to know if the combination of nivolumab + ipilimumab can be more efficient than Pazopanib in terms of Progression-Free Survival. Sponsor: Centre Leon Berard Intervention: Nivolumab and IPILIMUMAB Start Date: 2021-03-30 Last Updated: 2023-08-30 Number of Patients: 96 Recruitment Status: RECRUITING Condition: Sarcoma
NCTID: NCT03132038
Title: Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck Study Summary: INDICATION: Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy. Sponsor: UNICANCER Intervention: Nivolumab Start Date: 2017-03-24 Last Updated: 2022-01-11 Number of Patients: 98 Recruitment Status: COMPLETED Condition: Salivary Gland Carcinoma
NCTID: NCT01598038
Title: Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma Study Summary: The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy. Sponsor: Centre Francois Baclesse Intervention: Blood sample Start Date: 2012-04 Last Updated: 2017-07-28 Number of Patients: 41 Recruitment Status: TERMINATED Condition: Renal Cell Carcinoma
NCTID: NCT00104689
Title: Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer. Sponsor: UNICANCER Intervention: capecitabine Start Date: 2003-06-30 Last Updated: 2021-02-21 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03972488
Title: Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET Study Summary: The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression. Sponsor: Advanced Accelerator Applications Intervention: Lutathera Start Date: 2020-01-22 Last Updated: 2023-10-24 Number of Patients: 222 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastro-enteropancreatic Neuroendocrine Tumor
NCTID: NCT01626638
Title: Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL) Study Summary: The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Confocal Micro Endoscopy Start Date: 2013-02-01 Last Updated: 2021-02-18 Number of Patients: 44 Recruitment Status: COMPLETED Condition: Malignant Pharyngo Laryngeal Tumors
NCTID: NCT05118789
Title: A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Study Summary: Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. Sponsor: Nuvalent Inc. Intervention: NVL-520 Start Date: 2022-01-04 Last Updated: 2023-11-07 Number of Patients: 359 Recruitment Status: RECRUITING Condition: Locally Advanced Solid Tumor
NCTID: NCT04621188
Title: Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) Study Summary: ROS1 rearrangements are present in 1-2% of NSCLC cases and define a distinct molecular subgroup. Like ALK (anaplastic lymphoma kinase) rearrangements in NSCLC, ROS1 fusions confer sensitivity to the inhibitor crizotinib. Crizotinib, which is a tyrosine kinase inhibitor (TKI), has been shown to be effective in tumors in several retrospective studies. Recently the FDA approved entrectinib for the treatment of patients with ROS1-positive metastatic NSCLC. This indication is based on the results of pooled data from several trials. Together, these studies demonstrate the efficacy for entrectinib across a variety of solid tumor types including NSCLC with ROS1 fusion. However, despite the efficacy of crizotinib or entrectinib in ROS1-positive NSCLC, patients will develop resistance to these tyrosine kinase inhibitors. Lorlatinib is a new and potent ROS1 / ALK inhibitor optimized to penetrate the blood-brain barrier. A recent study has investigated the activity of lorlatinib against the crizotinib-resistant ROS1G2032R mutation. In this situation, lorlatinib effectively inhibited the catalytic activity of recombinant ROS1G2032R resulting in an antiproliferative response. Because of its potency as an ROS1 inhibitor and its ability to suppress the resistant ROS1 mutations, lorlatinib could be a treatment of choice in ROS1-positive NSCLC. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Lorlatinib Start Date: 2021-03-19 Last Updated: 2023-09-29 Number of Patients: 84 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer Metastatic
NCTID: NCT04595565
Title: Sacituzumab Govitecan in Primary HER2-negative Breast Cancer Study Summary: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting. Sponsor: German Breast Group Intervention: Capecitabine Start Date: 2020-10-28 Last Updated: 2023-03-02 Number of Patients: 1332 Recruitment Status: RECRUITING Condition: HER2-negative Breast Cancer
NCTID: NCT01454089
Title: A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer Study Summary: The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm. Sponsor: Achieve Life Sciences Intervention: OGX-427 600 mg Start Date: 2011-10 Last Updated: 2016-10-07 Number of Patients: 183 Recruitment Status: COMPLETED Condition: Urologic Neoplasms
NCTID: NCT01085838
Title: Erlotinib in Higher Risk Myelodysplastic Syndrome Study Summary: The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Erlotinib Start Date: 2010-07 Last Updated: 2016-11-08 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndrome
NCTID: NCT02416388
Title: Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR Study Summary: This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest. Sponsor: University Hospital, Angers Intervention: Idarubicin Start Date: 2015-01 Last Updated: 2020-10-20 Number of Patients: 3100 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT04029688
Title: A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors Study Summary: This is a Phase I/II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with chemotherapy or venetoclax, in pediatric and young adult participants with acute leukemias or solid tumors. This study is divided into three parts: Part 1 will begin with dose escalation of idasanutlin as a single agent in pediatric participants with relapsed or refractory solid tumors to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and to characterize dose-limiting toxicities (DLTs). Following MTD/MAD identification, three separate safety run-in cohorts in neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) will be conducted to identify the recommended Phase 2 dose (RP2D) of idasanutlin in each combination, with chemotherapy or venetoclax. Part 2 will evaluate the safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult participants in neuroblastoma, AML,and ALL cohorts at idasanutlin RP2D. Part 3 will potentially be conducted as an additional expansion phase of the idasanutlin combination cohorts in neuroblastoma, AML, or ALL for further response and safety assessment. Sponsor: Hoffmann-La Roche Intervention: Idasanutlin Start Date: 2020-01-27 Last Updated: 2023-11-13 Number of Patients: 183 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT03739138
Title: Intratumoral/Intralesional Administration of MK-4621/JetPEI™ With or Without Pembrolizumab in Participants With Advanced/Metastatic or Recurrent Solid Tumors (MK-4621-002) Study Summary: The purpose of this study is to evaluate safety and tolerability, pharmacokinetics (PK), and preliminary antitumor activity of intratumoral (IT) / intralesional injections of MK-4621 delivered via the JetPEI™ in vivo linear polyethylenimine nucleic acid delivery system as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors. Sponsor: Merck Sharp & Dohme LLC Intervention: MK-4621 Start Date: 2018-12-18 Last Updated: 2022-02-28 Number of Patients: 30 Recruitment Status: TERMINATED Condition: Advanced Solid Tumors
NCTID: NCT01876043
Title: Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial Study Summary: Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic. Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by well-differentiated component associated with a contingent sarcomatous differentiation and fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical removal impossible in a high proportion of cases. Operable tumors have also a risk of local recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only very limited effectiveness. Progression-free survival of patients does not exceed 2 months. The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and 6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD. plitidepsin could represent the treatment of choice for patients with advanced LDD. The objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with locally advanced dedifferentiated liposarcomas and / or metastatic. Sponsor: Institut Bergonié Intervention: plitidepsin Start Date: 2012-02 Last Updated: 2021-01-25 Number of Patients: 24 Recruitment Status: TERMINATED Condition: Adult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated Liposarcoma
NCTID: NCT02808247
Title: Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma Study Summary: This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival. The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide. Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics. Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nintedanib Start Date: 2017-07-07 Last Updated: 2021-09-20 Number of Patients: 80 Recruitment Status: TERMINATED Condition: Sarcoma, Soft Tissue
NCTID: NCT02205047
Title: Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma Study Summary: The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Cisplatin Start Date: 2015-07-15 Last Updated: 2023-02-16 Number of Patients: 171 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Malignant Neoplasm of Stomach
NCTID: NCT02913443
Title: A Dose Finding and Expansion Study of RO7051790 Administered Orally in Participants With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC) Study Summary: This is a Phase I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790. Sponsor: Hoffmann-La Roche Intervention: RO7051790 Start Date: 2016-12-20 Last Updated: 2018-10-19 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT03473743
Title: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer Study Summary: The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease. Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2018-04-05 Last Updated: 2023-10-25 Number of Patients: 125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT02105168
Title: Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment Study Summary: Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Blood sample Start Date: 2009-07 Last Updated: 2016-06-10 Number of Patients: 2200 Recruitment Status: UNKNOWN Condition: Melanoma
NCTID: NCT02077868
Title: Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Study Summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer. Sponsor: Mologen AG Intervention: Usual Maintenance Start Date: 2014-09 Last Updated: 2019-09-10 Number of Patients: 540 Recruitment Status: UNKNOWN Condition: Metastatic Colorectal Cancer
