Trials (Fondazione Policlinico Universitario Agostino Gemelli IRCCS)
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NCTID: NCT05323656
Title: A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) Study Summary: The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab. Sponsor: Calliditas Therapeutics Suisse SA Intervention: Setanaxib Start Date: 2022-04-06 Last Updated: 2023-11-29 Number of Patients: 55 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT05291156
Title: CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy Study Summary: This is a non-profit phase II, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy, compared to cetuximab alone, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment. Sponsor: University of Campania “Luigi Vanvitelli” Intervention: Cetuximab Start Date: 2022-07-21 Last Updated: 2023-10-04 Number of Patients: 173 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT05802290
Title: NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN Study Summary: Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent. This study is designed to better evaluate the safety profile of nivolumab in a large series of patients with Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck. The primary endpoint of this study is the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Nivolumab 240 MG in 24 ML Injection Start Date: 2017-11-27 Last Updated: 2023-04-06 Number of Patients: 124 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04576156
Title: A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment Study Summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment. Sponsor: Geron Corporation Intervention: Imetelstat Start Date: 2021-04-12 Last Updated: 2023-11-28 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Myelofibrosis
NCTID: NCT04034056
Title: Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN) Study Summary: To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy. Sponsor: Hoffmann-La Roche Intervention: Obinutuzumab Start Date: 2019-09-02 Last Updated: 2023-10-04 Number of Patients: 299 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT04987203
Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Study Summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib Start Date: 2021-09-09 Last Updated: 2023-11-28 Number of Patients: 326 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT04607668
Title: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): Study Summary: This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease. Sponsor: G1 Therapeutics, Inc. Intervention: Trilaciclib Start Date: 2020-10-16 Last Updated: 2023-04-07 Number of Patients: 326 Recruitment Status: TERMINATED Condition: Colorectal Cancer Metastatic
NCTID: NCT05317416
Title: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant Study Summary: The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years Sponsor: Pfizer Intervention: Elranatamab Start Date: 2022-03-25 Last Updated: 2023-11-28 Number of Patients: 760 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT05804682
Title: Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma Study Summary: Optimal surgical technique for neck dissection (LND) in thyroid carcinoma remains a subject of debate. Fascial ND (FND) implies the removal of the superficial and middle layers of the deep cervical fascia en bloc with lymph-nodes containing fibro-fatty tissue (levels IIa-Vb and VI-VII for cN1b patients). This retrospective cohort study was designed to compare FND with standard, non-fascial, selective ND (SND). Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Fascial Neck Dissection Start Date: 2018-01-01 Last Updated: 2023-04-07 Number of Patients: 195 Recruitment Status: COMPLETED Condition: Patients With Papillary Thyroid Cancer and N1b Status
NCTID: NCT04458259
Title: Study of PF-07265807 in Participants With Metastatic Solid Tumors. Study Summary: A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors Sponsor: Pfizer Intervention: PF-07265807 Start Date: 2020-09-24 Last Updated: 2023-11-22 Number of Patients: 67 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neoplasm Metastasis
NCTID: NCT05876754
Title: An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma Study Summary: A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle. Sponsor: Servier Affaires Médicales Intervention: Ivosidenib Oral Tablet Start Date: 2023-05-03 Last Updated: 2023-09-06 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Cholangiocarcinoma
NCTID: NCT03815643
Title: Avelumab Program Rollover Study Study Summary: The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2019-03-22 Last Updated: 2023-11-07 Number of Patients: 161 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT03257267
Title: Study of Cemiplimab in Adults With Cervical Cancer Study Summary: The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator’s choice (IC) chemotherapy. The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are: * To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy * To compare objective response rate (ORR) (partial response <math display="block">PR</math> + complete response <math display="block">CR</math>) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy * To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE) * To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Sponsor: Regeneron Pharmaceuticals Intervention: Cemiplimab Start Date: 2017-09-05 Last Updated: 2023-07-11 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma (SCC)
NCTID: NCT03414047
Title: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer Study Summary: The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer. Sponsor: Eli Lilly and Company Intervention: Prexasertib Start Date: 2018-04-10 Last Updated: 2022-08-19 Number of Patients: 172 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04582487
Title: Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL Study Summary: This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data. As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of identified compound. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: bone marrow and/or peripheral blood samples withdrawal Start Date: 2021-05-19 Last Updated: 2022-11-28 Number of Patients: 32 Recruitment Status: RECRUITING Condition: T Acute Lymphoblastic Leukemia
NCTID: NCT01074047
Title: Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) Study Summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients. Sponsor: Celgene Intervention: Azacitidine Start Date: 2010-06-01 Last Updated: 2017-08-29 Number of Patients: 488 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT05750719
Title: BRCA and NACT in TNBC Patients Study Summary: The goal of this observational study is to evaluate data from patients with triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NACT) in order to better define the impact of germline BRCA1/2 (gBRCA1/2) mutation status on outcomes in this patient population. The aims of the study are: * To evaluate the rate of pathologic complete response (pCR) in patients with locally advanced TNBC who performed NACT, in relation to the mutational status of gBRCA. * To evaluate Evaluate Event Free survival (EFS) and Overall Survival (OS) in this patients population. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: BRCA1/2 genetic testing Start Date: 2013-01-02 Last Updated: 2023-03-02 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Triple-Negative Breast Cancer
NCTID: NCT05896566
Title: A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer Study Summary: PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C). Sponsor: ETOP IBCSG Partners Foundation Intervention: Giredestrant Start Date: 2023-12-01 Last Updated: 2023-10-18 Number of Patients: 220 Recruitment Status: NOT_YET_RECRUITING Condition: Breast Cancer
NCTID: NCT04460807
Title: Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer Study Summary: In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS). Sponsor: Ente Ospedaliero Ospedali Galliera Intervention: Exemestane Start Date: 2020-02-13 Last Updated: 2020-07-08 Number of Patients: 468 Recruitment Status: UNKNOWN Condition: Ovarian Cancer
NCTID: NCT03635567
Title: Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-10-25 Last Updated: 2023-11-14 Number of Patients: 617 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cervical Cancer
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-29 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT06059547
Title: Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer Study Summary: This is a multi-center, stratified and single-blinded Phase 2 study of neoadjuvant immunotherapy in combination with the antiGDF15 antibody visugromab (CTL-002) for the treatment of subjects with MIBC set to undergo radical Cystectomy (RC) who cannot receive or refuse to receive cisplatin-based chemotherapy. Sponsor: CatalYm GmbH Intervention: Nivolumab Start Date: 2023-09-06 Last Updated: 2023-09-28 Number of Patients: 30 Recruitment Status: RECRUITING Condition: Bladder Cancer
NCTID: NCT04951622
Title: A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis Study Summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). Sponsor: Janssen Research & Development, LLC Intervention: Nipocalimab Start Date: 2021-07-15 Last Updated: 2023-11-09 Number of Patients: 198 Recruitment Status: RECRUITING Condition: Myasthenia Gravis
NCTID: NCT03336333
Title: A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL Study Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2017-10-31 Last Updated: 2023-11-09 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
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: NCT04161885
