ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT03711032

Public ClinicalTrials.gov record NCT03711032. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

Study identification

NCT ID
NCT03711032
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
1,397 participants

Conditions and interventions

Interventions

  • BCG Biological
  • Pembrolizumab Biological

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 23, 2018
Primary completion
Jul 30, 2026
Completion
Nov 19, 2034
Last update posted
Apr 30, 2026

2018 – 2034

United States locations

U.S. sites
44
U.S. states
20
U.S. cities
42
Facility City State ZIP Site status
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083) Anchorage Alaska 99503
Mayo Clinic in Arizona - Phoenix ( Site 1094) Phoenix Arizona 85054
Del Sol Research Management, LLC ( Site 1096) Tucson Arizona 85715
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 1052) Los Angeles California 90095
University of California Irvine Medical Center ( Site 1061) Orange California 92868
Genesis Research LLC ( Site 1065) Torrance California 90505
Colorado Clinical Research ( Site 1100) Lakewood Colorado 80228
Urological Research Network ( Site 1106) Hialeah Florida 33016
Mayo Clinic in Florida-Urology ( Site 1097) Jacksonville Florida 32224
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056) Miami Florida 33136
Woodlands Medical Specialists, PA ( Site 8002) Pensacola Florida 32503
Emory School of Medicine ( Site 1076) Atlanta Georgia 30322
Advanced Urology ( Site 1092) Roswell Georgia 30076
Northwestern Memorial Hospital ( Site 1101) Chicago Illinois 60611
Wichita Urology Group ( Site 1086) Wichita Kansas 67226
Ochsner LSU Health Shreveport - Regional Urology ( Site 1099) Shreveport Louisiana 71106
Henry Ford Hospital ( Site 1062) Detroit Michigan 48202
Michigan Institute of Urology ( Site 1077) Troy Michigan 48084
Coastal Urology Associates ( Site 1055) Brick New Jersey 08724
Morristown Medical Center ( Site 1090) Morristown New Jersey 07960
Rutgers Cancer Institute of New Jersey ( Site 1059) New Brunswick New Jersey 08901
St. Peter's Hospital Cancer Care Center ( Site 1087) Albany New York 12208
R.J. Zuckerberg Cancer Center ( Site 1080) Lake Success New York 11042
Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112) New York New York 10010
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074) New York New York 10016
Associated Medical Professionals of NY ( Site 1078) Syracuse New York 13210
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091) Cincinnati Ohio 45212
University Hospitals Cleveland Medical Center ( Site 1066) Cleveland Ohio 44106
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 1067) Columbus Ohio 43210
OHSU Knight Cancer Institute ( Site 1075) Portland Oregon 97210
Oregon Urology Institute ( Site 1098) Springfield Oregon 97477
MidLantic Urology ( Site 1071) Bala-Cynwyd Pennsylvania 19004
Lancaster Urology ( Site 1079) Lancaster Pennsylvania 17604
University of Pennsylvania ( Site 1088) Philadelphia Pennsylvania 19104
Carolina Urologic Research Center ( Site 1085) Myrtle Beach South Carolina 29572
Urology Associates [Nashville, TN] ( Site 1072) Nashville Tennessee 37209
Urology Clinics of North Texas, PLLC ( Site 1064) Dallas Texas 75231
University Of Texas Southwestern Medical Center ( Site 1053) Dallas Texas 75390
Texas Oncology-Fort Worth Cancer Center ( Site 8003) Fort Worth Texas 76104
Houston Metro Urology ( Site 1111) Houston Texas 77027
Texas Oncology-Plano West ( Site 8001) Plano Texas 75093
Urology San Antonio Research ( Site 1108) San Antonio Texas 78229
University of Vermont Medical Center ( Site 1057) Burlington Vermont 05401
Urology of Virginia ( Site 1070) Virginia Beach Virginia 23462

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 165 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03711032, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03711032 live on ClinicalTrials.gov.

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