Trials (Cancer Institute Strasbourg Europe): Difference between revisions
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=== Trials: How to participate === | |||
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Latest revision as of 19:12, 14 December 2025
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Contact information: Click here to access.
NCTID: NCT04717414
Title: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions Study Summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept. Sponsor: Celgene Intervention: ACE-536 Start Date: 2021-02-25 Last Updated: 2023-11-14 Number of Patients: 309 Recruitment Status: RECRUITING Condition: Myeloproliferative Disorders
NCTID: NCT03763422
Title: Trial in Low Grade Glioma Patients: Wait or Treat Study Summary: The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Temozolomide Start Date: 2020-03-16 Last Updated: 2022-02-01 Number of Patients: 19 Recruitment Status: TERMINATED Condition: Low-grade Glioma
NCTID: NCT04821622
Title: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Study Summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. Sponsor: Pfizer Intervention: talazoparib plus enzalutamide Start Date: 2021-05-12 Last Updated: 2023-11-22 Number of Patients: 599 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: 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: NCT04197986
Title: Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Study Summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer. Sponsor: QED Therapeutics, Inc. Intervention: Infigratinib Start Date: 2020-03-11 Last Updated: 2023-02-02 Number of Patients: 39 Recruitment Status: TERMINATED Condition: Upper Tract Urothelial Carcinomas
NCTID: NCT04949256
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and 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 Start Date: 2021-07-28 Last Updated: 2023-11-24 Number of Patients: 862 Recruitment Status: RECRUITING Condition: Metastatic Esophageal Squamous Cell Carcinoma
NCTID: NCT04300556
Title: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types Study Summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer <math display="block">OC</math>, endometrial cancer <math display="block">EC</math>, non-small cell lung carcinoma <math display="block">NSCLC</math>, triple-negative breast cancer <math display="block">TNBC</math>), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A <math display="block">OC and EC participants</math> and Part B <math display="block">EC only</math>): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202). Sponsor: Eisai Inc. Intervention: Farletuzumab ecteribulin Start Date: 2020-08-06 Last Updated: 2023-11-01 Number of Patients: 142 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT05198804
Title: A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer Study Summary: This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib in subjects with platinum-resistant ovarian cancer. Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Intervention: ZN-c3 Start Date: 2022-01-27 Last Updated: 2023-06-18 Number of Patients: 138 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT05696626
Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Study Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. Sponsor: Sermonix Pharmaceuticals Inc. Intervention: Lasofoxifene in combination with abemaciclib Start Date: 2023-10-31 Last Updated: 2023-11-14 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-21 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT05551117
Title: A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer Study Summary: Study CP-MGC018-03 is a randomized, open-label, Phase 2 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior taxane-containing regimen, but no other chemotherapy agents. The study will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg every 4 weeks <math display="block">Q4W</math> and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor. An analysis of radiographic progression-free survival (rPFS) will occur after 100 participants have been on-study for at least 6 months. Sponsor: MacroGenics Intervention: vobramitamab duocarmazine 2.0 mg (Arm A) Start Date: 2023-06-13 Last Updated: 2023-11-13 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Castration-Resistant Prostatic Cancer
NCTID: 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: NCT04975308
Title: A Study of Imlunestrant, Investigator’s Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2021-10-04 Last Updated: 2023-10-19 Number of Patients: 860 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT04322539
Title: A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer Study Summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC. Sponsor: Hutchison Medipharma Limited Intervention: Fruquintinib Start Date: 2020-08-12 Last Updated: 2023-09-14 Number of Patients: 691 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT04626479
Title: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) Study Summary: Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-16 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT03906071
Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Study Summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. Sponsor: Mirati Therapeutics Inc. Intervention: Nivolumab Start Date: 2019-07-15 Last Updated: 2023-10-24 Number of Patients: 532 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT04195750
Title: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) Study Summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2020-02-27 Last Updated: 2022-08-01 Number of Patients: 736 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: 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: NCT03148795
Title: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone). Sponsor: Pfizer Intervention: Talazoparib Start Date: 2017-07-04 Last Updated: 2023-05-10 Number of Patients: 128 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04093362
Title: Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Study Summary: This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements Sponsor: Taiho Oncology, Inc. Intervention: TAS-120 Start Date: 2020-03-01 Last Updated: 2023-10-11 Number of Patients: 216 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Cholangiocarcinoma
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT05083169
Title: A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd). Sponsor: Janssen Research & Development, LLC Intervention: Daratumumab Start Date: 2021-10-14 Last Updated: 2023-11-09 Number of Patients: 587 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT05079230
Title: Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia Study Summary: The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy. Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2022-07-07 Last Updated: 2023-10-30 Number of Patients: 432 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT03215030