Title: A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML) Study Summary: The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B). Sponsor: AbbVie Intervention: Venetoclax Start Date: 2020-02-26 Last Updated: 2023-11-14 Number of Patients: 424 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT05173987
Title: Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) Study Summary: The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2022-02-03 Last Updated: 2023-11-09 Number of Patients: 280 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT05706883
Title: Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC) Study Summary: Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes Start Date: 2023-01-01 Last Updated: 2023-10-23 Number of Patients: 168 Recruitment Status: RECRUITING Condition: Lung Cancer Metastatic
NCTID: NCT05953883
Title: PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER Study Summary: Proteogenomic analysis to detect individual platinum-induced modifications on tumor tissue of HGSC according to chemotherapy response score (CRS), using a combined approach of High resolution liquid chromatography mass Spectrometry based platform (HR-LC-MS/MS and advanced immunometric methods on illumine platform); multiple supervised machine learning algorithms will be used to discover proteogenomic signatures and biological processes associated with platinum modification during the neoadjuvant chemotherapy treatment. These results contribute to precision medicine by building an accurate proteogenomic profile of ovarian cancer, in order to better understand the underlying mechanisms of different chemotherapy response among affected patients. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Tumor and blood sample Start Date: 2022-11-17 Last Updated: 2023-07-20 Number of Patients: 24 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT04674683
Title: Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma Study Summary: This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level. Sponsor: HUYABIO International, LLC. Intervention: HBI-8000 in combination with nivolumab Start Date: 2021-08-12 Last Updated: 2023-07-27 Number of Patients: 480 Recruitment Status: RECRUITING Condition: Unresectable or Metastatic Melanoma
NCTID: NCT01358071
Title: Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer Study Summary: The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF Start Date: 2011-06 Last Updated: 2018-09-27 Number of Patients: 119 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT05238922
Title: Study of INCB123667 in Subjects With Advanced Solid Tumors Study Summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. Sponsor: Incyte Corporation Intervention: INCB0123667 Start Date: 2022-07-05 Last Updated: 2023-11-03 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT03705403
Title: IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study Study Summary: This will be a phase II trial testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC). The trial consists of one cohort with two arms; C-arm and an E-arm. Patients with oligometastatic disease will receive SABR to minimal 1 and max all metastatic sites (max 5 sites irradiated) and patients with diffuse metastatic lesions (6 to max 10) will receive radiotherapy to max 5 sites. In the experimental arm, immunotherapy will be given after irradiation. Sponsor: Maastricht University Intervention: Darleukin Start Date: 2019-04-04 Last Updated: 2020-10-20 Number of Patients: 126 Recruitment Status: RECRUITING Condition: NSCLC Stage IV
NCTID: NCT03760003
Title: Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Study Summary: Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis. Sponsor: Abivax S.A. Intervention: ABX464 25mg Start Date: 2019-09-23 Last Updated: 2021-08-02 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Ulcerative Colitis
NCTID: NCT05257083
Title: A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients. Sponsor: European Myeloma Network Intervention: Daratumumab Start Date: 2023-10-10 Last Updated: 2023-11-18 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT03940703
Title: A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) Study Summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Tepotinib Start Date: 2019-09-19 Last Updated: 2023-08-29 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT04733183
Title: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma Study Summary: Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma. Sponsor: Philogen S.p.A. Intervention: Dacarbazine Start Date: 2020-08-28 Last Updated: 2023-10-10 Number of Patients: 98 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT03394365
Title: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy Study Summary: The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. Sponsor: Atara Biotherapeutics Intervention: tabelecleucel Start Date: 2017-12-29 Last Updated: 2022-06-24 Number of Patients: 66 Recruitment Status: RECRUITING Condition: Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
NCTID: NCT02395172
Title: Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) Study Summary: The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-03-24 Last Updated: 2020-08-03 Number of Patients: 792 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04666038
Title: Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: LOXO-305 Start Date: 2021-03-09 Last Updated: 2023-11-01 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04484142
Title: Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) Study Summary: This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-1062a Start Date: 2021-03-30 Last Updated: 2023-11-14 Number of Patients: 137 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT05062889
Title: Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients Study Summary: The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: 5-Fluorouracil continuous infusion FOLFOXIRI schedule Start Date: 2023-05-17 Last Updated: 2023-06-29 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Stage II Colon Cancer
NCTID: NCT02291289
Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. Sponsor: Hoffmann-La Roche Intervention: Cetuximab Start Date: 2015-04-17 Last Updated: 2021-05-26 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03517449
Title: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician’s Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) Study Summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician’s choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician’s choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician’s choice. Sponsor: Eisai Inc. Intervention: Pembrolizumab Start Date: 2018-06-11 Last Updated: 2023-10-18 Number of Patients: 827 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT03834493
Title: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-07-28 Last Updated: 2023-06-15 Number of Patients: 1244 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostatic Neoplasms
NCTID: NCT05808816
Title: “Lactobacillus Crispatus M247, LSIL and Microbiota” Study Summary: Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Lactobacillus Crispatus M247 Start Date: 2021-06-16 Last Updated: 2023-04-11 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Vaginal Flora Imbalance
NCTID: NCT02725268
Title: A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer Study Summary: The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Paclitaxel Start Date: 2016-04-01 Last Updated: 2021-11-24 Number of Patients: 241 Recruitment Status: COMPLETED Condition: Endometrial Neoplasms
NCTID: NCT03410693
Title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied. Sponsor: Bayer Intervention: Rogaratinib (BAY1163877) Start Date: 2018-05-31 Last Updated: 2022-09-28 Number of Patients: 175 Recruitment Status: COMPLETED Condition: Carcinoma, Transitional Cell
NCTID: NCT05850520
Title: A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) Study Summary: Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: * adverse events * serious adverse events “Adverse events” are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered “serious” when it leads to death, puts the participants’ lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: * check patients’ eye health using various eye examination techniques * measure patients’ eye vision (BCVA) * take blood and urine samples * do physical examinations * check vital signs * examine heart health using electrocardiogram (ECG) * do pregnancy tests in women of childbearing age In addition, participants will be asked to fill a questionnaire on vision-related quality of life. Sponsor: Bayer Intervention: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Start Date: 2023-05-15 Last Updated: 2023-11-28 Number of Patients: 822 Recruitment Status: RECRUITING Condition: Macular Edema Secondary to Retinal Vein Occlusion
NCTID: NCT05750693
Title: PIK3CA in HER2+ BC and pCR Trial Study Summary: The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS. * Is there a correlation between PIK3CA mutations and response to neoadjuvant chemotherapy in HER2 early breast cancer? Participants who received neoadjuvant chemotherapy in addition to anti-Her2 target therapy will undergo PIK3CA analysis in order to answer to this question. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: PIK3CA analysis Start Date: 2022-05-02 Last Updated: 2023-03-02 Number of Patients: 58 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HER2-positive Breast Cancer
NCTID: NCT04965493
Title: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-09-20 Last Updated: 2023-10-12 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03914820