NCTID: NCT01035268
Title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella Study Summary: This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse. During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos. Sponsor: Institut Claudius Regaud Intervention: fatty tissue transfer Start Date: 2010-02-08 Last Updated: 2018-08-22 Number of Patients: 196 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT01907100
Title: Nintedanib (BIBF 1120) in Mesothelioma Study Summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma. Sponsor: Boehringer Ingelheim Intervention: Nintedanib Start Date: 2013-09-19 Last Updated: 2019-03-18 Number of Patients: 545 Recruitment Status: TERMINATED Condition: Mesothelioma
NCTID: NCT03967522
Title: Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases Study Summary: This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC). Sponsor: Centre Leon Berard Intervention: Cabozantinib Start Date: 2019-11-29 Last Updated: 2023-08-31 Number of Patients: 77 Recruitment Status: RECRUITING Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT05238922
Title: Study of INCB123667 in Subjects With Advanced Solid Tumors Study Summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. Sponsor: Incyte Corporation Intervention: INCB0123667 Start Date: 2022-07-05 Last Updated: 2023-11-03 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT00227747
Title: Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer. Sponsor: UNICANCER Intervention: capecitabine Start Date: 2005-11-08 Last Updated: 2021-02-17 Number of Patients: 598 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT05208047
Title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors Study Summary: This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Sponsor: Cogent Biosciences, Inc. Intervention: CGT9486 plus sunitinib Start Date: 2022-04-14 Last Updated: 2023-11-28 Number of Patients: 426 Recruitment Status: RECRUITING Condition: Advanced Gastrointestinal Stromal Tumors
NCTID: NCT02040064
Title: Tolerability and Efficacy of Tremelimumab in Combination With Gefitinib in NSCLC Patients Study Summary: This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety and tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and to establish a recommended phase 2 dose. Secondary objectives include evaluation of, pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab combination. The exploratory objectives are to evaluate biomarkers that may correlate with activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib. The biological rationale for such a study is that even though the disease is progressing it is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover, patients may have received chemotherapy and the likelihood of chemosensitivity is very low. So, the association of Gefitinib with immune checkpoint blockade is very attractive and may result in clinical benefit in NSCLC with EGFRmut. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Gefitinib Start Date: 2014-01 Last Updated: 2016-06-09 Number of Patients: 27 Recruitment Status: COMPLETED Condition: Non Small Cell Lung Cancer
NCTID: NCT04270864
Title: Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers Study Summary: Open label, phase Ib study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab. The trial will be divided into two parts: PART A: the first part will assess the safety of two regimen and will recruit patients with all types of injectable solid malignancies PART B: the second part will include 3 expansion cohorts of 15 patients: * B1: anti-PD-1 refractory advanced NSCLC cohort * B2: anti-PD-1 refractory advanced melanoma cohort * B3: immunotherapy naïve microsatellite stable colorectal cancer (MSS CRC) cohort Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Ipilimumab Start Date: 2020-04-10 Last Updated: 2023-02-14 Number of Patients: 72 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Cancer
NCTID: NCT01189253
Title: Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: doxorubicin hydrochloride Start Date: 2011-05 Last Updated: 2014-08-08 Number of Patients: 133 Recruitment Status: TERMINATED Condition: Sarcoma
NCTID: NCT01808573
Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting Study Summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2013-03-29 Last Updated: 2021-06-11 Number of Patients: 621 Recruitment Status: COMPLETED Condition: HER2+ Metastatic Breast Cancer (MBC)
NCTID: NCT02494973
Title: Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases Study Summary: Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR, after resection of CRLM have been reported. The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and were clinically tolerable. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Oxaliplatin HAI Start Date: 2015-05-26 Last Updated: 2023-08-22 Number of Patients: 104 Recruitment Status: SUSPENDED Condition: Colorectal Cancer
NCTID: NCT04267146
Title: Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma Study Summary: Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, safety run study in nine patients. In case of safety issue a -1 dose level will be tested. Phase II : Open label, non randomized, efficacy study of nivolumab in addition to radiotherapy and temozolomide. This phase will start when the RP2D has been defined after the last patients evaluable for DLT achieved the first 6 weeks of treatment (the radio-chemotherapy period) with a DLT rate below 30% during the the phase I study. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Nivolumab Start Date: 2019-07-15 Last Updated: 2020-02-12 Number of Patients: 40 Recruitment Status: RECRUITING Condition: High Grade Glioma
NCTID: NCT03412773
Title: Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC Study Summary: This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2017-12-28 Last Updated: 2023-07-05 Number of Patients: 674 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hepatocellular Carcinoma (HCC)
NCTID: NCT05182164
Title: Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas Study Summary: Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas. Sponsor: Institut Bergonié Intervention: Association of pembrolizumab + cabozantinib Start Date: 2022-04-25 Last Updated: 2023-09-28 Number of Patients: 119 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma Adult
NCTID: NCT01429064
Title: Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001 Study Summary: The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer. Sponsor: Orion Corporation, Orion Pharma Intervention: ODM-201 Start Date: 2011-06 Last Updated: 2017-02-20 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04216953
Title: MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma Study Summary: The proposed study conducted in adult and pediatric patients aims to evaluate the safety and clinical activity of atezolizumab + cobimetinib in advanced/metastatic soft tissue sarcomas (up to 80 patients). Sponsor: Centre Leon Berard Intervention: Cobimetinib Start Date: 2020-02-12 Last Updated: 2023-07-25 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Sarcoma,Soft Tissue
NCTID: NCT03930953
Title: A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) Study Summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin’s lymphomas. Sponsor: Celgene Intervention: CC-99282 Start Date: 2019-05-20 Last Updated: 2023-11-01 Number of Patients: 348 Recruitment Status: RECRUITING Condition: Lymphoma, Non-Hodgkin
NCTID: NCT00367861
Title: Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance Study Summary: Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients. Sponsor: Centre Leon Berard Intervention: interruption of Glivec® Start Date: 2002-05 Last Updated: 2014-02-24 Number of Patients: 564 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT00039364
Title: Imatinib Mesylate in Treating Patients With Gliomas Study Summary: RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: imatinib mesylate Start Date: 2002-03 Last Updated: 2012-07-24 Number of Patients: 112 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT02992964
Title: Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers Study Summary: This is an open-label, single arm, multi-center, pilot study of Nivolumab in pediatric patients with recurrent or refractory hypermutant malignancies aged 12 months to 18 years of age. This study is to assess clinical and radiological benefits of treatment with Nivolumab in children with hypermutated cancers, including those with bMMRD syndrome. It is our expectation that patients with bMMRD syndrome will account for the majority of patients enrolled on this study. Sponsor: The Hospital for Sick Children Intervention: Nivolumab Start Date: 2017-05-15 Last Updated: 2023-11-22 Number of Patients: 11 Recruitment Status: TERMINATED Condition: Refractory or Recurrent Hypermutated Malignancies
NCTID: NCT04790253
Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) Study Summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Prophylactic cranial irradiation Start Date: 2022-10-27 Last Updated: 2023-11-03 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT03117361
Title: Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide Study Summary: This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide. Sponsor: PharmaMar Intervention: plitidepsin Start Date: 2017-05-08 Last Updated: 2020-12-02 Number of Patients: 10 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT03010553
Title: Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot Study Summary: Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a 99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along with the other lymph nodes of the selective group II and III recess. Sentinel lymph node staging alone and complete dissection with routine anatomical pathology will be compared If this technique is reliable it will make a therapeutic de-escalation in the treatment of small tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node is free from metastasis and also to better choose the treatment in case of lymph node involvement Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Detection and resection of sentinel lymph node Start Date: 2008-02 Last Updated: 2017-01-05 Number of Patients: 100 Recruitment Status: UNKNOWN Condition: Head and Neck Cancer
