Editing Trials (University Cancer Center Frankfurt)

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'''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''': NCT04199104 
 '''Title''': A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010) 
 '''Study Summary''': This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.  Hypotheses include:  * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Lenvatinib 
 '''Start Date''': 2020-02-05 
 '''Last Updated''': 2023-11-02 
 '''Number of Patients''': 511 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Head and Neck Squamous Cell Carcinoma 
'''NCTID''': NCT03797326 
 '''Title''': Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) 
 '''Study Summary''': The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2019-02-12 
 '''Last Updated''': 2023-10-31 
 '''Number of Patients''': 590 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Advanced Solid Tumors 
'''NCTID''': NCT03713593 
 '''Title''': Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) 
 '''Study Summary''': The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.  The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': lenvatinib 
 '''Start Date''': 2018-12-31 
 '''Last Updated''': 2023-07-24 
 '''Number of Patients''': 794 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Carcinoma, Hepatocellular 
'''NCTID''': NCT03976362 
 '''Title''': A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008) 
 '''Study Summary''': The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study’s 2 primary hypotheses are:  # Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). # Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2019-06-28 
 '''Last Updated''': 2022-08-23 
 '''Number of Patients''': 857 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Carcinoma, Squamous Cell, Non-small-cell Lung 
'''NCTID''': NCT03260894 
 '''Title''': Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) 
 '''Study Summary''': The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC. 
 '''Sponsor''': Incyte Corporation 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2017-12-07 
 '''Last Updated''': 2023-10-26 
 '''Number of Patients''': 129 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Renal Cell Carcinoma (RCC) 
'''NCTID''': NCT03419572 
 '''Title''': Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma 
 '''Study Summary''': The objective of this study is to understand the utilization of cabozantinib in subjects with advanced renal cell carcinoma (RCC) following prior VEGF-targeted therapy in real life settings in terms of dose modifications due to adverse events (AEs) when used as a second line therapy or third and later line therapy. Other patterns of use of cabozantinib will also be described. 
 '''Sponsor''': Ipsen 
 '''Intervention''': Data collection 
 '''Start Date''': 2018-04-24 
 '''Last Updated''': 2022-08-15 
 '''Number of Patients''': 689 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Renal Cell Carcinoma 
'''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 &amp; 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''': NCT03797261 
 '''Title''': A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies 
 '''Study Summary''': This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin’s lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL).  This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD. 
 '''Sponsor''': AbbVie 
 '''Intervention''': Venetoclax 
 '''Start Date''': 2019-03-18 
 '''Last Updated''': 2021-12-07 
 '''Number of Patients''': 9 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Acute Myeloid Leukemia 
'''NCTID''': NCT01667419 
 '''Title''': A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma 
 '''Study Summary''': This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than <math display="block">\></math> 1 millimeter <math display="block">mm</math> in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Vemurafenib 
 '''Start Date''': 2012-09-24 
 '''Last Updated''': 2019-07-23 
 '''Number of Patients''': 498 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Melanoma 
'''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 &amp; 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''': NCT03765918 
 '''Title''': Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) 
 '''Study Summary''': This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 200 mg 
 '''Start Date''': 2018-12-17 
 '''Last Updated''': 2023-10-10 
 '''Number of Patients''': 704 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Head and Neck Neoplasms 
'''NCTID''': NCT03142334 
 '''Title''': Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) 
 '''Study Summary''': The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.  The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2017-06-09 
 '''Last Updated''': 2023-06-29 
 '''Number of Patients''': 994 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Renal Cell Carcinoma 
'''NCTID''': NCT02993523 
 '''Title''': A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy 
 '''Study Summary''': Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.  Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.  This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are &gt;= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.  In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.  Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body. 
 '''Sponsor''': AbbVie 
 '''Intervention''': Azacitidine 
 '''Start Date''': 2017-02-02 
 '''Last Updated''': 2023-07-03 
 '''Number of Patients''': 443 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Acute Myeloid Leukemia (AML) 
'''NCTID''': NCT03976323 
 '''Title''': Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006) 
 '''Study Summary''': The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study’s 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2019-06-28 
 '''Last Updated''': 2023-09-08 
 '''Number of Patients''': 1005 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Carcinoma, Non-squamous Non-small-cell Lung 
'''NCTID''': NCT05714202 
 '''Title''': A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer 
 '''Study Summary''': The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). 
 '''Sponsor''': Janssen Research &amp; Development, LLC 
 '''Intervention''': TAR-200 
 '''Start Date''': 2023-03-23 
 '''Last Updated''': 2023-11-08 
 '''Number of Patients''': 1050 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Bladder Cancer 
'''NCTID''': NCT03867084 
 '''Title''': Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937) 
 '''Study Summary''': This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2019-05-28 
 '''Last Updated''': 2023-09-08 
 '''Number of Patients''': 950 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Hepatocellular Carcinoma 
'''NCTID''': NCT04083976 
 '''Title''': A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations 
 '''Study Summary''': The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations. 
 '''Sponsor''': Janssen Research &amp; Development, LLC 
 '''Intervention''': Erdafitinib 
 '''Start Date''': 2019-11-20 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 316 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Advanced Solid Tumor