Title: Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study. Study Summary: This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility. Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center Sponsor: Mario Negri Institute for Pharmacological Research Intervention: HIPEC CO2 surgery Start Date: 2020-06-19 Last Updated: 2023-10-27 Number of Patients: 330 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT01507168
Title: A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma Study Summary: This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Sponsor: Hoffmann-La Roche Intervention: Placebo Start Date: 2012-02-02 Last Updated: 2020-04-03 Number of Patients: 185 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
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: NCT04589845
Title: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Study Summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Entrectinib Start Date: 2021-01-18 Last Updated: 2023-11-13 Number of Patients: 920 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT03277105
Title: A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough). Sponsor: Janssen Research & Development, LLC Intervention: Dara SC Start Date: 2017-10-27 Last Updated: 2023-10-11 Number of Patients: 522 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT02993705
Title: Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS) Study Summary: Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Trabectedin Start Date: 2017-02-22 Last Updated: 2021-08-25 Number of Patients: 45 Recruitment Status: COMPLETED Condition: Carcinosarcoma, Ovarian
NCTID: NCT04646005
Title: Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy Study Summary: The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: * To characterize the safety profile of cemiplimab + ISA101b * To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS) Sponsor: Regeneron Pharmaceuticals Intervention: Cemiplimab Start Date: 2021-06-28 Last Updated: 2023-10-03 Number of Patients: 113 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cervical Cancer
NCTID: NCT06076005
Title: Lung Cancer ID (Identity) Study Study Summary: The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Advanced lung cancer patients’ group Start Date: 2023-11-01 Last Updated: 2023-10-17 Number of Patients: 1000 Recruitment Status: NOT_YET_RECRUITING Condition: Lung Cancer Stage IV
NCTID: NCT03455517
Title: Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia Study Summary: Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and patients with a particular characteristic known as ‘disrupted TP53’ show an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Venetoclax Start Date: 2018-10-31 Last Updated: 2023-11-24 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT03662126
Title: KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to “cross-over” to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2019-01-15 Last Updated: 2023-04-28 Number of Patients: 385 Recruitment Status: RECRUITING Condition: Primary Myelofibrosis (PMF)
NCTID: NCT04656652
Title: Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-1062a Start Date: 2020-12-21 Last Updated: 2023-11-18 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT03565991
Title: Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors Study Summary: Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect. Sponsor: Pfizer Intervention: Avelumab Start Date: 2018-06-18 Last Updated: 2023-09-25 Number of Patients: 202 Recruitment Status: TERMINATED Condition: Locally Advanced or Metastatic Solid Tumors
NCTID: NCT04181827
Title: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). Sponsor: Janssen Research & Development, LLC Intervention: JNJ-68284528 Start Date: 2020-06-12 Last Updated: 2023-11-09 Number of Patients: 419 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT04032704
Title: A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Study Summary: This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer. Sponsor: Seagen Inc. Intervention: ladiratuzumab vedotin Start Date: 2019-10-09 Last Updated: 2023-07-14 Number of Patients: 205 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT03751917
Title: Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia Study Summary: The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough information on the incidence of long-term side effects. This study, as well as other similar studies conducted around Europe, will focus on following patients treated with this therapy on a long-term basis. Once all studies in Europe will be concluded, all data will be analyzed together. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Arsenic Trioxide Start Date: 2020-04-14 Last Updated: 2022-01-04 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Acute Promyelocytic Leukemia
NCTID: NCT04498117
Title: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery Study Summary: Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking. Sponsor: CanariaBio Inc. Intervention: Oregovomab Start Date: 2020-08-25 Last Updated: 2023-10-10 Number of Patients: 615 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Ovarian Epithelial
NCTID: NCT02039726
Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive Study Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Quizartinib Start Date: 2014-05 Last Updated: 2021-02-24 Number of Patients: 367 Recruitment Status: COMPLETED Condition: AML
NCTID: NCT05769517
Title: PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES Study Summary: The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Retrospective phase AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Prospective phase AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Germinal BRCA Start Date: 2023-03-20 Last Updated: 2023-06-22 Number of Patients: 1300 Recruitment Status: RECRUITING Condition: BRCA Mutation
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: NCT03045406
Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer Study Summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study Sponsor: Fadoi Foundation, Italy Intervention: Apixaban Start Date: 2017-04-13 Last Updated: 2019-11-14 Number of Patients: 1168 Recruitment Status: UNKNOWN Condition: Venous Thromboembolism
NCTID: NCT03866109
Title: A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT Study Summary: This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment. Sponsor: Genenta Science Intervention: Temferon Start Date: 2019-03-05 Last Updated: 2023-01-20 Number of Patients: 27 Recruitment Status: RECRUITING Condition: Glioblastoma Multiforme
NCTID: NCT05176691
Title: HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL Study Summary: An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL Sponsor: Hutchmed Intervention: HMPL-760 Start Date: 2022-02-15 Last Updated: 2023-02-21 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: CLL/SLL
NCTID: NCT04463771
Title: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. Study Summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents. Sponsor: Incyte Corporation Intervention: retifanlimab Start Date: 2021-01-26 Last Updated: 2023-10-26 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT02928406
Title: A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract Study Summary: This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-11-30 Last Updated: 2022-12-22 Number of Patients: 1005 Recruitment Status: COMPLETED Condition: Urinary Tract Cancer
NCTID: NCT03726879
Title: A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer Study Summary: This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-01-11 Last Updated: 2023-09-25 Number of Patients: 454 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT05259839
Title: A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma Study Summary: Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide. Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro in 28-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: TeneoOne Inc. Intervention: ABBV-383 Start Date: 2022-10-20 Last Updated: 2023-10-23 Number of Patients: 270 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Multiple Myeloma
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT05007106
Title: MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Study Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2021-09-16 Last Updated: 2023-11-24 Number of Patients: 610 Recruitment Status: RECRUITING Condition: Uterine Cervical Neoplasms
NCTID: 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: NCT04028050
Title: A Study of Atezolizumab in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer Study Summary: This is a phase IIIB, single-arm, single-country, multicenter study of the safety and efficacy of atezolizumab in combination with carboplatin plus etoposide in patients who have ES-SCLC and are chemotherapy-naive for their extensive-stage disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-08-12 Last Updated: 2023-07-24 Number of Patients: 155 Recruitment Status: COMPLETED Condition: Small Cell Lung Carcinoma
NCTID: NCT06057168
Title: Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas Study Summary: This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas. Sponsor: Guerbet Intervention: Elucirem Start Date: 2023-09-07 Last Updated: 2023-09-28 Number of Patients: 138 Recruitment Status: RECRUITING Condition: Brain Tumor, Primary
NCTID: NCT02793050
Title: Retrospective Study of Trabectedin in Soft Tissue Sarcomas Study Summary: This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting. A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug. Sponsor: Italian Sarcoma Group Intervention: Trabectedin Start Date: 2016-06-15 Last Updated: 2019-05-10 Number of Patients: 510 Recruitment Status: COMPLETED Condition: Sarcoma, Soft Tissue
