Trials (Candiolo Cancer Institute)
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NCTID: NCT04296890
Title: A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Study Summary: This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab Soravtansine Start Date: 2020-07-23 Last Updated: 2023-07-25 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Epithelial Ovarian Cancer
NCTID: NCT00567190
Title: A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer Study Summary: This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications. Sponsor: Genentech, Inc. Intervention: Pertuzumab Start Date: 2008-02-12 Last Updated: 2019-12-13 Number of Patients: 808 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT03693703
Title: Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer Study Summary: To compare the detection rate of biparametric (bp) magnetic resonance imaging (MRI) for clinically significant prostate cancer (PCa) with that of multiparametric (mp)-MRI, in biopsy-naïve patients. Today, bp-MRI is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-MRI. Its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time. Secondary objectives will be: * to assess specificity of a blood test based on microRNA (miR) score in biopsy-naïve patients, using pathological assessment after MR-guided biopsy as reference standard. If specificity of the miR score is higher than that of PSA, then fewer patients will undergo unnecessary MRI, thus increasing the efficiency of the diagnostic pipeline for PCa; * to develop a clinical decision support system (CDSS) based on MRI and circulating miR evaluation, to stratify patients according to their risk of PCa progression, using pathological assessment after prostatectomy as reference standard. Patients will be stratified into two classes of risk: i) low-risk PCa, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk PCa in which patients should undergo radical treatment (i.e. surgery or radiation therapy). Sponsor: Fondazione del Piemonte per l’Oncologia Intervention: bi-parametric MRI Start Date: 2018-04-18 Last Updated: 2020-08-12 Number of Patients: 391 Recruitment Status: COMPLETED Condition: Prostatic Neoplasm
NCTID: NCT05514054
Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2022-10-04 Last Updated: 2023-10-24 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Breast Neoplasms
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: NCT04221945
Title: Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-05-12 Last Updated: 2023-07-20 Number of Patients: 980 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: NCT05513703
Title: A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. 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 and completing questionnaires. Sponsor: AbbVie Intervention: Telisotuzumab Vedotin Start Date: 2022-11-21 Last Updated: 2023-11-13 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT04622319
Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2020-12-04 Last Updated: 2023-11-07 Number of Patients: 1600 Recruitment Status: RECRUITING Condition: HER2-Positive Primary Breast 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: 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: NCT05254743
Title: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2022-07-22 Last Updated: 2023-10-12 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03555422
Title: Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO] Study Summary: This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2018-01-05 Last Updated: 2023-08-30 Number of Patients: 263 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Cancer
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: 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: 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: NCT04663347
Title: Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) Study Summary: A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL). Sponsor: Genmab Intervention: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone Start Date: 2020-11-03 Last Updated: 2023-08-08 Number of Patients: 662 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT03975647
Title: A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. Sponsor: Seagen Inc. Intervention: tucatinib Start Date: 2019-10-02 Last Updated: 2023-11-21 Number of Patients: 565 Recruitment Status: RECRUITING Condition: HER2-positive Breast 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: NCT02872714
Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) Study Summary: The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations. Sponsor: Incyte Corporation Intervention: pemigatinib Start Date: 2017-01-12 Last Updated: 2023-03-24 Number of Patients: 263 Recruitment Status: COMPLETED Condition: UC (Urothelial Cancer)
NCTID: NCT04145700
Title: CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma Study Summary: This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond. Sponsor: Eli Lilly and Company Intervention: Ramucirumab Start Date: 2020-03-04 Last Updated: 2023-09-13 Number of Patients: 23 Recruitment Status: TERMINATED Condition: Synovial Sarcoma
NCTID: NCT03694522
Title: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer Study Summary: The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer. Sponsor: Five Prime Therapeutics, Inc. Intervention: Bemarituzumab Start Date: 2018-09-14 Last Updated: 2022-12-16 Number of Patients: 155 Recruitment Status: COMPLETED Condition: Gastric Cancer
