Editing Trials (National Institute of Oncology)

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'''NCTID''': NCT05169567 
 '''Title''': Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer 
 '''Study Summary''': This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond. 
 '''Sponsor''': Eli Lilly and Company 
 '''Intervention''': Abemaciclib 
 '''Start Date''': 2022-03-11 
 '''Last Updated''': 2023-10-23 
 '''Number of Patients''': 350 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Neoplasm 
'''NCTID''': NCT02544633 
 '''Title''': Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET 
 '''Study Summary''': MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification <math display="block">increase number of gene copies</math>). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments. 
 '''Sponsor''': Mirati Therapeutics Inc. 
 '''Intervention''': MGCD265 
 '''Start Date''': 2015-10 
 '''Last Updated''': 2020-03-04 
 '''Number of Patients''': 68 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Non-Small Cell Lung Cancer 
'''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 &amp; 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''': NCT03427814 
 '''Title''': Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer 
 '''Study Summary''': This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer. 
 '''Sponsor''': BeiGene 
 '''Intervention''': Pamiparib 
 '''Start Date''': 2018-07-03 
 '''Last Updated''': 2023-09-21 
 '''Number of Patients''': 136 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Advanced or Inoperable Gastric Cancer 
'''NCTID''': NCT05059522 
 '''Title''': Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing 
 '''Study Summary''': This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies. 
 '''Sponsor''': Pfizer 
 '''Intervention''': Avelumab 
 '''Start Date''': 2021-09-29 
 '''Last Updated''': 2023-11-09 
 '''Number of Patients''': 262 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Advanced Malignancies 
'''NCTID''': NCT02947347 
 '''Title''': Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma 
 '''Study Summary''': The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma. 
 '''Sponsor''': Pharmacyclics LLC. 
 '''Intervention''': ibrutinib 
 '''Start Date''': 2017-01 
 '''Last Updated''': 2023-05-03 
 '''Number of Patients''': 445 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Follicular Lymphoma 
'''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''': NCT05947903 
 '''Title''': Validation of the European Oncology Quality of Life Toolkit 
 '''Study Summary''': The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.  A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.  The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.  This is a multicentre observational study, with the following aims:  * The primary aim is to perform the psychometric validation of the EUonQoL-Kit. * Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries.  The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).  Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:  * EORTC QLQ-C30, to test concurrent validity. * Live-CAT version, to test the feasibility of such implementation. * EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability. 
 '''Sponsor''': Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 
 '''Intervention''': Administration of the EUonQoL-Kit - Active Treatment questionnaire 
 '''Start Date''': 2024-04-01 
 '''Last Updated''': 2023-07-19 
 '''Number of Patients''': 4000 
 '''Recruitment Status''': NOT_YET_RECRUITING 
 '''Condition''': Cancer 
'''NCTID''': NCT02423603 
 '''Title''': PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer 
 '''Study Summary''': PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (&lt; 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v &gt; 12 months v no prior chemotherapy).  Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity.  Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent. 
 '''Sponsor''': Queen Mary University of London 
 '''Intervention''': Paclitaxel 
 '''Start Date''': 2014-05 
 '''Last Updated''': 2020-02-25 
 '''Number of Patients''': 140 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Metastatic Breast 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 &amp; 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''': NCT02178956 
 '''Title''': A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer 
 '''Study Summary''': The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy. 
 '''Sponsor''': Sumitomo Pharma America, Inc. 
 '''Intervention''': BBI608 
 '''Start Date''': 2014-10 
 '''Last Updated''': 2023-11-15 
 '''Number of Patients''': 714 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Gastric Cancer 
'''NCTID''': NCT02227251 
 '''Title''': Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) 
 '''Study Summary''': A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit. 
 '''Sponsor''': Karyopharm Therapeutics Inc 
 '''Intervention''': Selinexor 
 '''Start Date''': 2014-11 
 '''Last Updated''': 2023-08-07 
 '''Number of Patients''': 244 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Diffuse Large B-cell Lymphoma 
'''NCTID''': NCT05017012 
 '''Title''': A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of MK-3475A (Pembrolizumab Formulated With MK-5180) In Advanced Solid Tumors (MK-3475A-C18) 
 '''Study Summary''': This is a study to assess the pharmacokinetics, safety, and tolerability of pembrolizumab formulated with MK-5180 when administered as a SC injection to participants with advanced solid tumors. Participants will receive SC injections of MK-3475A containing one of 2 different concentrations (Conc) of pembrolizumab, Conc1 and Conc2, corresponding to a pembrolizumab dose level of dose 1 for Arms 1, 2, and 3 and dose 2 for Arm 4. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': MK-3475A 
 '''Start Date''': 2021-09-21 
 '''Last Updated''': 2023-11-18 
 '''Number of Patients''': 72 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Advanced or Metastatic Solid Tumors 
'''NCTID''': NCT01578655 
 '''Title''': Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer 
 '''Study Summary''': This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms. 