NCTID: NCT03793361
Title: Phase II Study of Regorafenib as Maintenance Therapy Study Summary: Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy. Sponsor: Centre Oscar Lambret Intervention: Regorafenib Start Date: 2019-05-15 Last Updated: 2023-06-23 Number of Patients: 126 Recruitment Status: SUSPENDED Condition: Metastatic Soft Tissue Sarcoma
NCTID: NCT02322853
Title: A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors Study Summary: Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor. Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway. LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2). Sponsor: Centre Francois Baclesse Intervention: Tamoxifen Start Date: 2015-01 Last Updated: 2017-05-24 Number of Patients: 8 Recruitment Status: TERMINATED Condition: Postmenopausal
NCTID: NCT01485861
Title: Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy Study Summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone. Sponsor: Genentech, Inc. Intervention: Abiraterone Start Date: 2012-01-11 Last Updated: 2023-09-14 Number of Patients: 298 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT02598960
Title: An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread. Study Summary: The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread. Sponsor: Bristol-Myers Squibb Intervention: BMS-986156 Start Date: 2015-10-14 Last Updated: 2023-03-06 Number of Patients: 295 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT01548677
Title: Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer Study Summary: This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood. Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: trastuzumab Start Date: 2013-04 Last Updated: 2019-03-13 Number of Patients: 1317 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04031677
Title: Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma Study Summary: This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Surgery Start Date: 2021-01-20 Last Updated: 2023-10-27 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Retroperitoneal Sarcoma
NCTID: NCT02288377
Title: A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET) Study Summary: This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: lanreotide Start Date: 2015-01 Last Updated: 2023-01-18 Number of Patients: 53 Recruitment Status: TERMINATED Condition: Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
NCTID: NCT05512377
Title: Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder Study Summary: This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. Sponsor: Boehringer Ingelheim Intervention: brigimadlin Start Date: 2022-11-25 Last Updated: 2023-11-28 Number of Patients: 155 Recruitment Status: RECRUITING Condition: Pancreatic Neoplasms
NCTID: NCT02515877
Title: Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers Study Summary: The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages <math display="block">1, 2</math> locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: External radiotherapy + curietherapy Start Date: 2008-01 Last Updated: 2016-06-09 Number of Patients: 15 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT03833661
Title: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) Study Summary: The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: M7824 Start Date: 2019-03-26 Last Updated: 2023-10-25 Number of Patients: 159 Recruitment Status: COMPLETED Condition: Biliary Tract Cancer
NCTID: NCT01874353
Title: Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy Study Summary: A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy. Sponsor: AstraZeneca Intervention: Olaparib 300mg tablets Start Date: 2013-09-03 Last Updated: 2023-10-23 Number of Patients: 327 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Platinum Sensitive
NCTID: NCT01481129
Title: Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Study Summary: This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sponsor: National Cancer Institute (NCI) Intervention: Akt Inhibitor MK2206 Start Date: 2011-12 Last Updated: 2017-09-28 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT02818829
Title: Biological and Clinical Database for Pancreatic Adenocarcinoma Study Summary: BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA and RNA from tumors cells. The mission of this prospective project is to make available to the scientific community a clinical biological base from patients with pancreatic adenocarcinoma Sponsor: University Hospital, Toulouse Intervention: Collection of biological samples Start Date: 2014-03 Last Updated: 2020-07-30 Number of Patients: 1500 Recruitment Status: UNKNOWN Condition: Pancreatic Adenocarcinoma
NCTID: NCT00003860
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer. Sponsor: UNICANCER Intervention: filgrastim Start Date: 1998-09 Last Updated: 2021-02-21 Number of Patients: 36 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT03734029
Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Study Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants’ cancer: * Cannot be removed by an operation * Has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (DS-8201a) Start Date: 2018-12-27 Last Updated: 2023-06-15 Number of Patients: 557 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00017277
Title: Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: epoetin alfa Start Date: 2001-03 Last Updated: 2012-09-24 Number of Patients: 47 Recruitment Status: TERMINATED Condition: Head and Neck Cancer
NCTID: NCT04746729
Title: Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy Study Summary: The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of modern external beam radiotherapy techniques in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank. Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Intervention: No intervention Start Date: 2022-03-01 Last Updated: 2021-03-16 Number of Patients: 2670 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT01739764
Title: An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol Study Summary: This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol’s criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2013-02-19 Last Updated: 2021-01-07 Number of Patients: 215 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04965753
Title: FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors Study Summary: This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors. Sponsor: Foghorn Therapeutics Inc. Intervention: FHD-609 Start Date: 2021-08-17 Last Updated: 2023-04-27 Number of Patients: 104 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Synovial Sarcoma
NCTID: NCT00003061
Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cytarabine Start Date: 1997-07 Last Updated: 2012-07-02 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01909453
Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) Sponsor: Pfizer Intervention: LGX818 Start Date: 2013-12-13 Last Updated: 2023-09-07 Number of Patients: 921 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05255653
Title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features Study Summary: The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer: * p53 abnormal endometrial cancer patients to the p53abn-RED trial * mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial * no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial * POLE mutant endometrial cancer patients to the POLEmut-BLUE trial Sponsor: Leiden University Medical Center Intervention: Olaparib Start Date: 2021-11-11 Last Updated: 2023-07-13 Number of Patients: 1615 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT04472429
Title: Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). Study Summary: This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy. Sponsor: Incyte Corporation Intervention: carboplatin Start Date: 2021-01-12 Last Updated: 2023-07-12 Number of Patients: 308 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Anal Canal
NCTID: NCT02988960
Title: A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors Study Summary: This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors. Sponsor: AbbVie Intervention: ABBV-927 Start Date: 2017-02-22 Last Updated: 2023-02-14 Number of Patients: 163 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors Cancer
NCTID: NCT01248429
Title: Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases Study Summary: This study describes the elevation of CPK in patient treated for solid tumors by TKI Sponsor: Centre Oscar Lambret Intervention: CPK dosage Start Date: 2010-11 Last Updated: 2012-06-07 Number of Patients: 154 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT03665129
Title: IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors Study Summary: This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors. Sponsor: Innate Pharma Intervention: IPH5401 and Durvalumab Start Date: 2018-09-07 Last Updated: 2022-01-27 Number of Patients: 73 Recruitment Status: TERMINATED Condition: Advanced Solid Tumors
NCTID: NCT04260529
Title: CyPep-1 Injections in Cancer Inducing Lymphocyte Infiltrate Accumulations Study Summary: This Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CyPep-1 when administered directly into malignant tumors in monotherapy and in combination with anti-PD-1 antibody pembrolizumab. Additionally, the trial will monitor anti-tumor effects on both injected lesions and distant non-injected deposits. Sponsor: Cytovation AS Intervention: CyPep-1 Start Date: 2020-04-30 Last Updated: 2023-09-21 Number of Patients: 75 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumor Malignancy
NCTID: NCT01261429
Title: Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT) Study Summary: The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS/TGCT) who cannot be treated by surgery. The primary objective of the study will be to determine the efficacy of 12 weeks (3 months) of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + Stable disease according to Response Evaluation Criteria In Solid Tumours - RECIST version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by surgery. this study is an international, multicentre, non-randomized, open-label phase II clinical trial with a Bayesian design. A maximum sample size of 50 patients will be included in the study Sponsor: Centre Leon Berard Intervention: Tasigna Start Date: 2010-12 Last Updated: 2013-04-16 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Pigmented Villonodular Synovitis