Title: A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma Study Summary: The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein. Sponsor: Takeda Intervention: Modakafusp alfa Start Date: 2017-10-04 Last Updated: 2023-11-27 Number of Patients: 336 Recruitment Status: 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: NCT05117242
Title: Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer Study Summary: The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care Sponsor: Genmab Intervention: Acasunlimab Start Date: 2021-10-27 Last Updated: 2023-11-18 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer Metastatic
NCTID: NCT04246489
Title: Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer Study Summary: The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Bintrafusp alfa Start Date: 2020-03-30 Last Updated: 2023-10-23 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Uterine Cervical Neoplasms
NCTID: NCT04188548
Title: A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer Study Summary: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer. Sponsor: Eli Lilly and Company Intervention: LY3484356 Start Date: 2019-12-10 Last Updated: 2023-04-13 Number of Patients: 500 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04622319
Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2020-12-04 Last Updated: 2023-11-07 Number of Patients: 1600 Recruitment Status: RECRUITING Condition: HER2-Positive Primary Breast Cancer
NCTID: NCT05519085
Title: A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Study Summary: The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Sponsor: Celgene Intervention: mezigdomide Start Date: 2022-09-20 Last Updated: 2023-11-13 Number of Patients: 810 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT03436485
Title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer Study Summary: The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer. Sponsor: Orion Corporation, Orion Pharma Intervention: ODM-208 Start Date: 2018-03-19 Last Updated: 2023-03-23 Number of Patients: 192 Recruitment Status: RECRUITING Condition: Prostate Cancer Metastatic
NCTID: NCT05253651
Title: A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer Study Summary: This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: tucatinib Start Date: 2022-10-24 Last Updated: 2023-11-21 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT05111626
Title: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer Study Summary: The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival. Sponsor: Amgen Intervention: Bemarituzumab Start Date: 2022-03-14 Last Updated: 2023-11-27 Number of Patients: 528 Recruitment Status: RECRUITING Condition: Gastric Cancer
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: NCT04626518
Title: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) Study Summary: Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-12-17 Last Updated: 2023-11-02 Number of Patients: 370 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT03742895
Title: Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) Study Summary: This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD). Sponsor: Merck Sharp & Dohme LLC Intervention: Olaparib Start Date: 2018-12-12 Last Updated: 2023-11-24 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Advanced Solid Neoplasms
NCTID: NCT04191096
Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Study Summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2020-02-12 Last Updated: 2023-11-18 Number of Patients: 1251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Hormone-Sensitive Prostate Cancer
NCTID: NCT02834884
Title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access Study Summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: RP-1828 IMMUcan Start Date: 2017-05-03 Last Updated: 2023-11-03 Number of Patients: 4975 Recruitment Status: RECRUITING Condition: All Tumor Types
NCTID: NCT05089734
Title: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Study Summary: The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy (SG) Start Date: 2021-11-17 Last Updated: 2023-06-29 Number of Patients: 580 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT02952586
Title: Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100) Study Summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-11-28 Last Updated: 2021-09-22 Number of Patients: 697 Recruitment Status: TERMINATED Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT04697628
Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer Study Summary: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2021-02-22 Last Updated: 2023-11-14 Number of Patients: 556 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT03898180
Title: Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Study Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo 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), and # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). With Amendment 3 (effective: September <math display="block">Sep</math>-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-06 Last Updated: 2023-10-31 Number of Patients: 487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT04640623
Title: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy Study Summary: The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4). Sponsor: Janssen Research & Development, LLC Intervention: TAR-200 Start Date: 2020-12-18 Last Updated: 2023-11-08 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Urinary Bladder Neoplasms
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: NCT04601857
Title: Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma Study Summary: The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens. Sponsor: Taiho Oncology, Inc. Intervention: futibatinib and pembrolizumab Start Date: 2021-01-21 Last Updated: 2023-10-10 Number of Patients: 46 Recruitment Status: RECRUITING Condition: Advanced and Metastatic Urothelial Cancer
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: NCT03250676
Title: Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer Study Summary: The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene <math display="block">ESR1</math> Y537S mutation). Sponsor: Eisai Inc. Intervention: H3B-6545 Start Date: 2017-08-17 Last Updated: 2023-03-23 Number of Patients: 206 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasms
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: NCT04104776
Title: A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Study Summary: First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2. Sponsor: Constellation Pharmaceuticals Intervention: CPI-0209 Start Date: 2019-09-18 Last Updated: 2023-11-02 Number of Patients: 286 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
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: NCT05287113
Title: Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Study Summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). Sponsor: Incyte Biosciences International Sàrl Intervention: Retifanlimab Start Date: 2022-11-14 Last Updated: 2023-11-09 Number of Patients: 162 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