 '''Sponsor''': Achieve Life Sciences 
 '''Intervention''': cabazitaxel 
 '''Start Date''': 2012-08 
 '''Last Updated''': 2016-10-12 
 '''Number of Patients''': 630 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Prostate Cancer 
'''NCTID''': NCT02684006 
 '''Title''': A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) 
 '''Study Summary''': This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma 
 '''Sponsor''': Pfizer 
 '''Intervention''': Avelumab (MSB0010718C) 
 '''Start Date''': 2016-03-23 
 '''Last Updated''': 2023-11-09 
 '''Number of Patients''': 888 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Renal Cell Cancer 
'''NCTID''': NCT02715804 
 '''Title''': A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma 
 '''Study Summary''': The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). 
 '''Sponsor''': Halozyme Therapeutics 
 '''Intervention''': Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) 
 '''Start Date''': 2016-03-14 
 '''Last Updated''': 2020-07-14 
 '''Number of Patients''': 492 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Pancreatic Ductal Carcinoma 
'''NCTID''': NCT02627963 
 '''Title''': A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) 
 '''Study Summary''': This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).  Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.  Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor <math display="block">programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor</math> plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).  All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.  Pharmacokinetic (PK) analyses are also included in study. 
 '''Sponsor''': AVEO Pharmaceuticals, Inc. 
 '''Intervention''': Tivozanib hydrochloride 
 '''Start Date''': 2016-05-24 
 '''Last Updated''': 2023-07-18 
 '''Number of Patients''': 350 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Carcinoma, Renal Cell 
'''NCTID''': NCT03768063 
 '''Title''': A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study 
 '''Study Summary''': This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Atezolizumab 
 '''Start Date''': 2019-02-28 
 '''Last Updated''': 2023-11-09 
 '''Number of Patients''': 1000 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Cancer 
'''NCTID''': NCT04224493 
 '''Title''': Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma 
 '''Study Summary''': The participants of this study would have relapsed/refractory follicular lymphoma.  Follicular lymphoma is a type of blood cancer. It is referred to as ‘relapsed’ when the disease has come back after treatment and ‘refractory’ when treatment no longer works.  Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3.  Stage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. 
 '''Sponsor''': Epizyme, Inc. 
 '''Intervention''': Tazemetostat 
 '''Start Date''': 2019-12-19 
 '''Last Updated''': 2023-10-26 
 '''Number of Patients''': 540 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Relapsed/Refractory Follicular Lymphoma 
'''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 &amp; 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''': NCT01740427 
 '''Title''': A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) 
 '''Study Summary''': The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease. 
 '''Sponsor''': Pfizer 
 '''Intervention''': PD-0332991 
 '''Start Date''': 2013-02-22 
 '''Last Updated''': 2022-12-08 
 '''Number of Patients''': 666 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Neoplasms 
'''NCTID''': NCT02650193 
 '''Title''': A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body. 
 '''Study Summary''': This is a study of how one or more injections of HSP-130 under the skin effect the white blood cell counts and drug levels in women with breast cancer that has not spread to distant sites in the body (non-metastatic). This will be studied in women before breast surgery or while receiving chemotherapy. Safety will also be studied.  Additionally, the purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials. 
 '''Sponsor''': Pfizer 
 '''Intervention''': HSP-130 
 '''Start Date''': 2015-12 
 '''Last Updated''': 2018-10-23 
 '''Number of Patients''': 25 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Non-metastatic Breast Cancer 
'''NCTID''': NCT03390504 
 '''Title''': A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations 
 '''Study Summary''': The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-<math display="block">L</math>1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). 
 '''Sponsor''': Janssen Research &amp; Development, LLC 
 '''Intervention''': Erdafitinib 
 '''Start Date''': 2018-03-23 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 629 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Urothelial Cancer 
'''NCTID''': 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 &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2020-12-16 
 '''Last Updated''': 2023-11-24 
 '''Number of Patients''': 400 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Carcinoma, Renal Cell 
'''NCTID''': NCT01480479 
 '''Title''': Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma 
 '''Study Summary''': This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.  All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.  Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival. 
 '''Sponsor''': Celldex Therapeutics 
 '''Intervention''': Rindopepimut (CDX-110) with GM-CSF 
 '''Start Date''': 2011-11 
 '''Last Updated''': 2018-01-16 
 '''Number of Patients''': 745 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Glioblastoma 
'''NCTID''': 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''': NCT00523159 
 '''Title''': IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease 
 '''Study Summary''': This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.  Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination. 