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: 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: 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: NCT03592472
Title: A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) Study Summary: This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC). Sponsor: Xynomic Pharmaceuticals, Inc. Intervention: Pazopanib Start Date: 2018-07-17 Last Updated: 2022-08-22 Number of Patients: 413 Recruitment Status: RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT04362072
Title: Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer Study Summary: The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment. Participants will take part in this study for up to approximately 4 years, depending on when the study is completed and how their cancer responds to the study treatment. They will take lorlatinib orally (by mouth) once daily. Participants will visit the study site about every six weeks to meet with the study team. During these visits, the study team will monitor the safety and effects of lorlatinib. Sponsor: Pfizer Intervention: Lorlatinib Start Date: 2020-09-29 Last Updated: 2023-07-07 Number of Patients: 71 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: 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: NCT01379989
Title: INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer Study Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Carboplatin Start Date: 2011-06 Last Updated: 2022-02-09 Number of Patients: 617 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04735289
Title: Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma Study Summary: Osteosarcoma and Ewing sarcoma treatment has not changed in the last 30 years. For other types of cancer the epidemiologic and prognostic correlations between dietary behavior, lifestyle and metabolic alterations (i.e.obesity, insulin-resistance) are well known (breast cancer, prostate cancer, colon cancer). However, no epidemiological or prognostic data are available about the metabolic profile and lifestyle behaviors in patients with osteosarcoma and Ewing’sarcoma and only few preclinical studies are available. An in vitro study showed a higher glucose and glutamine consumption from metastatic osteosarcoma cells compared to primary tumor osteosarcoma cells. The effect of the intestinal microbiota into the metabolism of nutrients, drugs, inflammation, epigenetic and immune response was found not only correlated to gastrointestinal tumors but also to other tumors outside gastrointestinal system as well The aim of this study is to investigate if there are differential dietary habits, metabolome, microbiota or immune profile in patients with bone sarcoma compared to a control population in a 1:2 multicenter study. Sponsor: Istituto Ortopedico Rizzoli Intervention: EPIC-COS Food Frequency Questionnaire diet Evaluation Start Date: 2021-03-10 Last Updated: 2023-08-04 Number of Patients: 810 Recruitment Status: RECRUITING Condition: Osteosarcoma
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: NCT04433182
Title: Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma Study Summary: This is a multicentric single arm phase II trial, to investigate the efficacy (in terms of PFS) of the combination regimen rituximab-bendamustine in association with copanlisib in patients affected by relapsed/refractory DLBCL, not eligible to HDC and ASCT or relapsed after intensified regimens. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Copanlisib Start Date: 2020-08-18 Last Updated: 2023-03-31 Number of Patients: 37 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT05101382
Title: A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ) Study Summary: ALFAOMEGA-RETRÒ will be exploited to retrospectively collect clinical and imaging data and archival samples to be used for validation and correlative studies on markers discovered by cutting-edge translational projects within the AIRC5x1000 program “Insights into the evolving heterogeneity of colorectal cancer (CRC): from mechanism to therapies” (an ongoing multi-institutional research program). Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology Intervention: Observation Start Date: 2020-10-28 Last Updated: 2023-03-08 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Colorectal Cancer
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: NCT04680052
Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Study Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-04-15 Last Updated: 2023-08-18 Number of Patients: 654 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT00430352
Title: MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin’s Lymphoma. Study Summary: This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin’s lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. Sponsor: Hoffmann-La Roche Intervention: rituximab [MabThera/Rituxan] Start Date: 2006-09-04 Last Updated: 2017-08-14 Number of Patients: 545 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT03822117
Title: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2019-10-17 Last Updated: 2023-03-20 Number of Patients: 111 Recruitment Status: TERMINATED Condition: Solid Tumor Malignancy
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: NCT03371017