NCTID: NCT04041050
Title: A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm Study Summary: There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib. Sponsor: AbbVie Intervention: Navitoclax Start Date: 2019-11-08 Last Updated: 2023-05-16 Number of Patients: 85 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myeloproliferative Neoplasm
NCTID: NCT03410407
Title: Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML) Study Summary: The present study aims at evaluating the prognostic factors at diagnosis predicting Central Nervous System (CNS) relapse in order to identify a group of patients with higher risk of CNS involvement in which prophylaxis with liposomal Ara-C or other drugs should be indicated. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Observation of CNS involvement Start Date: 2019-03-19 Last Updated: 2022-10-26 Number of Patients: 21 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT04487067
Title: A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista Study Summary: This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-08-25 Last Updated: 2023-11-21 Number of Patients: 152 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT05587296
Title: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer Study Summary: Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment. To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment. The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant. All participants will continue taking the anti-cancer therapy they have been using when entering the study. Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks. Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152. During the study, the participants will: * record information about their hot flashes * answer questions about their quality of life and other symptoms. The doctors and their study team will: * check the participants health and vital signs * take blood and urine samples * examine heart health using electrocardiogram (ECG) * examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs * make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable) * check the health of the participant’s cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable) * take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis. * ask the participants questions about what medicines they are taking and if they are having adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants’ health. Sponsor: Bayer Intervention: Elinzanetant (BAY3427080) Start Date: 2022-10-14 Last Updated: 2023-11-13 Number of Patients: 405 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
NCTID: NCT02864030
Title: PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment Study Summary: On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated. Sponsor: Oncologia Medica dell’Ospedale Fatebenefratelli Intervention: ERIBULIN MESYLATE Start Date: 2014-05 Last Updated: 2021-03-04 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04272931
Title: DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE Study Summary: Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2). Sponsor: Maastricht University Intervention: Portal and Hepatic Vein Embolization Start Date: 2020-05-08 Last Updated: 2023-02-03 Number of Patients: 111 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer Liver Metastases
NCTID: NCT02576431
Title: A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors Study Summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. Sponsor: Bayer Intervention: BAY2757556 (Larotrectinib, Vitrakvi) Start Date: 2015-09-30 Last Updated: 2023-11-07 Number of Patients: 204 Recruitment Status: RECRUITING Condition: Solid Tumors Harboring NTRK Fusion
NCTID: NCT01728155
Title: European Low and Intermediate Risk Neuroblastoma Protocol
Study Summary: The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with “non high risk” neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours. # LOW RISK STUDY The Low Risk Study is proposed in order to:
minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).
improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms.
- INTERMEDIATE RISK STUDY
The Intermediate Risk Study is proposed in order to: * reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome; * increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study; * improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment; * maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment. NEONATAL SUPRARENAL MASSES The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation
Sponsor: Instituto de Investigacion Sanitaria La Fe Intervention: chemotherapy Start Date: 2011-01-01 Last Updated: 2023-09-08 Number of Patients: 685 Recruitment Status: COMPLETED Condition: LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
NCTID: NCT05327530
Title: A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) Study Summary: The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2022-08-17 Last Updated: 2023-10-23 Number of Patients: 252 Recruitment Status: RECRUITING Condition: Locally Advanced or Metastatic Urothelial Carcinoma
NCTID: NCT04380766
Title: Covid-19 Pandemic and Pancreatic Surgery in Italy Study Summary: Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer Start Date: 2019-01-01 Last Updated: 2020-08-03 Number of Patients: 730 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT04551066
Title: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) Study Summary: The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis. Sponsor: Incyte Corporation Intervention: parsaclisib Start Date: 2021-05-27 Last Updated: 2023-10-06 Number of Patients: 252 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT06071286
Title: SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS Study Summary: Ovarian cancer (OC) is the third most common gynaecologic cancer worldwide and has the highest mortality rate among gynaecologic cancers. Despite the advances in cytoreductive surgery and frontline chemotherapy, recurrence is a common event in the advanced disease setting, with more than 70% of women experiencing relapse within two years from diagnosis. New strategies to anticipate the diagnosis of recurrence have been investigated in the last years. In this context, standard serum biomarkers, such as CA-125, and radiological evaluation are commonly used for disease surveillance, However, the early identification of relapsed disease as well as the identification of patients at higher risk for recurrence are still unmetclinical needs. Novel and reliable molecular biomarkers, which might also better represent the intrinsic molecular complexity of OC, could help clinicians to address this important challenge. Circulating tumor DNA (ctDNA) analysis has recently emerged as a non-invasive tool to profile and monitor tumor evolution over time. CtDNA has been extensively studied in several neoplasms in order to evaluate its ability in anticipating detection of relapse compared to common markers used in clinical practice. Wehave designed a study to assess the ability of ctDNA to detect recurrence and progression of disease and to provide a genomic characterization, during follow-up of patients with advanced OC. If proven effective and reliable, ctDNA could be introduced into routine surveillance programme for OC. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Blood samples Start Date: 2023-11-01 Last Updated: 2023-10-06 Number of Patients: 30 Recruitment Status: NOT_YET_RECRUITING Condition: Ovarian Cancer
NCTID: NCT04704219
Title: Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) Study Summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-02-23 Last Updated: 2023-08-29 Number of Patients: 152 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT05689619
Title: SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET) Study Summary: This study aims to evaluate the efficacy of silibinin in preventing recurrence in the brain after complete resection of a brain metastasis (BM) from non-small-cell lung cancer (NSCLC) or breast cancer (BC). Sponsor: Alessia Pellerino Intervention: Silibinin Start Date: 2023-01-02 Last Updated: 2023-01-19 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Brain Metastases, Adult
NCTID: NCT05645692
Title: A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2023-04-13 Last Updated: 2023-11-07 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Urothelial Cancer
NCTID: NCT04597125
Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. Sponsor: Bayer Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) Start Date: 2020-11-09 Last Updated: 2023-11-14 Number of Patients: 696 Recruitment Status: RECRUITING Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
NCTID: NCT05153330
Title: Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL Study Summary: A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL. Sponsor: Biomea Fusion Inc. Intervention: BMF-219 Start Date: 2022-01-24 Last Updated: 2023-10-06 Number of Patients: 177 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT04570631
Title: Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma Study Summary: Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment is in adult participants with relapsed/refractory (R/R) MM. Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. Participants in one arm will receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across the world. Participants will receive eftozanermin alfa as an infusion into the vein in combination with bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects. Sponsor: AbbVie Intervention: Eftozanermin alfa Start Date: 2020-11-05 Last Updated: 2023-07-13 Number of Patients: 40 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT04586231
Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Study Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-02-25 Last Updated: 2023-08-14 Number of Patients: 708 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT04008030
Title: A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator’s Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) Study Summary: The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants. Sponsor: Bristol-Myers Squibb Intervention: Ipilimumab Start Date: 2019-08-05 Last Updated: 2023-10-27 Number of Patients: 831 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT06132321
Title: Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233) Study Summary: This study aims to evaluate the patients’quality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Quality of life questionnaires Start Date: 2020-06-23 Last Updated: 2023-11-15 Number of Patients: 93 Recruitment Status: RECRUITING Condition: Vulvar Neoplasms
NCTID: NCT04209855
Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Study Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab Soravtansine Start Date: 2019-12-31 Last Updated: 2023-03-06 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Epithelial Ovarian Cancer
NCTID: 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: NCT03003325
Title: The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV Study Summary: The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years and without prior vascular events), in term of control of recommended level of hematocrit < 45%, over a period of 12 months. Sponsor: Fondazione per la Ricerca Ospedale Maggiore Intervention: AOP2014 Start Date: 2017-02-02 Last Updated: 2023-08-03 Number of Patients: 127 Recruitment Status: COMPLETED Condition: Polycythemia Vera
NCTID: NCT05186753
Title: (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis Study Summary: This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. Sponsor: Cogent Biosciences, Inc. Intervention: Bezuclastinib Tablets (Formulation A) Start Date: 2022-06-27 Last Updated: 2023-10-30 Number of Patients: 138 Recruitment Status: RECRUITING Condition: SSM
NCTID: NCT01997229
Title: Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study) Study Summary: The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis. Sponsor: Alexion Pharmaceuticals, Inc. Intervention: Eculizumab Start Date: 2013-12 Last Updated: 2019-07-16 Number of Patients: 125 Recruitment Status: COMPLETED Condition: Refractory Generalized Myasthenia Gravis
NCTID: NCT02668653
Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Chemotherapy Start Date: 2016-09-01 Last Updated: 2023-11-18 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT05796960
Title: European Multicenter Study on Surgical Management of Advanced Thyroid Cancer Study Summary: The main aim of the study is to evaluate peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in patients undergoing surgery for advanced thyroid cancer in different European centers using the EUROCRINE® database. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Thyroidectomy with or without lymphadenectomy or multivisceral resection Start Date: 2022-12-15 Last Updated: 2023-04-04 Number of Patients: 3917 Recruitment Status: RECRUITING Condition: Thyroid Carcinoma
NCTID: NCT05930860
Title: Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms Study Summary: Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of “en bloc” resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Endoscopic Submucosal Dissection Start Date: 2021-12-12 Last Updated: 2023-07-05 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT04551053
Title: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) Study Summary: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. Sponsor: Incyte Corporation Intervention: parsaclisib Start Date: 2021-05-26 Last Updated: 2023-10-18 Number of Patients: 177 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT03734029
Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Study Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants’ cancer: * Cannot be removed by an operation * Has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (DS-8201a) Start Date: 2018-12-27 Last Updated: 2023-06-15 Number of Patients: 557 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: 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: NCT03833661
Title: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) Study Summary: The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: M7824 Start Date: 2019-03-26 Last Updated: 2023-10-25 Number of Patients: 159 Recruitment Status: COMPLETED Condition: Biliary Tract Cancer
NCTID: NCT04725188
Title: Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002) Study Summary: The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab coformuation Start Date: 2021-04-20 Last Updated: 2023-07-06 Number of Patients: 255 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT05831553
Title: TIP in Patients Affected by Metastatic TNBC Study Summary: Triple-negative breast cancer (TNBC) is defined by the absence of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) expression on cancer cells. TNBCs accounts for 15-20% of all breast cancers (BC).1 It is characterized by a worse prognosis, increased risk of metastasis to vital organs and a relative lack of therapeutic target if compared to other BC subtypes.2 Therefore, the identification of new molecular targets and therapeutic strategies is a critical need in both early and metastatic setting. TNBC appears to be more immunogenic compared to other BC6. Immunotherapy has recently changed the landscape of therapeutic options in TNBC. Recent clinical trials have shown a significant clinical benefit in patients with metastatic TNBC treated with a combination of chemotherapy and anti PD-1 agents.11-12-13-14-15 In particular, results from IMPASSION 130 trial showed a significant benefit in both progression free survival (PFS) and overall survival (OS) in PD-L1 positive (PD-L1+) patients treated with a combination of atezolizumab and nab-paclitaxel.20 However, about 70% of PD-L1+ patients has experienced a disease progression after one year and about 50% was alive at 2 year. Moreover, no difference in survival endpoint has been seen in PD-L1 negative (PD-L1-) population, with an increase of toxicity and costs related to the addition of a checkpoint-inhibitor. Therefore, the identification of novel biomarkers in addition to PD-L1 and the combination of several biomarkers in a profile with higher predictive capacity is considered an area of urgent clinical need. Some immune-related features that can be identified in tumor microenvironment have been demonstrated to be independent prognostic and predictive factors: TILs, PD-L1, CD73. # Tumour-infiltrating lymphocytes (TILs) control the clinical progression of various types of cancer7. Breast cancer with higher levels of infiltrating CD8+ cytotoxic T cells have been associated with better patient survival8. Moreover, high levels of stromal CD8+ TILs (sTILs) correlate with higher probability of pCR9. Not only quantitative, but also qualitative analysis of TILs is a promising research area. Some studies suggest that different subtypes of TILs may have an opposite role in tumor microenvironment allowing the induction of both immune activating (es. CD8+) or immune suppressive (es FOXP3+) environment8-9-10. # The interaction between programmed cell death protein 1 (PD-1) and its ligand (PD-L1) represents one of the principal mechanisms of immune escape and a therapeutic target for several malignancies13-14. PD-1/PD-L1 interaction attenuates lymphocyte activation and promotes T-regulatory cell development and function, allowing to terminate the immune response15. In breast cancer the prognostic role of PD-1/PD-L1 axis is still uncertain with limited and contrasting data. PD-L1 positivity (≥1%) on immune cells (IC) is the clinical most used threshold, according to the results of IMPASSION 130 trial.18-24 # Recently, CD73 has been identified as a possible further molecular immunosuppressive target in triple negative breast cancer28. CD73 is expressed on the surface of tumoral cells, stromal cells and immunological cells. By increasing extracellular levels of adenosine monophosphate , CD73 suppresses immune responses. CD73 has been found to be overexpressed in several types of human cancers, and it has been associated with a poor prognosis29-30-31. Particularly Loi et al demonstrated that high CD73 expression is associated with poor prognosis in TNBC and to a low rate of pathological complete response32. We defined a tissue immune profile positive (TIP+) as the simultaneous presence of TILs≥50%, CD73≤40% and PD-L1≥1%. Any other combination was defined as TIP negative (TIP-) In conclusion, we will evaluate the association between TIP and clinical outcomes (ORR, PFS, OS). Sponsor: Fondazione per la Medicina Personalizzata Intervention: Tissue Immune Profile Start Date: 2022-09-16 Last Updated: 2023-05-06 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Metastatic Triple-negative Breast Cancer
NCTID: NCT04294810
Title: A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer Study Summary: The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-03-04 Last Updated: 2023-11-03 Number of Patients: 620 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT03438396
Title: A Trial of Tisotumab Vedotin in Cervical Cancer Study Summary: A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2018-06-12 Last Updated: 2023-07-25 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Cervical Cancer
NCTID: NCT04764188