NCTID: NCT04634877
Title: Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) Study Summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-01-10 Last Updated: 2023-11-21 Number of Patients: 990 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT01191060
Title: Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years Study Summary: Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months). Sponsor: University Hospital, Toulouse Intervention: Lenalidomide, Bortezomib Start Date: 2010-10 Last Updated: 2019-04-18 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Myeloma
NCTID: NCT00518895
Title: Trial of Dacarbazine With or Without Genasense in Advanced Melanoma Study Summary: This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense. Sponsor: Genta Incorporated Intervention: dacarbazine plus Genasense Start Date: 2007-07 Last Updated: 2011-11-06 Number of Patients: 300 Recruitment Status: COMPLETED Condition: Melanoma
NCTID: NCT04317599
Title: A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC) Study Summary: The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications. Sponsor: Pierre Fabre Medicament Intervention: Non Interventional study Start Date: 2020-04-12 Last Updated: 2023-01-25 Number of Patients: 274 Recruitment Status: COMPLETED Condition: BRAF V600E Mutation Positive
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT04221035
Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vincristine Start Date: 2019-11-05 Last Updated: 2023-02-13 Number of Patients: 800 Recruitment Status: RECRUITING Condition: High-Risk Neuroblastoma
NCTID: NCT01856296
Title: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies Study Summary: An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Biopsy Start Date: 2013-04-23 Last Updated: 2019-06-18 Number of Patients: 303 Recruitment Status: COMPLETED Condition: Metastatic Cancer
NCTID: NCT00126269
Title: Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary Study Summary: This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis. The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: cisplatin Start Date: 2003-05 Last Updated: 2006-09-08 Number of Patients: 192 Recruitment Status: UNKNOWN Condition: Carcinoma
NCTID: NCT05076396
Title: PM14 Administered Intravenously to Patients With Advanced Solid Tumors Study Summary: Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors. Sponsor: PharmaMar Intervention: PM14 Start Date: 2017-09-06 Last Updated: 2022-05-24 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT01502696
Title: Adjuvant PEG Intron in Ulcerated Melanoma Study Summary: Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: PEG IFN alfa-2b Start Date: 2012-10 Last Updated: 2019-03-04 Number of Patients: 1200 Recruitment Status: UNKNOWN Condition: Ulcerated Melanomas
NCTID: NCT02781935
Title: Diffusion-Weighted MRI for Liver Metastasis Study Summary: The DREAM study will assess the diagnostic accuracy of diffusion-weighted MRI in combination with other imaging modalities (multiparametric MRI and CT Scan) in determining the true status of disappearing liver metastasis (DLM) detected after conversion systemic therapy for unresectable or borderline resectable colorectal liver metastasis (CRLM). Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: DW-MRI Start Date: 2016-11 Last Updated: 2023-09-07 Number of Patients: 233 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer
NCTID: NCT03351296
Title: Two Chemotherapy Regimens Plus or Minus Bevacizumab Study Summary: Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in combination with bevacizumab (beva) on progression-free survival (PFS) and compare the chemotherapy regimens alone or with beva (two by two design) on the same criteria. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: LV5FU2 Start Date: 2018-06-26 Last Updated: 2023-05-18 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Pancreatic Cancer
NCTID: NCT01305135
Title: Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes Study Summary: Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing. For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS. For the phase II study: Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS Sponsor: Groupe Francophone des Myelodysplasies Intervention: azacitidine and idarubicin Start Date: 2010-12-30 Last Updated: 2017-06-07 Number of Patients: 41 Recruitment Status: COMPLETED Condition: High Grade Myelodysplastic Syndrome Lesions
NCTID: NCT03296696
Title: Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma Study Summary: This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2). Sponsor: Amgen Intervention: AMG 596 Start Date: 2018-04-18 Last Updated: 2021-12-23 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Glioblastoma or Malignant Glioma
NCTID: NCT03364530
Title: Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma Study Summary: We hypothesized that intra-arterial gemcitabine/oxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma. Sponsor: University Hospital, Montpellier Intervention: Gemcitabine-Oxaliplatin Regimen Start Date: 2018-06-11 Last Updated: 2023-05-03 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Cholangiocarcinoma Non-resectable
NCTID: NCT00180921
Title: Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck Study Summary: This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Imatinib Start Date: 2004-07 Last Updated: 2007-09-26 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Cancer of the Head and Neck
NCTID: NCT01896531
Title: A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Study Summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 <math display="block">mFOLFOX6</math>) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle. Sponsor: Genentech, Inc. Intervention: 5-Fluorouracil Start Date: 2013-08-14 Last Updated: 2022-03-02 Number of Patients: 153 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT01786031
Title: Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program Study Summary: Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: metastasis biopsy Start Date: 2012-12 Last Updated: 2016-02-08 Number of Patients: 55 Recruitment Status: COMPLETED Condition: Metastatic Castration Resistant Prostate Cancer Patients
NCTID: NCT05888831
Title: A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors. Sponsor: Bristol-Myers Squibb Intervention: BMS-986449 Start Date: 2023-06-06 Last Updated: 2023-11-07 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT01167530
Title: Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer Study Summary: The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung cancer. First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Everolimus Start Date: 2008-03 Last Updated: 2012-04-04 Number of Patients: 36 Recruitment Status: UNKNOWN Condition: Non-small Cell Lung Cancer
NCTID: NCT05581121
Title: PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer Study Summary: This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France. In this trial, patients will be assigned in one of the two following treatments arms: Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations. Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Each patient will be followed up for 5 years. Sponsor: Institut Claudius Regaud Intervention: Standard treatment: Control arm Start Date: 2023-12 Last Updated: 2023-10-30 Number of Patients: 510 Recruitment Status: NOT_YET_RECRUITING Condition: Cervical Carcinoma
NCTID: NCT04233021
Title: Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation Study Summary: Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment. In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication. Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood. Sponsor: Intergroupe Francophone de Cancerologie Thoracique Intervention: Osimertinib Start Date: 2020-07-16 Last Updated: 2023-07-27 Number of Patients: 57 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non Small Cell Lung Cancer Metastatic
NCTID: NCT05350631
Title: Efficacy Study on Quality of Life Criteria of a Digital Application on Any Cellphone (OnKO-Tips&Tricks) for Adolescents and Young Adults Diagnosed With Cancer Study Summary: Approximately 2,200 cancers per year in France are diagnosed within the adolescents and young adults population (15-25 years old, AYA). The cancer plans and the INCA recommend support during and after cancer treatment, taking into account both medical and psycho-social specificities related to age (support care, school learning/training and professional integration, fertility preservation, therapeutic education, addictology, sexology…). In this context, AJA teams have been developed in which the Nurse Coordinators (IDEC) play a fundamental role. These Nurse Coordinators are available to young patients, their families and the professionals who accompany follow them in their therapeutic journey. Their main missions are to assess the specific needs of these young people and their loved ones, to inform, orient and participate in the coordination of their care by providing psychosocial and paramedical solutions to these young patients. The circular of 30/05/2016 on the coordinated regional organization of care for AJAs supports the development of connected health tools for AJAs. This population is adept to new technologies, social networks allowing them to continue to be informed and remain integrated to the outside world while helping them prepare for life after cancer. In this context, our team initiated the development of a digital application compatible for any cellphone OnKO-Tips&Tricks meeting these criteria of necessity with the company CAPCOD. We would want to move on to a validation stage by carrying out a national multicenter efficacy study in AJA mobile units by comparing two groups of patients: users
on-users of this digital tool on a main criterion of quality of life after using it for 6 months. As it should promote autonomy and integration into the care pathway as well as active participation in therapeutic education programs (TPE), these different items will be evaluated as secondary endpoints of our study
Sponsor: University Hospital, Strasbourg, France Intervention: OnKO-Tips&Tricks digital phone application Start Date: 2023-04-04 Last Updated: 2023-10-24 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT02428842