Title: A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer Study Summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-01-11 Last Updated: 2023-11-07 Number of Patients: 572 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT03650517
Title: Minimally Invasive Right Colectomy Anastomosis Study Study Summary: Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon. A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach. However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best. MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study: # Robotic Right Colectomy with ICA # Robotic Right Colectomy with ECA # Laparoscopic Right Colectomy with ICA # Laparoscopic Right Colectomy with ECA All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery. Sponsor: Instituto de Investigación Marqués de Valdecilla Intervention: Extracorporeal Anastomosis Start Date: 2018-11-01 Last Updated: 2019-09-25 Number of Patients: 1200 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT04895709
Title: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors. Sponsor: Bristol-Myers Squibb Intervention: BMS-986340 Start Date: 2021-05-27 Last Updated: 2023-11-13 Number of Patients: 665 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT04729608
Title: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer Study Summary: This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer. Sponsor: Aravive, Inc. Intervention: Batiraxcept Start Date: 2021-04-22 Last Updated: 2023-10-30 Number of Patients: 366 Recruitment Status: TERMINATED Condition: Platinum-resistant Ovarian 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: 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: 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: 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: 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: 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: 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: 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: NCT02275286
Title: Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients Study Summary: Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients: Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma. Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma). Cohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component). Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy/fraction). A translational substudy is developed to analyse different biomarkers predictive value. Cohorts A and B are closed to recruitment in 2023. Sponsor: Grupo Espanol de Investigacion en Sarcomas Intervention: Trabectedin Start Date: 2014-11 Last Updated: 2023-05-31 Number of Patients: 199 Recruitment Status: RECRUITING Condition: Liposarcoma, Myxoid
NCTID: NCT04607421
Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2020-12-21 Last Updated: 2023-09-11 Number of Patients: 815 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT04979442
Title: Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma Study Summary: Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy. Sponsor: Rain Oncology Inc Intervention: RAIN-32 Start Date: 2021-07-14 Last Updated: 2023-10-18 Number of Patients: 175 Recruitment Status: TERMINATED Condition: Dedifferentiated Liposarcoma
NCTID: NCT00781612
Title: A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies Study Summary: This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study. Sponsor: Genentech, Inc. Intervention: Docetaxel Start Date: 2008-10-16 Last Updated: 2023-11-13 Number of Patients: 720 Recruitment Status: RECRUITING Condition: Neoplasm Metastasis
NCTID: NCT02954055
Title: MEtronomic TrEatment Option in Advanced bReast cAncer Study Summary: This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to receive a metronomic regimen of vinorelbine plus cyclophosphamide and capecitabine, or the conventional paclitaxel monotherapy. Sponsor: ETOP IBCSG Partners Foundation Intervention: Paclitaxel Start Date: 2017-09-13 Last Updated: 2022-09-01 Number of Patients: 140 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05409066
Title: Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma Study Summary: Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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 and completing questionnaires. Sponsor: AbbVie Intervention: Epcoritamab Start Date: 2022-09-20 Last Updated: 2023-11-27 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Follicular Lymphoma (FL)
NCTID: NCT05543629
Title: A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer Study Summary: The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants. Sponsor: Bristol-Myers Squibb Intervention: BMS-986442 Start Date: 2022-10-04 Last Updated: 2023-11-15 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT02847429
Title: Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST Study Summary: This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care. Sponsor: Arog Pharmaceuticals, Inc. Intervention: Crenolanib Start Date: 2016-08 Last Updated: 2021-01-22 Number of Patients: 120 Recruitment Status: UNKNOWN Condition: GIST With D842V Mutated PDGFRA Gene
NCTID: NCT03785964