Title: An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib Study Summary: This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2021-05-10 Last Updated: 2023-11-08 Number of Patients: 800 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: NSCLC
NCTID: NCT05011058
Title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas Study Summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas Sponsor: Viracta Therapeutics, Inc. Intervention: Nanatinostat in combination with valganciclovir Start Date: 2021-05-28 Last Updated: 2023-11-27 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Epstein-Barr Virus Associated Lymphoproliferative Disorder
NCTID: NCT03545035
Title: Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study Study Summary: The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: idelalisib and rituximab Start Date: 2019-02-06 Last Updated: 2022-05-12 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04515394
Title: Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE) Study Summary: The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Tepotinib Start Date: 2021-01-28 Last Updated: 2022-12-22 Number of Patients: 3 Recruitment Status: TERMINATED Condition: Colorectal Neoplasms
NCTID: NCT04733118
Title: Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer Study Summary: This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer. Sponsor: MedSIR Intervention: Trastuzumab and Pertuzumab (FDC SC) and T-DM1 Start Date: 2021-08-05 Last Updated: 2023-04-05 Number of Patients: 393 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT05138094
Title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection Study Summary: The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments. Sponsor: Fondazione Poliambulanza Istituto Ospedaliero Intervention: Minimally invasive simultaneous resection Start Date: 2021-08-06 Last Updated: 2022-07-25 Number of Patients: 82 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms Malignant
NCTID: NCT03804372
Title: The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide Study Summary: In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Rituximab Start Date: 2020-07-07 Last Updated: 2022-01-04 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Large-B-cell Diffuse Lymphoma
NCTID: NCT03250338
Title: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML Study Summary: This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation. Sponsor: Arog Pharmaceuticals, Inc. Intervention: Crenolanib Start Date: 2018-06-05 Last Updated: 2021-04-30 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
NCTID: NCT05763472
Title: Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation Study Summary: This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500). Start Date: 2022-03-01 Last Updated: 2023-03-10 Number of Patients: 10 Recruitment Status: RECRUITING Condition: BRCA-Associated Breast Carcinoma
NCTID: NCT05815472
Title: Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT) Study Summary: The use of advanced technological tools able to exploit patient-centered “Real World Data”, represents an innovative and fascinating challenge for the most modern personalized medicine paradigms. Monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction. The big data approach, being able to collect, manage and interpret large volumes of health data, eventually supported by artificial intelligence (A.I.) is therefore fundamental in this setting and may be translated in the next future in tangible advantages for the patients. Primary aim of the project is to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of a dedicated app and wearable technology (i.e. monitoring bracelet), as Electronic Health Record data harvesting devices. More specifically, the patients report experience measure of man/women affected by locally advanced non-small-cell lung cancer undergoing chemo(radio)therapy followed either by surgery or immunotehrapy (e.g. describing toxicity, instrumental activities of daily living and stress/coping levels) will be analyzed. The machine learning assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow up practices. This is an observational study with device, co-financed, monocentric study with a foreseen study duration of 36 months. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Fitbit charge Start Date: 2021-09-28 Last Updated: 2023-04-18 Number of Patients: 50 Recruitment Status: RECRUITING Condition: Non-small-cell Lung Cancer
NCTID: NCT06020625
Title: Mutational Oncology in Clinical Practice Study Summary: The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs. Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of “Personalized Medicine” and “Innovative Biotechnology.” In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Diagnostic Test Start Date: 2022-01-01 Last Updated: 2023-08-31 Number of Patients: 20000 Recruitment Status: RECRUITING Condition: Genome Instability
NCTID: NCT04712292
Title: Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer Study Summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Since then, the COVID-19 pandemic has caused a detrimental effect of the national health care system, causing a drastic reduction of the screening programs for colorectal cancer and requiring the redistribution of the hospital resources from elective surgery to the care of patients with SARS-Cov_2 infection requiring admission. Sponsor: University of Bologna Intervention: Surgical procedure for confirmed or suspected colorectal cancer Start Date: 2020-09-08 Last Updated: 2022-02-28 Number of Patients: 15000 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms Malignant
NCTID: NCT04404673
Title: Urinary and Sexual Dysfunctions Evaluation After Rectal Resection Study Summary: Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. Urinary and sexual functions can be significantly altered after rectal resection, mainly due to the iatrogenic lesions of the pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%, respectively. Despite the importance of this topic, most of the studies present in the literature are difficult to interpret for a variety of reasons. Firstly, both sexual and urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data, missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated instruments are the main limitation in drawing conclusive results. As additional factor, no clear evidence is present in the literature regarding the best approach to be used in order to preserve as much as possible both the sexual and urinary functionalities and to guarantee, at the same time, an adequate and oncologically correct rectal resection. Moreover, no data are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary and sexual functionalities. The main objective of the investigator’s prospective study will be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas. Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of the urinary and sexual functions by means of specific questionnaires. Secondary endpoints will be: * to investigate which technique (open, robotic, laparoscopic and trans-anal total mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions after radiochemotherapy (NAD+); * the comparison of both the urinary and sexual dysfunction incidence on the base of the distance of the rectal tumor from the anal verge and the evaluation of the best approach to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor height; * the short- (postoperative morbidity and histopathological data) and long-term (overall and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and robotic rectal resection. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Evaluation of urinary and sexual dysfunction after rectal resection Start Date: 2020-02-21 Last Updated: 2020-05-27 Number of Patients: 1172 Recruitment Status: RECRUITING Condition: Rectal Cancer
NCTID: NCT03917173
Title: Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study Study Summary: This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms. Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Surgery plus HIPEC CO2 Start Date: 2020-06-01 Last Updated: 2023-10-26 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Stomach Neoplasms
NCTID: NCT05601700
Title: Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) Study Summary: This is an Italian, multicenter, randomized, open-label phase III trial which will evaluate if Letrozole is superior to standard adjuvant chemotherapy in patients with hormone receptor positive low-grade serous epithelial carcinoma of the ovary (LGSCO). The hypothesis is that letrozole will significantly prolong median progression free survival (PFS) compared with the standard chemotherapy treatment, namely carboplatin AUC 5 and paclitaxel 175 mg/m2. Sponsor: Ente Ospedaliero Ospedali Galliera Intervention: Letrozole tablets Start Date: 2022-09-22 Last Updated: 2023-06-29 Number of Patients: 132 Recruitment Status: RECRUITING Condition: Carcinoma, Ovarian Epithelial
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: NCT04895358
Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2021-06-18 Last Updated: 2023-11-27 Number of Patients: 800 Recruitment Status: RECRUITING Condition: Breast 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: NCT04024436
Title: A Study of TAS-120 in Patients With Metastatic Breast Cancer Study Summary: The purpose of the trial is to evaluate a patient’s response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects. Sponsor: Taiho Oncology, Inc. Intervention: Futibatinib Start Date: 2019-08-30 Last Updated: 2023-08-21 Number of Patients: 168 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT05763524