 '''Sponsor''': Immatics Biotechnologies GmbH 
 '''Intervention''': Endoxana, IMA901, Leukine 
 '''Start Date''': 2007-05 
 '''Last Updated''': 2012-07-10 
 '''Number of Patients''': 68 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Renal Cell Carcinoma 
'''NCTID''': NCT03395197 
 '''Title''': Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC 
 '''Study Summary''': This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. 
 '''Sponsor''': Pfizer 
 '''Intervention''': Talazoparib with enzalutamide 
 '''Start Date''': 2017-12-18 
 '''Last Updated''': 2023-08-02 
 '''Number of Patients''': 1125 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': mCRPC 
'''NCTID''': NCT05514054 
 '''Title''': A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer 
 '''Study Summary''': The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. 
 '''Sponsor''': Eli Lilly and Company 
 '''Intervention''': Imlunestrant 
 '''Start Date''': 2022-10-04 
 '''Last Updated''': 2023-10-24 
 '''Number of Patients''': 6000 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Breast Neoplasms 
'''NCTID''': NCT05568095 
 '''Title''': A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body 
 '''Study Summary''': This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. 
 '''Sponsor''': Arcus Biosciences, Inc. 
 '''Intervention''': Domvanalimab 
 '''Start Date''': 2022-11-21 
 '''Last Updated''': 2023-11-15 
 '''Number of Patients''': 970 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Advanced Upper Gastrointestinal Tract Adenocarcinoma 
'''NCTID''': 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 &amp; 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''': NCT02513394 
 '''Title''': PALbociclib CoLlaborative Adjuvant Study 
 '''Study Summary''': This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).  The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. 
 '''Sponsor''': Alliance Foundation Trials, LLC. 
 '''Intervention''': Palbociclib 
 '''Start Date''': 2015-08 
 '''Last Updated''': 2023-06-15 
 '''Number of Patients''': 5796 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT04699461 
 '''Title''': Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma 
 '''Study Summary''': This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma. 
 '''Sponsor''': ADC Therapeutics S.A. 
 '''Intervention''': Loncastuximab Tesirine 
 '''Start Date''': 2021-11-04 
 '''Last Updated''': 2023-10-23 
 '''Number of Patients''': 6 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Relapsed Follicular Lymphoma 
'''NCTID''': NCT03654729 
 '''Title''': Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M) 
 '''Study Summary''': This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin. 
 '''Sponsor''': Egetis Therapeutics 
 '''Intervention''': Calmangafodipir (2 µmol/kg) 
 '''Start Date''': 2018-11-07 
 '''Last Updated''': 2021-12-17 
 '''Number of Patients''': 291 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Colorectal Cancer 
'''NCTID''': NCT03126435 
 '''Title''': EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX 
 '''Study Summary''': The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure. 
 '''Sponsor''': SynCore Biotechnology Co., Ltd. 
 '''Intervention''': EndoTAG-1 
 '''Start Date''': 2018-10-16 
 '''Last Updated''': 2023-05-06 
 '''Number of Patients''': 218 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Metastatic Pancreas Cancer 
'''NCTID''': NCT03778931 
 '''Title''': Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer 
 '''Study Summary''': This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) . 
 '''Sponsor''': Stemline Therapeutics, Inc. 
 '''Intervention''': Elacestrant 
 '''Start Date''': 2019-05-10 
 '''Last Updated''': 2022-07-22 
 '''Number of Patients''': 466 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT04524689 
 '''Title''': Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC (CARMEN-LC05) 
 '''Study Summary''': Primary Objective:  * Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population * Expansion part (including participants treated at the recommended dose for expansion <math display="block">RDE</math> from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population  Secondary Objectives:  * To assess the safety and tolerability of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population * To assess the antitumor activity of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population * To assess the durability of the response to treatment with several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population * To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population * To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or a triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed) * To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed 
 '''Sponsor''': Sanofi 
 '''Intervention''': SAR408701 (Tusamitamab ravtansine) 
 '''Start Date''': 2020-10-26 
 '''Last Updated''': 2023-11-18 
 '''Number of Patients''': 215 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) 
'''NCTID''': NCT04887831 
 '''Title''': Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab 
 '''Study Summary''': This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer. 
 '''Sponsor''': G1 Therapeutics, Inc. 