Title: Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) Study Summary: This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). In the double-blind phase, half of the participants will receive nirogacestat while the other half will receive placebo. Once participants are eligible to roll into the open-label phase, they will receive nirogacestat. Sponsor: SpringWorks Therapeutics, Inc. Intervention: Nirogacestat oral tablet Start Date: 2019-04-17 Last Updated: 2023-06-28 Number of Patients: 142 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Desmoid Tumor
NCTID: NCT03654729
Title: Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M) Study Summary: This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin. Sponsor: Egetis Therapeutics Intervention: Calmangafodipir (2 µmol/kg) Start Date: 2018-11-07 Last Updated: 2021-12-17 Number of Patients: 291 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT03273153
Title: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma Study Summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. Sponsor: Hoffmann-La Roche Intervention: Cobimetinib Start Date: 2017-12-11 Last Updated: 2022-09-21 Number of Patients: 446 Recruitment Status: TERMINATED Condition: Advanced BRAFV600 Wild-type Melanoma
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: 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: 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: 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: NCT01358877
Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2011-11-08 Last Updated: 2023-10-04 Number of Patients: 4804 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03522246
Title: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy Study Summary: This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2018-05-14 Last Updated: 2023-09-15 Number of Patients: 1000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Epithelial Ovarian Cancer
NCTID: NCT01702558
Title: A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC) Study Summary: This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2012-12-03 Last Updated: 2021-01-22 Number of Patients: 182 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT03397394
Title: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2018-06-01 Last Updated: 2023-06-09 Number of Patients: 97 Recruitment Status: TERMINATED Condition: Bladder Cancer
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: NCT04093362
Title: Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Study Summary: This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements Sponsor: Taiho Oncology, Inc. Intervention: TAS-120 Start Date: 2020-03-01 Last Updated: 2023-10-11 Number of Patients: 216 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Cholangiocarcinoma
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: NCT04398173
Title: Detection Rate of Prostate Cancer in Men Undergoing MRI Study Summary: To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years. Sponsor: Fondazione del Piemonte per l’Oncologia Intervention: multiparametric MRI Start Date: 2014-11-01 Last Updated: 2021-04-14 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Prostatic Neoplasm
NCTID: NCT04658862
Title: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder Study Summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy. Sponsor: Janssen Research & Development, LLC Intervention: Cetrelimab Start Date: 2020-12-07 Last Updated: 2023-11-07 Number of Patients: 550 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT05999994
Title: A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer Study Summary: The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts. Sponsor: Eli Lilly and Company Intervention: Ramucirumab Start Date: 2020-01-22 Last Updated: 2023-10-18 Number of Patients: 105 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT04398524
Title: A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC Study Summary: This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. Sponsor: ISA Pharmaceuticals Intervention: ISA101b Start Date: 2021-07-01 Last Updated: 2023-04-12 Number of Patients: 86 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Oropharynx
NCTID: NCT04120935
Title: ALFAOMEGA Master Observational Trial Study Summary: AlfaOmega has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improval). This clinical resource for integrative clinical data and sample collection will allow the molecular story-telling of CRC metastatic spread along time and space and the selection of appropriate patients for experimentally-driven trials. Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology Intervention: Observation Start Date: 2019-10-15 Last Updated: 2023-09-28 Number of Patients: 3000 Recruitment Status: RECRUITING Condition: Colorectal 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: NCT06039384
Title: A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation Study Summary: The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. Sponsor: Incyte Corporation Intervention: INCB099280 Start Date: 2024-01-10 Last Updated: 2023-11-24 Number of Patients: 125 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT03125902
Title: A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) Study Summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2017-08-25 Last Updated: 2023-02-15 Number of Patients: 653 Recruitment Status: COMPLETED Condition: Triple-Negative Breast Cancer
NCTID: NCT04569032
Title: A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression Study Summary: This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2020-11-12 Last Updated: 2023-11-14 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Peripheral T-cell Lymphoma
