Trial Details 82 Total Sites

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

phase

Phase 3

status

Recruiting

enrollment

1405

score

60

start date

2018-12-24

last updated

2022-01-05

biomarkers

N/A

New York City, New York
facility
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)
1 facility
Recruiting
Los Angeles, California
facility
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
1 facility
Recruiting
Philadelphia, Pennsylvania
facility
University of Pennsylvania ( Site 1088)
1 facility
Recruiting
Phoenix, Arizona
facility
Mayo Clinic ( Site 1094)
1 facility
Recruiting
Dallas, Texas
facility
University Of Texas Southwestern Medical Center ( Site 1053)
facility
Urology Clinics of North Texas, PLLC ( Site 1064)
2 facilities
Recruiting
Columbus, Ohio
facility
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10
1 facility
Recruiting
Detroit, Michigan
facility
Henry Ford Health System ( Site 1062)
1 facility
Recruiting
Portland, Oregon
facility
OHSU Knight Cancer Institute ( Site 1075)
1 facility
Recruiting
Tucson, Arizona
facility
Arizona Institute of Urology (AIU) - Northwest ( Site 1096)
1 facility
Recruiting
Nashville, Tennessee
facility
Urology Associates [Nashville, TN] ( Site 1072)
1 facility
Recruiting
Atlanta, Georgia
facility
Emory School of Medicine ( Site 1076)
1 facility
Recruiting
Virginia Beach, Virginia
facility
Urology of Virginia ( Site 1070)
1 facility
Recruiting