Title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4) Study Summary: Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points. Sponsor: Institut Curie Intervention: Tumor biopsies Start Date: 2013-10-24 Last Updated: 2023-01-20 Number of Patients: 419 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT04521621
Title: A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013) Study Summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013. Sponsor: Merck Sharp & Dohme LLC Intervention: Gebasaxturev Start Date: 2020-10-28 Last Updated: 2023-08-14 Number of Patients: 75 Recruitment Status: COMPLETED Condition: Neoplasm Metastasis
NCTID: NCT00055731
Title: Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse Study Summary: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse. Sponsor: UNICANCER Intervention: bicalutamide Start Date: 2002-11-14 Last Updated: 2023-01-18 Number of Patients: 413 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT00162721
Title: The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas Study Summary: This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: doxorubicin, ifosfamide, cisplatin Start Date: 2001-09 Last Updated: 2007-08-10 Number of Patients: 270 Recruitment Status: UNKNOWN Condition: Uterine Sarcoma
NCTID: NCT00003731
Title: Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 1998-12 Last Updated: 2012-09-24 Number of Patients: 39 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT05117242
Title: Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer Study Summary: The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care Sponsor: Genmab Intervention: Acasunlimab Start Date: 2021-10-27 Last Updated: 2023-11-18 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer Metastatic
NCTID: NCT01865110
Title: R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL Study Summary: This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab). Sponsor: The Lymphoma Academic Research Organisation Intervention: R-CHOP Start Date: 2013-11 Last Updated: 2023-09-26 Number of Patients: 623 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT04770246
Title: TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations Study Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations. Sponsor: Taiho Oncology, Inc. Intervention: TAS-117 Start Date: 2021-03-31 Last Updated: 2023-10-06 Number of Patients: 17 Recruitment Status: TERMINATED Condition: Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations
NCTID: NCT01991210
Title: A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC) Study Summary: This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks. Sponsor: Genentech, Inc. Intervention: DNIB0600A Start Date: 2014-02-06 Last Updated: 2017-08-21 Number of Patients: 95 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT01442662
Title: Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine Study Summary: The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine. Sponsor: UNICANCER Intervention: pazopanib + gemcitabine Start Date: 2011-09 Last Updated: 2020-01-31 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Leiomyosarcoma
NCTID: NCT00887146
Title: Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma Study Summary: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma. Sponsor: Alliance for Clinical Trials in Oncology Intervention: concomitant temozolomide (TMZ) Start Date: 2009-09 Last Updated: 2023-11-01 Number of Patients: 360 Recruitment Status: RECRUITING Condition: Brain and Central Nervous System Tumors
NCTID: NCT03374488
Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease. Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-22 Last Updated: 2021-11-30 Number of Patients: 84 Recruitment Status: COMPLETED Condition: UC (Urothelial Cancer)
NCTID: NCT04857138
Title: A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors Study Summary: A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: <math display="block">Part 1</math> Dose-Escalation of RO7300490 as a single agent; <math display="block">Part 2</math> Dose-Escalation of RO7300490 in combination with atezolizumab and <math display="block">Part 3</math> Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types. Sponsor: Hoffmann-La Roche Intervention: RO7300490 Start Date: 2021-05-18 Last Updated: 2023-11-13 Number of Patients: 280 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT00924989
Title: A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma Study Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens Sponsor: Astellas Pharma Inc Intervention: OSI-906 Start Date: 2009-12-01 Last Updated: 2018-09-05 Number of Patients: 139 Recruitment Status: COMPLETED Condition: Adrenocortical Carcinoma
NCTID: NCT02291289
Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. Sponsor: Hoffmann-La Roche Intervention: Cetuximab Start Date: 2015-04-17 Last Updated: 2021-05-26 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT04099888
Title: PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer Study Summary: This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable. Sponsor: PCI Biotech AS Intervention: Fimaporfin and Gemcitabine Start Date: 2019-05-23 Last Updated: 2023-09-11 Number of Patients: 41 Recruitment Status: TERMINATED Condition: Cholangiocarcinoma
NCTID: NCT01098188
Title: LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia Study Summary: This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen. Sponsor: Laboratoire français de Fractionnement et de Biotechnologies Intervention: LFB-R603 Start Date: 2008-11 Last Updated: 2012-04-30 Number of Patients: 33 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00010088
Title: Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct. Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: fluorouracil Start Date: 1999-01 Last Updated: 2009-02-09 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Extrahepatic Bile Duct Cancer
NCTID: NCT03072238
Title: Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer Study Summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC). Sponsor: Hoffmann-La Roche Intervention: Ipatasertib Start Date: 2017-06-30 Last Updated: 2023-09-14 Number of Patients: 1101 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Prostate Cancer
NCTID: NCT04725188
Title: Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002) Study Summary: The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab coformuation Start Date: 2021-04-20 Last Updated: 2023-07-06 Number of Patients: 255 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT03740165
Title: Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score <math display="block">CPS</math>≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-12-18 Last Updated: 2023-09-08 Number of Patients: 1367 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT00077389
Title: Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma. Sponsor: University of Leicester Intervention: carboplatin Start Date: 2004-01 Last Updated: 2014-06-24 Number of Patients: 57 Recruitment Status: UNKNOWN Condition: Liver Cancer
NCTID: NCT03830788
Title: Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy Study Summary: The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to “standard” Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment. Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers. In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities. Sponsor: Center Eugene Marquis Intervention: Radiation by brachytherapy Start Date: 2019-10-04 Last Updated: 2023-03-29 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT04892173
Title: NBTXR3 With or Without Cetuximab in LA-HNSCC Study Summary: This is a global, open-label, randomized, 2-arm, Investigator’s choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC. Sponsor: Nanobiotix Intervention: NBTXR3 Start Date: 2022-01-05 Last Updated: 2023-01-03 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Locally Advanced Head and Neck Squamous Cell Carcinoma
NCTID: NCT00180973
Title: PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE. Study Summary: MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT). Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Hydroxyurea Start Date: 1995-02 Last Updated: 2005-09-16 Number of Patients: 520 Recruitment Status: UNKNOWN Condition: LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT
NCTID: NCT02471846
Title: A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors Study Summary: This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage. Sponsor: Genentech, Inc. Intervention: Atezolizumab Start Date: 2015-07-28 Last Updated: 2019-10-22 Number of Patients: 158 Recruitment Status: COMPLETED Condition: Solid Tumor
NCTID: NCT03511664
Title: Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer Study Summary: The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone. Sponsor: Endocyte Intervention: 177Lu-PSMA-617 Start Date: 2018-05-29 Last Updated: 2023-10-12 Number of Patients: 831 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT01678664
Title: Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors Study Summary: Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases. * H0 a 24 months progression free survival rate less than 35% is unacceptable * H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50% Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Everolimus Start Date: 2012-10 Last Updated: 2020-03-30 Number of Patients: 74 Recruitment Status: COMPLETED Condition: Neuroendocrine Tumors
NCTID: NCT03945773
Title: Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors Study Summary: The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Sponsor: Ipsen Intervention: Cabozantinib Start Date: 2020-01-08 Last Updated: 2023-10-26 Number of Patients: 127 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Renal Cell Carcinoma
NCTID: NCT04561362
Title: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies Study Summary: This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Part B) and Safety and tolerability (Part C). Sponsor: BicycleTx Limited Intervention: BT8009 Start Date: 2020-07-17 Last Updated: 2023-11-14 Number of Patients: 329 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT04731610
Title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma Study Summary: The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause. Sponsor: Institut Curie Intervention: Radiotherapy Start Date: 2021-12-28 Last Updated: 2023-11-15 Number of Patients: 314 Recruitment Status: RECRUITING Condition: Thymoma Malignant Recurrent