NCTID: NCT02603432
Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-04-25 Last Updated: 2023-06-06 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT03059823
Title: A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors Study Summary: The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort. Sponsor: Incyte Corporation Intervention: retifanlimab Start Date: 2016-11-15 Last Updated: 2023-07-12 Number of Patients: 325 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced Solid Tumors
NCTID: NCT04704934
Title: Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) Study Summary: This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2021-05-21 Last Updated: 2023-09-07 Number of Patients: 490 Recruitment Status: RECRUITING Condition: Gastric Cancer, Adenocarcinoma
NCTID: NCT04578444
Title: An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer Study Summary: This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab. Sponsor: Jazz Pharmaceuticals Intervention: Zanidatamab Start Date: NA Last Updated: 2023-09-01 Number of Patients: NA Recruitment Status: AVAILABLE Condition: HER2-Positive Advanced Biliary Tract Cancer
NCTID: NCT02517398
Title: MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Study Summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: MSB0011359C Start Date: 2015-08-31 Last Updated: 2022-06-15 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT03277924
Title: Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas Study Summary: Phase I-II, single-arm, non-randomized, open-label, multicenter, international clinical trial, with eight cohorts (DDCS, EMC, VS, SFT, CCS, ASPS, UPS, LMS and OS). Nine sites in Spain, 3 sites in Italy and 1 site in the United Kingdom. C1 to 6 Objective: To evaluate the efficacy of the sunitinib plus nivolumab combination as measured by PFSR at 6 months (CS/DDCS, EMC, VS, SFT, CCS cohorts) and at 12 months (ASPS cohort). Treatment: Adult patients will receive an initial induction phase (IP) from day 1 to day 14 of sunitinib 37.5 mg/day followed by a maintenance phase (MP) of sunitinib 25mg/day continuously + nivolumab 240mg every 2 weeks. Pediatric patients will receive an initial IP from day 1 to day 14 of (<18 years) sunitinib at 25 mg/day unless the body surface area (BSA) of the patient is >1.7. If BSA is >1.7, then sunitinib 37.5 mg/day will be given followed by a MP of sunitinib 25 mg/day continuously + nivolumab 240 mg every 2 weeks regimen (if weight ≥40 kg) or sunitinib 25 mg/day continuously + nivolumab 3 mg/kg every 2 weeks regimen (if weight <40kg). Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision. C 7 Objective: To determine the MTD of the epirubicin + ifosfamide + nivolumab combination in undifferentiated pleomorphic sarcoma and of the doxorubicin + dacarbazine + nivolumab combination in leiomyosarcoma. Treatment: Cohort 7a dose level 0: Patients will receive epirubicin dose of 60 mg/m2/d, d1 and d2 IV 20 minutes; followed by ifosfamide 3 g/m2/d d1-3, IV 3h with MESNA protection (40% of total dose of ifosfamide in each administration at 0, 3 and 6 h from ifosfamide initiation). Once finished Ifosfamide infusion of day 3, nivolumab is administered during 30 minutes, at dose of 360 mg IV, Q3W. GCSF support is mandatory. One-year maintenance of nivolumab is foreseen in the absence of progressive disease. If three or more DLTs occur nivolumab dose will be lowered to dose level -1 where patients will receive epirubicin dose of 60 mg/m2/d, d1 and d2 IV 20 minutes; followed by ifosfamide 3 g/m2/d d1-3, IV 3h with MESNA protection (40% of total dose of ifosfamide in each administration at 0, 3 and 6 h from ifosfamide initiation). Once finished Ifosfamide infusion of day 3, nivolumab is administered during 30 minutes, at dose of 240 mg IV, Q3W. GCSF support is mandatory. One-year maintenance of nivolumab is foreseen in the absence of progressive disease. Cohort 7b dose level 0: Patients will receive doxorubicin at dose of 75 mg/m2/d, d1 IV 20 minutes; followed by dacarbazine 400 mg//m2/d IV 60 minutes. Dacarbazine is administered also on day 2 of cycle. Once finished Dacarbazine infusion of day 2, nivolumab is administered for 30 minutes, at dose of 360 mg IV, Q3W. GCSF support is mandatory. One-year maintenance of nivolumab is foreseen in the absence of progressive disease. If three or more DLTs occur nivolumab dose will be lowered to dose level -1 where patients will receive doxorubicin at dose of 75 mg/m2/d, d1 IV 20 minutes; followed by dacarbazine 400 mg//m2/d IV 60 minutes. Dacarbazine is administered also on day 2 of cycle. Once finished dacarbazine infusion of day 2, nivolumab is administered for 30 minutes, at dose of 240 mg IV, Q3W. GCSF support is mandatory. One-year maintenance of nivolumab is foreseen in the absence of progressive disease. C 8 Objectives:To determine the MTD of the MAP + nivolumab combination (phase I). Proportion of patients achieving good pathological response (phase II) Treatment dose level 0: In the IP, patients will receive CDDP 120 mg/m2 in 48h IV infusion (days 1-2) followed by doxorubicin 75 mg/m2 in 48h IV infusion (days 3-4). CDDP and doxorubicin will be given on days 1-4 and 36-39. Nivolumab administration will start on day 4 at flat dose 240 mg (after the end of doxorubicin), being the following doses