Title: European Multicenter Study on Role of Lymph Node Dissection in Surgical Management of Adrenal Cortical Carcinoma Study Summary: This project will evaluate of the number of patients who underwent adrenalectomy for ACC in different European centers using the EUROCRINE® database. The analysis will focus on the extent of lymph nodal dissection (i.e. number of lymph nodes and nodal stations dissected during adrenalectomy). We aim to evaluate the oncologic radicality of surgical treatment and the rate of tumour recurrences after surgery and nodal metastasis related to the stage of the disease and to tumour side (left/right). Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Adrenalectomy with or without lymphadenectomy Start Date: 2022-12-15 Last Updated: 2023-03-20 Number of Patients: 90 Recruitment Status: RECRUITING Condition: Adrenocortical Carcinoma
NCTID: NCT02100696
Title: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors Study Summary: This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors. Sponsor: Hoffmann-La Roche Intervention: Etrozulimab Start Date: 2014-05-21 Last Updated: 2021-08-13 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Ulcerative Colitis
NCTID: NCT02394496
Title: Overcoming Endocrine Resistance in Metastatic Breast Cancer Study Summary: Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer. Sponsor: Consorzio Oncotech Intervention: Fulvestrant Start Date: 2007-11 Last Updated: 2016-06-15 Number of Patients: 396 Recruitment Status: UNKNOWN Condition: Metastatic Breast Cancer
NCTID: NCT01210495
Title: Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma Study Summary: The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma. Sponsor: Pfizer Intervention: Axitinib (AG-013736) Start Date: 2010-12-06 Last Updated: 2019-01-09 Number of Patients: 224 Recruitment Status: COMPLETED Condition: Hepatocellular Carcinoma
NCTID: NCT04468984
Title: Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis Study Summary: Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. 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 treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires. Sponsor: AbbVie Intervention: Navitoclax Start Date: 2020-08-31 Last Updated: 2023-11-14 Number of Patients: 330 Recruitment Status: RECRUITING Condition: Myelofibrosis (MF)
NCTID: NCT05020236
Title: MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Study Summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. Sponsor: Pfizer Intervention: Elranatamab Start Date: 2021-10-04 Last Updated: 2023-08-24 Number of Patients: 854 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT03306394
Title: A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). Study Summary: The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor’s prescription or can be accessed from another source or Sponsor decision. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/Tipiracil hydrochloride (S95005) Start Date: 2016-10-18 Last Updated: 2021-11-17 Number of Patients: 907 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT04173494
Title: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) Study Summary: MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF. Sponsor: Sierra Oncology LLC - a GSK company Intervention: Momelotinib Start Date: 2020-02-07 Last Updated: 2023-11-01 Number of Patients: 195 Recruitment Status: COMPLETED Condition: Primary Myelofibrosis
NCTID: NCT05099172
Title: First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) Study Summary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer. This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations. The main aims of this study are to find for BAY2927088 * how safe BAY2927088 is * how it affects the body (also referred to as tolerability) * how BAY2927088 moves into, through and out of the body * the maximum amount of BAY2927088 that the participants can take without too many side effects. The researchers will also study the action of BAY2927088 against the cancer. The study will have three parts: Dose Escalation, Backfill, and Dose Expansion. Each participant of the first, so called dose escalation part, will be assigned to one of specific sequential dose groups for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next. The second may be initiated at any dose that has already been tested during the first part and found to be safe and to have either reached a predicted efficacious exposure range or to have induced an objective response. The first part and second part will run concurrently. The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. The third part may be initiated in parallel with the first and second part based on emerging data. During the study, the participants will take the study treatment in 3 week periods called “cycles”. They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle. During the study, the study team will: * take blood and urine samples * take regular CT or MRI scans to check if the participants’ cancer has gotten better or worse * check the participants’ overall health and heart health * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. Sponsor: Bayer Intervention: BAY2927088_formulation A Start Date: 2021-10-25 Last Updated: 2023-11-28 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Advanced Non-small Cell Lung Cancer
NCTID: NCT05061823
Title: Bintrafusp Alfa Program Rollover Study Study Summary: This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data. Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study. The study also includes a 5 years survival follow-up after last dose of the study treatment. Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Bintrafusp alfa Start Date: 2021-12-01 Last Updated: 2023-11-07 Number of Patients: 32 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer
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: NCT05654623
Title: A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. Study Summary: A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer. Sponsor: Pfizer Intervention: ARV-471 Start Date: 2023-03-03 Last Updated: 2023-09-21 Number of Patients: 560 Recruitment Status: RECRUITING Condition: Advanced Breast Cancer
NCTID: NCT05239728
Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2022-03-15 Last Updated: 2023-11-28 Number of Patients: 1800 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT04168502
Title: Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML Study Summary: MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD. Role of a post-SCT maintenance with glasdegib. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Glasdegib Start Date: 2020-09-24 Last Updated: 2022-07-20 Number of Patients: 414 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT04246177
Title: Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable
on-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)
Study Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-05-22 Last Updated: 2023-09-13 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT06065358
Title: Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction Study Summary: Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window. For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients’ response to platinum. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Tumor biopsy Start Date: 2021-09-13 Last Updated: 2023-10-03 Number of Patients: 48 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT04679064
Title: Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician’s Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment Study Summary: Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician’s choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Niraparib Start Date: 2020-12-01 Last Updated: 2021-08-27 Number of Patients: 427 Recruitment Status: RECRUITING Condition: Ovarian 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: NCT04650984
Title: A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma Study Summary: The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in advanced or metastatic soft-tissue sarcoma patients. In the study, 102 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Sponsor: Philogen S.p.A. Intervention: Onfekafusp alfa Start Date: 2017-11-29 Last Updated: 2023-10-10 Number of Patients: 102 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
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: NCT04472598
Title: Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis Study Summary: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body’s normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires. Sponsor: AbbVie Intervention: Navitoclax Start Date: 2020-09-29 Last Updated: 2023-04-27 Number of Patients: 252 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis (MF)
NCTID: NCT04770896
Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab Study Summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-04-26 Last Updated: 2023-11-13 Number of Patients: 554 Recruitment Status: RECRUITING Condition: Unresectable Hepatocellular Carcinoma
NCTID: NCT04768296
Title: Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250) Study Summary: The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Berzosertib Start Date: 2021-03-29 Last Updated: 2023-08-15 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Small-cell Lung Cancer
NCTID: NCT04660344
Title: A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy Study Summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-05-03 Last Updated: 2023-10-10 Number of Patients: 520 Recruitment Status: RECRUITING Condition: Muscle-invasive Bladder Cancer
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: NCT05371223