NCTID: NCT01864772
Title: Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC Study Summary: The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment). Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Carbo, 5FU, Cetuximab Start Date: 2013-09 Last Updated: 2022-08-19 Number of Patients: 85 Recruitment Status: COMPLETED Condition: Metastatic or Recurrent Head and Neck Squamous Cell Cancer
NCTID: NCT00072462
Title: Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ. Sponsor: Queen Mary University of London Intervention: tamoxifen citrate Start Date: 2003-09 Last Updated: 2021-10-06 Number of Patients: 2980 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02908672
Title: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma Study Summary: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-13 Last Updated: 2023-10-06 Number of Patients: 514 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05152472
Title: A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments Study Summary: This trial is a prospective, randomized (1:1 ratio), multicenter, comparative and phase II study, conducted in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of imatinib (disease progression),sunitinib and regorafenib (either disease progression or intolerance) In the first arm, patients will be treated with imatinib + atezolizumab (experimental arm), whereas in the second arm, patients will be treated with imatinib alone (control arm). The comparison between this two arms will allow to compare whether or not atezolizumab and imatinib is efficient for disease control, in terms of Progression-Free Survival improvement. Sponsor: Centre Leon Berard Intervention: Atezolizumab 1200 mg Start Date: 2022-01-14 Last Updated: 2023-08-01 Number of Patients: 110 Recruitment Status: RECRUITING Condition: Unresectable Gastrointestinal Stromal Tumor (GIST)
NCTID: NCT03006172
Title: To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer Study Summary: This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)). Sponsor: Genentech, Inc. Intervention: Inavolisib Start Date: 2016-12-13 Last Updated: 2023-11-13 Number of Patients: 256 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT02454972
Title: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors Study Summary: Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors Sponsor: PharmaMar Intervention: lurbinectedin (PM01183) Start Date: 2015-08-25 Last Updated: 2023-03-02 Number of Patients: 345 Recruitment Status: COMPLETED Condition: Advanced Solid Tumors
NCTID: NCT03466788
Title: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer Study Summary: Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care Sponsor: Centre Francois Baclesse Intervention: Self questionnaires of quality of life and living conditions Start Date: 2018-03-29 Last Updated: 2020-02-07 Number of Patients: 51 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT00047138
Title: Chemotherapy Before and After Surgery in Treating Children With Wilm’s Tumor Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed during surgery. Giving more chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which chemotherapy regimen after surgery is most effective in treating Wilm’s tumor. PURPOSE: Phase III trial to study the effectiveness of chemotherapy before and after surgery in treating children who have Wilm’s tumor. Sponsor: University of Leicester Intervention: dactinomycin Start Date: 2001-01 Last Updated: 2014-06-24 Number of Patients: 350 Recruitment Status: UNKNOWN Condition: Kidney Cancer
NCTID: NCT02937272
Title: A Study of LY3200882 in Participants With Solid Tumors Study Summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors. Sponsor: Eli Lilly and Company Intervention: LY3200882 Start Date: 2016-11-21 Last Updated: 2023-10-23 Number of Patients: 223 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumor
NCTID: NCT02917772
Title: Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma Study Summary: TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab “boost” cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC. Sponsor: AIO-Studien-gGmbH Intervention: Nivolumab/Ipilimumab Start Date: 2016-10 Last Updated: 2022-10-06 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Carcinoma, Renal Cell
NCTID: NCT01817738
Title: Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer Study Summary: The purpose of this study is to determine whether the new RNActive®-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant. Sponsor: CureVac Intervention: CV9104 Start Date: 2012-08 Last Updated: 2017-02-17 Number of Patients: 197 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT02458638
Title: A Study of Atezolizumab in Advanced Solid Tumors Study Summary: The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody Start Date: 2015-07-16 Last Updated: 2021-06-04 Number of Patients: 474 Recruitment Status: COMPLETED Condition: Tumors
NCTID: NCT04700072
Title: Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02) Study Summary: Substudy 02D is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-05-03 Last Updated: 2023-10-12 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT04570631
Title: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma Study Summary: Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM. Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world. Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects. Sponsor: AbbVie Intervention: Eftozanermin alfa Start Date: 2020-11-05 Last Updated: 2023-07-13 Number of Patients: 40 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT03878342
Title: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast Study Summary: Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences. Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p <0.001). Sixty percent of the patients received tamoxifen in both groups. Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk. Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management. Sponsor: UNICANCER Intervention: Radiotherapy Start Date: 2019-05-10 Last Updated: 2022-08-02 Number of Patients: 300 Recruitment Status: RECRUITING Condition: DCIS
NCTID: NCT04268121
Title: Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas Study Summary: NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery. The objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy. In parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide). Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group Intervention: Neoadjuvant treatment Start Date: 2021-01-05 Last Updated: 2023-06-29 Number of Patients: 78 Recruitment Status: RECRUITING Condition: Neuroendocrine Carcinoma
NCTID: NCT04230642
Title: Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement Study Summary: This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients. Sponsor: Quantum Surgical Intervention: The Quantum Surgical device Start Date: 2020-05-25 Last Updated: 2021-02-04 Number of Patients: 22 Recruitment Status: COMPLETED Condition: Hepatic Tumor
NCTID: NCT03249142
Title: Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer Study Summary: This is a randomized, open, comparative, multi-centre study which will recruit up to 66 patients. The objective is mainly to explore the safety and feasibility in neo-adjuvant first-line ovarian cancer (including patients with primary peritoneal or fallopian tube adenocarcinoma) of various combinations of durvalumab with chemotherapy with or without tremelimumab. Sponsor: ARCAGY/ GINECO GROUP Intervention: ARM A Durvalumab/chemotherapy association Start Date: 2017-10-18 Last Updated: 2023-09-06 Number of Patients: 69 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT01164189
Title: Bevacizumab in Recurrent Grade II and III Glioma Study Summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide is more effective when given with or without bevacizumab in treating patients with recurrent glioma. PURPOSE: This randomized clinical trial is studying how well temozolomide works with or without bevacizumab in treating patients with recurrent glioma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Bevacizumab Start Date: 2011-02 Last Updated: 2019-02-28 Number of Patients: 155 Recruitment Status: COMPLETED Condition: Central Nervous System Tumors
NCTID: NCT02264665
Title: OPALINE : A Study Of Morbidity And Mortality At 2 Years Study Summary: A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression. Sponsor: Pfizer Intervention: sunitinib Start Date: 2015-05-12 Last Updated: 2023-11-13 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
NCTID: NCT00002989
Title: Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of idarubicin plus peripheral stem cell transplantation using the patient’s own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: busulfan Start Date: 1997-03 Last Updated: 2009-02-09 Number of Patients: 207 Recruitment Status: UNKNOWN Condition: Leukemia
NCTID: NCT04417465
Title: First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors Study Summary: The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI. ABBV-CLS-579 is an investigational drug being developed for the treatment of tumors. The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-579 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation, and Part 3 Combination Dose Expansion. Part 1, ABBV-CLS-579 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-579 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-579 will be administered at the determined recommended dose in combination with a PD-1 target agent or with a VEGFR TKI in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists or has failed will be enrolled. Participants will receive study treatment until disease progresses or discontinued. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. Sponsor: Calico Life Sciences LLC Intervention: ABBV-CLS-579 Start Date: 2020-06-03 Last Updated: 2023-07-21 Number of Patients: 263 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors Cancer
NCTID: NCT03604588
Title: Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers Study Summary: To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: HPV OncoTect™ Start Date: 2018-01-17 Last Updated: 2018-07-27 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Oropharyngeal Cancer
NCTID: NCT00127088
