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)
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.
Study identification
- NCT ID
- NCT03711032
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,397 participants
Conditions and interventions
Conditions
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 24, 2018 (Actual)
- Primary completion
- Jul 31, 2026 (Estimated)
- Completion
- Nov 20, 2034 (Estimated)
- Last update posted
- May 1, 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 May 1, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03711032 live on ClinicalTrials.gov.