Trial Details 159 Total Sites

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)

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.

phase

Phase 3

status

Recruiting

enrollment

1200

score

61

start date

2019-07-28

last updated

2022-01-12

biomarkers

N/A

Los Angeles, California
facility
UCLA Hematology/Oncology - Santa Monica ( Site 0081)
1 facility
Recruiting
Chicago, Illinois
facility
Mount Sinai Hospital Medical Center ( Site 0042)
1 facility
Recruiting
Portland, Oregon
facility
Oregon Health Sciences University ( Site 0031)
1 facility
Recruiting
Las Vegas, Nevada
facility
Comprehensive Cancer Centers of Nevada ( Site 0092)
1 facility
Recruiting
Milwaukee, Wisconsin
facility
Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)
1 facility
Recruiting
Omaha, Nebraska
facility
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)
1 facility
Recruiting
New Orleans, Louisiana
facility
Tulane Cancer Center ( Site 0066)
1 facility
Recruiting
Cleveland, Ohio
facility
University Hospitals Cleveland Medical Center ( Site 0036)
1 facility
Recruiting
Tampa, Florida
facility
Moffitt Cancer Center ( Site 0080)
1 facility
Recruiting
Aurora, Colorado
facility
University of Colorado Cancer Center ( Site 0022)
1 facility
Recruiting
Cincinnati, Ohio
facility
Tri-State Urologic Services PSC, Inc. ( Site 0094)
1 facility
Recruiting
Worcester, Massachusetts
facility
University of Massachusetts Worcester ( Site 0053)
1 facility
Recruiting