administered on days 18, 39, and 53 (240 mg). HD methotrexate at 12 g/m2 in 2-h infusion will be administered on days 22, 29, 57, and 64. Surgery will be performed after finishing IP. Adjuvant chemotherapy will be administered after surgery. During the MP patients will receive nivolumab on day 210, every two weeks up to day 364. If three or more DLTs occur, then nivolumab dose level -1 will be activated where patients will receive MAP during the IP (same as described for level 0), but the dose of nivolumab will be 360 mg on days 4 and 36. Surgery will be performed after finishing IP. Adjuvant chemotherapy will be administered after surgery. During the MP patients will receive nivolumab on day 210, every three weeks up to day 364. Sponsor: Grupo Espanol de Investigacion en Sarcomas Intervention: Sunitinib 37.5 MG, Sunitinib 25 MG [Sutent] Start Date: 2017-05-31 Last Updated: 2023-07-17 Number of Patients: 270 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT02855944
Title: ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Study Summary: The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy. Sponsor: pharmaand GmbH Intervention: Chemotherapy Start Date: 2017-03-01 Last Updated: 2023-06-09 Number of Patients: 349 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03656536
Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2019-06-03 Last Updated: 2023-11-15 Number of Patients: 434 Recruitment Status: RECRUITING Condition: Unresectable Cholangiocarcinoma
NCTID: NCT05287113
Title: Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Study Summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). Sponsor: Incyte Biosciences International Sàrl Intervention: Retifanlimab Start Date: 2022-11-14 Last Updated: 2023-11-09 Number of Patients: 162 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT02678481
Title: MR-targeted vs. Random TRUS-guided Prostate Biopsy Study Summary: To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be randomized (1:1) into the two study arms. Sponsor: Fondazione del Piemonte per l’Oncologia Intervention: MR-guided in-bore prostate biopsy Start Date: 2014-11 Last Updated: 2016-08-22 Number of Patients: 90 Recruitment Status: UNKNOWN Condition: Prostate Cancer
NCTID: NCT05578976
Title: A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. 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: Epcoritamab Start Date: 2023-02-08 Last Updated: 2023-11-29 Number of Patients: 900 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT03599713
Title: A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201) Study Summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC). Sponsor: Incyte Corporation Intervention: Retifanlimab Start Date: 2019-02-25 Last Updated: 2023-10-26 Number of Patients: 107 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Merkel Cell Carcinoma
NCTID: NCT04871399
Title: Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer Study Summary: An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy. Sponsor: University of Turin, Italy Intervention: Conventional Right hemicolectomy (Non-CME) Start Date: 2020-07-13 Last Updated: 2022-11-14 Number of Patients: 416 Recruitment Status: RECRUITING Condition: Colon Cancer
NCTID: NCT02989857
Title: Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) Study Summary: Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants’ response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen. Sponsor: Institut de Recherches Internationales Servier Intervention: AG-120 Start Date: 2017-02-20 Last Updated: 2023-01-17 Number of Patients: 187 Recruitment Status: COMPLETED Condition: Advanced Cholangiocarcinoma
NCTID: NCT03210298
Title: International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) Study Summary: Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria. Sponsor: Sabine Rhode Intervention: PIPAC Start Date: 2016-01 Last Updated: 2019-10-08 Number of Patients: 1000 Recruitment Status: UNKNOWN Condition: Peritoneum Cancer
NCTID: NCT05218499
Title: Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma Study Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check 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: BI 907828 Start Date: 2022-03-25 Last Updated: 2023-11-07 Number of Patients: 400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Liposarcoma, Dedifferentiated
NCTID: NCT04338399
Title: The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC Study Summary: The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy. Sponsor: Adlai Nortye Biopharma Co., Ltd. Intervention: Buparlisib & Paclitaxel Start Date: 2020-12-12 Last Updated: 2023-11-02 Number of Patients: 483 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Cancer
NCTID: NCT04526899
Title: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma Study Summary: This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent. Sponsor: BioNTech SE Intervention: BNT111 Start Date: 2021-05-19 Last Updated: 2023-11-28 Number of Patients: 184 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma Stage III
NCTID: NCT02492711
Title: Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Study Summary: The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy. Sponsor: MacroGenics Intervention: Margetuximab Start Date: 2015-08-24 Last Updated: 2022-11-23 Number of Patients: 624 Recruitment Status: COMPLETED Condition: HER-2 Positive Breast Cancer