Title: Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients Study Summary: This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: docetaxel Start Date: 2004-10 Last Updated: 2006-09-11 Number of Patients: 37 Recruitment Status: SUSPENDED Condition: Prostate Cancer
NCTID: NCT04224389
Title: IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas Study Summary: Compare patients’ feelings in terms of swallowing ability assessed by the overall score of MD Anderson Dysphagia Inventory (MDADI) 2 years after starting treatment between patients who have been treated with IMRT and those who were treated by transoral surgery for a squamous cell carcinoma of the early stage oropharynx. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: transoral resection Start Date: 2018-06-22 Last Updated: 2020-02-17 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma
NCTID: NCT01367665
Title: STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Study Summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity. Sponsor: Hoffmann-La Roche Intervention: vismodegib Start Date: 2011-07-01 Last Updated: 2019-06-06 Number of Patients: 1232 Recruitment Status: COMPLETED Condition: Basal Cell Carcinoma
NCTID: NCT04154189
Title: A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma Study Summary: This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma. Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2020-03-23 Last Updated: 2023-10-17 Number of Patients: 81 Recruitment Status: COMPLETED Condition: Osteosarcoma
NCTID: NCT01159288
Title: Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes Study Summary: Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Dex2 Start Date: 2010-05-19 Last Updated: 2018-03-29 Number of Patients: 41 Recruitment Status: COMPLETED Condition: Non Small Cell Lung Cancer
NCTID: NCT00003989
Title: ISIS 3521 in Treating Patients With Advanced, Unresectable, or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or metastatic melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: ISIS 3521 Start Date: 1998-06 Last Updated: 2012-07-11 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT01443065
Title: MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma Study Summary: This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France. Main eligibility criteria include: histologically proven adenocarcinoma of the stomach, esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy. Sponsor: UNICANCER Intervention: Oxaliplatin Start Date: 2011-01 Last Updated: 2020-11-17 Number of Patients: 162 Recruitment Status: COMPLETED Condition: Malignant Neoplasm of Esophagus
NCTID: NCT00005589
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: EBMT Solid Tumors Working Party Intervention: filgrastim Start Date: 1999-10 Last Updated: 2013-09-17 Number of Patients: 460 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT05578872
Title: A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). Study Summary: The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. Sponsor: Anaveon AG Intervention: ANV419 Start Date: 2022-12-16 Last Updated: 2023-08-14 Number of Patients: 130 Recruitment Status: RECRUITING Condition: Melanoma (Skin)
NCTID: NCT01772472
Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. Sponsor: Hoffmann-La Roche Intervention: trastuzumab Start Date: 2013-04-03 Last Updated: 2023-11-13 Number of Patients: 1487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01211938
Title: Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract Study Summary: Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation) Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: single-fraction radiotherapy with concomitant 5FU and Hydrea Start Date: 2010-06-15 Last Updated: 2017-05-16 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma
NCTID: NCT05525338
Title: Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels Study Summary: The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC). The RCT will compare the use of Therapeutic Drug Monitoring (TDM) and dose increases if alectinib 35 ng/Ml (arm A) with standard of care (arm B). Sponsor: University Medical Center Groningen Intervention: Alectinib Start Date: 2022-03-23 Last Updated: 2023-02-21 Number of Patients: 196 Recruitment Status: RECRUITING Condition: Drug Monitoring
NCTID: NCT05203172
Title: The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials Study Summary: The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years. Sponsor: Pfizer Intervention: Binimetinib only treatment Start Date: 2022-07-05 Last Updated: 2023-11-18 Number of Patients: 46 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT05352672
Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: * To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab * To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component * To assess immunogenicity of fianlimab and cemiplimab * To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults * To characterize safety and tolerability of treatment in patients 12 to <18 years of age * To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age * To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab * To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years Sponsor: Regeneron Pharmaceuticals Intervention: Fianlimab Start Date: 2022-07-14 Last Updated: 2023-11-24 Number of Patients: 1590 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT02613962
Title: Proof -of -Concept Study To Stratify Targeted Therapies Adapted To Molecular Profiling Study Summary: In the light of the development of high-throughput technologies enabling a biology-based reclassification of tumors and the increasing number of available specifically targeting anticancer agents the era of “precision medicine” has begun. Several clinical precision medicine trials with the aim of stratifying treatment according to molecular profiles (for example in France: ‘MOlecular Screening for CAncer Treatment Optimization’ MOSCATO-01, SHIVA, PROFILER, Safir01, Safir02) are ongoing in adults and have shown the feasibility of this approach. MOSCATO-01 is the first trial worldwide including pediatric patients, performing an on-purpose intervention and molecular profiling in recurrent tumors. Together with more than 500 adult patients, between December 2012 to August 2014, the tumors of 35 children and adolescents have been profiled, confirming that this approach is feasible in pediatric patients albeit with accelerated time stringencies. Importantly, the results of the first children and adolescents profiled showed that 2/3 of patients had ‘actionable’ alterations using hot spot mutations sequencing and CGH array (Geoerger B et al, ASCO 2014). The project ‘MAPPYACTS’ will use both Whole Exome Sequencing (WES) and RNA Sequencing of tumor tissue to increase the number of targetable genomic alterations. Furthermore to improve understanding of the overall molecular profile and possible response to treatment, methylation array, miRNA expression profiles, and study of immunomodulators will be performed on tumor samples subsequently. CLIP2 (INCa-labeled early phase clinical trials centers) - SiRIC (INCa- labeled comprehensive cancer centers) molecular profiling and bioinformatics platforms will contribute with their expertise in molecular profiling projects and characterization of pediatric cancers. Data interpretation of molecular genetic alterations detected by WES and RNA Seq and treatment recommendation will be done within a multidisciplinary therapeutic molecular biology tumor board. ‘MAPPYACTS’ will produce one of the largest cohorts of molecularly characterized relapsed tumors reported to date, and thanks to increased access to clinical trials since the European pediatric legislation, the investigators expect that 20-30% of patients can be stratified into a targeted trial based on the detected profile. It is the investigators’ intention that this initiative paves the way to enrich ongoing clinical targeted agent trials, to increase the numbers of stratified clinical trials, to an earlier access to targeted agents, and will play a crucial role in the relevant development of these new agents in pediatric malignancies. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: biopsy or surgical resection of tumor and blood sampling Start Date: 2016-01-13 Last Updated: 2020-02-17 Number of Patients: 700 Recruitment Status: UNKNOWN Condition: Relapsed or Refractory Pediatric Tumor
NCTID: NCT03134638
Title: A Study of SY-1365 in Adult Patients With Advanced Solid Tumors Study Summary: This study consists of two parts. Part 1 is a dose-escalation/safety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2. Following the identification of a recommended dose and regimen from Part 1, the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors, and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology. Sponsor: Syros Pharmaceuticals Intervention: SY-1365 (Part 1) Start Date: 2017-05-12 Last Updated: 2021-03-09 Number of Patients: 107 Recruitment Status: TERMINATED Condition: Advanced Solid Tumors
NCTID: NCT05197972
Title: Assessment of Cardiac Coherence Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery Study Summary: The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: cardiac coherence program coupled with hypnosis Start Date: 2022-04-21 Last Updated: 2023-09-14 Number of Patients: 296 Recruitment Status: RECRUITING Condition: Surgery
NCTID: NCT02454062
Title: A Trial of TAS-114 in Combination With S-1 Study Summary: A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors. Sponsor: Taiho Oncology, Inc. Intervention: TAS-114 Start Date: 2013-03 Last Updated: 2020-02-05 Number of Patients: 120 Recruitment Status: COMPLETED Condition: Advanced Solid Tumors
NCTID: NCT03570021
Title: ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer Study Summary: Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group). Pre-registered patients will be randomized before surgery for tumors with class-6 cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen section analysis for tumors with class-5 cytology. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection Start Date: 2018-08-29 Last Updated: 2023-05-19 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Thyroid Cancer
NCTID: NCT01620242
Title: A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes Study Summary: This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes. Sponsor: UNICANCER Intervention: Cabazitaxel Start Date: 2012-04 Last Updated: 2021-03-02 Number of Patients: 31 Recruitment Status: COMPLETED Condition: Recurrent Head and Neck Cancer