Title: Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases Study Summary: Combined chemotherapy consisting of endovenous Nabpaclitaxel-Gemcitabine and Nabpaclitaxel-PIPAC may be a promising treatment for patients affected by pancreatic cancer PM who are in need of curative options. The purpose of this study is to evaluate the antitumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases. Secondary objectives include the evaluation of the feasibility, the safety, further assessment of the antitumoral activity, the overall and progression free survival, the QoL, the pharmacokinetics of Nabpaclitaxel PIPAC. Furthermore, the study aims to evaluate the patients’ nutritional status and the molecular evolution of PM along treatment with a time-course translational research. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Start Date: 2022-03-01 Last Updated: 2023-01-13 Number of Patients: 38 Recruitment Status: RECRUITING Condition: Peritoneal Carcinomatosis
NCTID: NCT04338269
Title: A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment Study Summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-07-28 Last Updated: 2023-10-27 Number of Patients: 522 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT06117774
Title: Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Study Summary: The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS). Sponsor: Amgen Intervention: Tarlatamab Start Date: 2024-01-27 Last Updated: 2023-11-07 Number of Patients: 400 Recruitment Status: NOT_YET_RECRUITING Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT03786081
Title: Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer Study Summary: This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part. Sponsor: Seagen Inc. Intervention: Tisotumab Vedotin Start Date: 2019-02-27 Last Updated: 2023-10-13 Number of Patients: 214 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cervical Cancer
NCTID: NCT04148911
Title: A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer Study Summary: Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-12-17 Last Updated: 2023-09-21 Number of Patients: 184 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple-Negative Breast Cancer
NCTID: NCT02631876
Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer Study Summary: This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator’s choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab soravtansine Start Date: 2016-03-02 Last Updated: 2020-10-14 Number of Patients: 366 Recruitment Status: COMPLETED Condition: Epithelial Ovarian Cancer
NCTID: NCT05634499
Title: A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer Study Summary: This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2023-06-27 Last Updated: 2023-11-07 Number of Patients: 45 Recruitment Status: RECRUITING Condition: Endometrial Cancer
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: NCT05789680
Title: European Multicentric Study on Parathyroid Carcinoma Study Summary: The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Surgical treatment of parathyroid carcinoma Start Date: 2022-12-15 Last Updated: 2023-03-29 Number of Patients: 17 Recruitment Status: RECRUITING Condition: Parathyroid Carcinoma
NCTID: NCT04303780
Title: Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation Sponsor: Amgen Intervention: AMG 510 Start Date: 2020-06-04 Last Updated: 2023-10-23 Number of Patients: 345 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
NCTID: NCT05052801
Title: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Study Summary: The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC) Sponsor: Amgen Intervention: Bemarituzumab Start Date: 2022-03-07 Last Updated: 2023-11-27 Number of Patients: 516 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT05023980
Title: A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-09-23 Last Updated: 2023-07-11 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01849874
Title: A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer Study Summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician’s choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study. Sponsor: Pfizer Intervention: MEK162, MEK inhibitor; oral Start Date: 2013-06-27 Last Updated: 2023-10-30 Number of Patients: 341 Recruitment Status: TERMINATED Condition: Low-grade Serous Ovarian Cancer
NCTID: NCT03884101
Title: Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) Study Summary: The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2019-04-11 Last Updated: 2023-11-02 Number of Patients: 842 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT05198934
Title: Sotorasib and Panitumumab Versus Investigator’s Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation Study Summary: The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator’s choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator’s choice (trifluridine and tipiracil, or regorafenib). Sponsor: Amgen Intervention: Sotorasib Start Date: 2022-04-19 Last Updated: 2023-09-21 Number of Patients: 160 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer (CRC)
NCTID: NCT05312398
Title: CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen Study Summary: This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX, irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate the activity and efficacy of cetuximab re-introduction in combination with irinotecan as third line therapy in the concept of re-challenge for those patients that will be treated in second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line treatment. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by liquid biopsy assessment of RAS/BRAF status. Sponsor: University of Campania “Luigi Vanvitelli” Intervention: Cetuximab Start Date: 2021-07-15 Last Updated: 2023-10-04 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Adenocarcinoma
NCTID: NCT04489940
Title: Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer Study Summary: The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Bintrafusp alfa Start Date: 2020-10-12 Last Updated: 2023-04-10 Number of Patients: 11 Recruitment Status: TERMINATED Condition: Triple Negative Breast Neoplasms
NCTID: NCT04623541
Title: Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome Study Summary: The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: * Monotherapy, or * Combination therapy: ** epcoritamab + venetoclax ** epcoritamab + lenalidomide ** epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter’s Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase. Sponsor: Genmab Intervention: Epcoritamab Start Date: 2020-11-25 Last Updated: 2023-11-15 Number of Patients: 184 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Chronic Lymphocytic Leukemia
NCTID: NCT04380636
Title: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-07-06 Last Updated: 2023-11-07 Number of Patients: 870 Recruitment Status: RECRUITING Condition: Lung Neoplasms
NCTID: NCT05296798
Title: A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) Study Summary: This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting. Sponsor: Hoffmann-La Roche Intervention: Phesgo Start Date: 2022-07-04 Last Updated: 2023-11-28 Number of Patients: 812 Recruitment Status: RECRUITING Condition: Locally Advanced or Metastatic Breast Cancer
NCTID: NCT04282811
Title: Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy Study Summary: Observational study aimed at describing the characteristics and outcome of CLL patients who started treatment with venetoclax-based regimens according to the local label outside clinical trials in Italy in a period of time ranging from the start of the Venetoclax Named Patient Program (March 2016) until October 31st, 2021. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Venetoclax Start Date: 2020-07-24 Last Updated: 2022-01-04 Number of Patients: 157 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04919811
Title: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC Study Summary: The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC. Sponsor: AnHeart Therapeutics Inc. Intervention: Taletrectinib Start Date: 2021-09-01 Last Updated: 2023-04-11 Number of Patients: 154 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT01968213
Title: Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) Study Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2014-04-07 Last Updated: 2023-06-09 Number of Patients: 564 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04191499
Title: A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. Sponsor: Hoffmann-La Roche Intervention: Inavolisib Start Date: 2020-01-29 Last Updated: 2023-11-18 Number of Patients: 325 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT05800613
Title: Management of Ovarian Masses in Pediatric Patients: an Italian Survey Study Summary: Objectives: The International Ovarian Tumor Analysis (IOTA) provides a specific terminology for adult ovarian masses, while, currently, there is no systematic classification for preoperative assessment of adnexal lesions in childhood and adolescence. This study aims to survey Italian pediatric surgeons to evaluate ovarian masses’ management (from diagnosis to treatment) in patients aged 1-18. Methods: A 27-question survey was distributed. It consisted of questions regarding the management and use of ultrasound and IOTA terminology in diagnosing ovarian masses in childhood and adolescence, in emergency regimes and in planned surgeries. Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Intervention: Survey Start Date: 2022-06-16 Last Updated: 2023-04-05 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Ovarian Cysts
NCTID: NCT05446870
Title: Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) Study Summary: The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2022-07-25 Last Updated: 2023-10-26 Number of Patients: 160 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: High-grade Serous Ovarian Carcinoma