 '''Intervention''': Trilaciclib 
 '''Start Date''': 2021-06-04 
 '''Last Updated''': 2023-09-13 
 '''Number of Patients''': 92 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Urothelial Carcinoma 
'''NCTID''': NCT05005442 
 '''Title''': A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) 
 '''Study Summary''': The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab/vibostolimab coformuation 
 '''Start Date''': 2021-09-28 
 '''Last Updated''': 2023-09-01 
 '''Number of Patients''': 180 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Hematological Malignancies 
'''NCTID''': NCT02383810 
 '''Title''': Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID) 
 '''Study Summary''': This is a randomized, stratified, double-blind, double-dummy, parallel group, placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI). Patients will receive, starting from the day of chemotherapy administration, a single daily dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days. Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles.  The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.) placebo and vs. each other dose in the prevention of CID in colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal antibody. 
 '''Sponsor''': Helsinn Healthcare SA 
 '''Intervention''': Elsiglutide 
 '''Start Date''': 2015-02 
 '''Last Updated''': 2016-05-02 
 '''Number of Patients''': 498 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Drug and/or Toxin-induced Diarrhea 
'''NCTID''': NCT02971319 
 '''Title''': Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma 
 '''Study Summary''': This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison. 
 '''Sponsor''': Proactina S.A. 
 '''Intervention''': Tc-99M-Tetrofosmin SPECT 
 '''Start Date''': 2016-09 
 '''Last Updated''': 2018-01-26 
 '''Number of Patients''': 32 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Glioma (Diagnosis) 
'''NCTID''': NCT05288166 
 '''Title''': A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) 
 '''Study Summary''': The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months. 
 '''Sponsor''': Eli Lilly and Company 
 '''Intervention''': Abemaciclib 
 '''Start Date''': 2022-04-14 
 '''Last Updated''': 2023-10-19 
 '''Number of Patients''': 900 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Prostatic Neoplasms 
'''NCTID''': NCT04745832 
 '''Title''': Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) 
 '''Study Summary''': This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL. 
 '''Sponsor''': MEI Pharma, Inc. 
 '''Intervention''': Zandelisib 
 '''Start Date''': 2021-08-13 
 '''Last Updated''': 2023-05-09 
 '''Number of Patients''': 82 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Follicular Lymphoma (FL) 
'''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 &amp; 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''': NCT01569295 
 '''Title''': Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela ) 
 '''Study Summary''': The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL) 
 '''Sponsor''': Gilead Sciences 
 '''Intervention''': Idelalisib 
 '''Start Date''': 2012-06-15 
 '''Last Updated''': 2020-03-10 
 '''Number of Patients''': 416 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Chronic Lymphocytic Leukemia 
'''NCTID''': NCT04083235 
 '''Title''': A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment 
 '''Study Summary''': The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer. 
 '''Sponsor''': Ipsen 
 '''Intervention''': Irinotecan Liposomal Injection 
 '''Start Date''': 2020-02-11 
 '''Last Updated''': 2023-10-26 
 '''Number of Patients''': 770 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Metastatic Adenocarcinoma of the Pancreas 
'''NCTID''': NCT03748134 
 '''Title''': Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 ) 
 '''Study Summary''': This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.  After the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma 
 '''Sponsor''': Innovent Biologics (Suzhou) Co. Ltd. 
 '''Intervention''': Sintilimab 
 '''Start Date''': 2018-12-24 
 '''Last Updated''': 2023-10-24 
 '''Number of Patients''': 746 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Esophageal Squamous Cell Carcinoma 
'''NCTID''': NCT03748641 
 '''Title''': A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer 
 '''Study Summary''': The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo. 
 '''Sponsor''': Janssen Research &amp; Development, LLC 
 '''Intervention''': Niraparib 
 '''Start Date''': 2019-01-25 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 765 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Castration-Resistant Prostatic 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''': NCT03326674 
 '''Title''': Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC 
 '''Study Summary''': CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled. 
 '''Sponsor''': Odonate Therapeutics, Inc. 
 '''Intervention''': Tesetaxel and Capecitabine 
 '''Start Date''': 2017-12-21 
 '''Last Updated''': 2021-07-30 
 '''Number of Patients''': 685 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': 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 &amp; 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''': NCT01732913 
 '''Title''': Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas 
 '''Study Summary''': The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).  An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). 
 '''Sponsor''': Gilead Sciences 
 '''Intervention''': Placebo 
 '''Start Date''': 2013-01-16 
 '''Last Updated''': 2018-11-16 
 '''Number of Patients''': 295 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Indolent Non-Hodgkin’s Lymphomas 
'''NCTID''': NCT03940196 
 '''Title''': Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3) 
 '''Study Summary''': The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. 
 '''Sponsor''': NovoCure Ltd. 
 '''Intervention''': NovoTTF-100L(O) 
 '''Start Date''': 2019-03-22 
 '''Last Updated''': 2022-04-20 
 '''Number of Patients''': 540 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Ovarian Cancer