NCTID: NCT05005442
Title: A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) Study Summary: The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/vibostolimab coformuation Start Date: 2021-09-28 Last Updated: 2023-09-01 Number of Patients: 180 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hematological Malignancies
NCTID: NCT02242942
Title: Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Study Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years. Sponsor: Hoffmann-La Roche Intervention: Chlorambucil Start Date: 2014-12-31 Last Updated: 2023-09-21 Number of Patients: 445 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphocytic Leukemia, Chronic
NCTID: NCT01482442
Title: SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma Study Summary: The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC) with or without portal venous obstruction and no extrahepatic extension than sorafenib which is now the standard treatment of advanced HCC. Sponsor: Assistance Publique - Hôpitaux de Paris Intervention: sorafenib Start Date: 2011-12 Last Updated: 2017-01-16 Number of Patients: 496 Recruitment Status: COMPLETED Condition: Liver Carcinoma
NCTID: NCT02194842
Title: Phase III Radium 223 mCRPC-PEACE III Study Summary: The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Ra223 Start Date: 2015-10 Last Updated: 2023-03-30 Number of Patients: 446 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT04931342
Title: A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Study Summary: This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase. Sponsor: Hoffmann-La Roche Intervention: Ipatasertib Start Date: 2021-10-07 Last Updated: 2023-11-07 Number of Patients: 550 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT04101331
Title: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides Study Summary: This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients’ health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival. Sponsor: Affimed GmbH Intervention: AFM13 Start Date: 2019-11-13 Last Updated: 2023-08-08 Number of Patients: 108 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT02338531
Title: Biomarker Research Study for PF-03084014 in cHEmoresistant Triple-negative Breast cAncer Study Summary: This is a phase II open label Biomarker Research Study off PF-03084014 in non-metastatic triple-negative breast cancer patients with residual disease (cHEmoresistant) after completion of standard neoadjuvant chemotherapy. Sponsor: Jules Bordet Institute Intervention: PF-03084014 Start Date: 2015-06 Last Updated: 2016-04-29 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Breast Cancer
NCTID: NCT01984242
Title: A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma Study Summary: This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody Start Date: 2014-01-08 Last Updated: 2019-12-23 Number of Patients: 305 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT03505710
Title: DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer Study Summary: The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-05-21 Last Updated: 2023-05-15 Number of Patients: 181 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT05977062
Title: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia Study Summary: Determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional) Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Self screening Start Date: 2022-02-25 Last Updated: 2023-08-04 Number of Patients: 322 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer
NCTID: NCT04842162
Title: Study Evaluating Near-infrared Imaging Coupled With Indocyanin Green for Intraoperative Control of Resection Margins in ENT Surgery Study Summary: Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: indocyanine green Start Date: 2020-12-15 Last Updated: 2021-04-13 Number of Patients: 65 Recruitment Status: UNKNOWN Condition: Head and Neck Cancer
NCTID: NCT05119010
Title: A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma Study Summary: The purpose of this study is to assess objective response rate (partial and complete response) of Nivolumab and Ipilimumab concomitant to a special diet (ketogenic diet, continuous or discontinuous) or standard diet with or without BHB according to RECIST v1.1 at 8 weeks. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Continuous ketogenic diet Start Date: 2023-03-24 Last Updated: 2023-04-05 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT00005062
Title: Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: radiation therapy Start Date: 1999-09 Last Updated: 2014-03-13 Number of Patients: NA Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT00287846
Title: Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis Study Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis. Sponsor: UNICANCER Intervention: imatinib mesylate Start Date: 2004-09 Last Updated: 2016-08-30 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Desmoid Tumor
NCTID: NCT00888810
Title: Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer Study Summary: The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months. Sponsor: Centre Francois Baclesse Intervention: TOPOTECAN Start Date: 2008-03 Last Updated: 2009-04-28 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Cancer
NCTID: NCT05208762
Title: A Study of SGN-PDL1V in Advanced Solid Tumors Study Summary: This study will test the safety of a drug called SGN-PDL1V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have three parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers. Sponsor: Seagen Inc. Intervention: SGN-PDL1V Start Date: 2022-10-25 Last Updated: 2023-10-16 Number of Patients: 315 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT00006112
Title: Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: chemotherapy Start Date: 1996-01 Last Updated: 2011-04-26 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Carcinoma of the Appendix
NCTID: NCT02363751
Title: Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24) Study Summary: Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma. Sponsor: UNICANCER Intervention: Bevacizumab Start Date: 2014-12 Last Updated: 2021-03-09 Number of Patients: 36 Recruitment Status: COMPLETED Condition: Collecting Duct Carcinoma (Kidney)
NCTID: NCT00541112
Title: Radiation Therapy, Chemotherapy, and Cetuximab Followed by Surgery, Chemotherapy, and Cetuximab in Treating Patients With Locally Advanced or Metastatic Rectal Cancer That Can Be Removed by Surgery Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery. Sponsor: UNICANCER Intervention: cetuximab Start Date: 2007-10-29 Last Updated: 2020-02-11 Number of Patients: 19 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT02955251
Title: A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors Study Summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors. Sponsor: AbbVie Intervention: ABBV-428 Start Date: 2016-11-18 Last Updated: 2020-07-20 Number of Patients: 61 Recruitment Status: COMPLETED Condition: Advanced Solid Tumors Cancer
NCTID: NCT02554812
Title: A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) Study Summary: This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications. Sponsor: Pfizer Intervention: Avelumab Start Date: 2015-11-09 Last Updated: 2023-06-23 Number of Patients: 409 Recruitment Status: TERMINATED Condition: Advanced Cancer
NCTID: NCT02839655
Title: Prospective Study Assessing Thyroidectomy Using Robot Study Summary: The robot-assisted surgery for benign and malignant thyroid tumors was widely developed in Asia and begins to spread in Western countries. The main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. It is not surgery minimally invasive but rather a way of remote access surgery. Data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the “gold standard”). However there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no French medico-economic study has been performed. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Da Vinci Xi Start Date: 2016-06-30 Last Updated: 2018-06-15 Number of Patients: 17 Recruitment Status: UNKNOWN Condition: Patients With Thyroid Cancer
NCTID: NCT02523612
Title: Study to Validate a Model of Surgical Deescalation in Atypicals Breast Lesions Study Summary: Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks: # The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer). # These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation. The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance. This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Biopsy Start Date: 2015-06-24 Last Updated: 2018-07-24 Number of Patients: 300 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03164655
Title: Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network Study Summary: National trial, multicenter, randomized, phase II comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still non resectable after at least two months of systemic induction chemotherapy. Sponsor: UNICANCER Intervention: Oxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5-Fluorouracil Start Date: 2018-07-25 Last Updated: 2022-01-04 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Colorectal Cancer Metastatic
NCTID: NCT05267912
Title: Prospective Multicenter Study Evaluating Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers Study Summary: * PDOs are tridimensional multicellular structures expanded in vitro which retain the genotypic and phenotypic features of their tissue or tumor of origin. PDOs can be exposed to a panel of drugs (chemotherapy, hormonal therapy, targeted therapy) in order to study their sensitivity to each agent (or combination of agents) tested (‘chemogram’). Recent studies showed that PDOs can accurately predict the response to treatment of solid tumors and could therefore inform clinical decision on the best therapeutic option for each patient. * ORGANOTREAT is a multicenter prospective study program of organoid-based precision oncology encompassing 3 studies: ORGANOTREAT-01, a pilot study restricted to advanced CRC, and ORGANOTREAT-02A and -2B, two Phase 2 studies in advanced solid cancers. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Biopsy Start Date: 2022-01-19 Last Updated: 2023-05-18 Number of Patients: 1919 Recruitment Status: RECRUITING Condition: Advanced, Pretreated Solid Tumors
