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NCT03711032 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of High-Risk Non-Muscle-Invasive Bladder Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,397
- Enrollment target
- 20
- Study locations
NCT03711032: Active Phase 3 study of High-Risk Non-Muscle-Invasive Bladder Cancer, sponsored by Merck Sharp & Dohme.
NCT03711032 is a Phase 3 study of High-Risk Non-Muscle-Invasive Bladder Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,397 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03711032, a Phase 3 study of High-Risk Non-Muscle-Invasive Bladder Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,397 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
CRR is defined as the percentage of participants with carcinoma in situ (CIS) achieving a complete response (CR).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL BCG
Study Locations (20)
Florida
- Urological Research Network ( Site 1106) - Hialeah
- Mayo Clinic in Florida-Urology ( Site 1097) - Jacksonville
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056) - Miami
- Woodlands Medical Specialists, PA ( Site 8002) - Pensacola
California
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro - Los Angeles
- University of California Irvine Medical Center ( Site 1061) - Orange
- Genesis Research LLC ( Site 1065) - Torrance
Arizona
- Mayo Clinic in Arizona - Phoenix ( Site 1094) - Phoenix
- Arizona Urology Specialists (AUS)-Professional Park ( Site 1096) - Tucson
Georgia
- Emory School of Medicine ( Site 1076) - Atlanta
- Advanced Urology ( Site 1092) - Roswell
Michigan
- Henry Ford Health System ( Site 1062) - Detroit
- Michigan Institute of Urology ( Site 1077) - Troy
New Jersey
- Coastal Urology Associates ( Site 1055) - Brick
- Morristown Medical Center ( Site 1090) - Morristown
Alaska
- Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083) - Anchorage
Colorado
- Colorado Clinical Research ( Site 1100) - Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,397 participants |
| Start Date | 2018-12-24 |
| Est. Completion | 2034-11-20 |
| Phase | Phase 3 |
What the registry record for NCT03711032 still lists
NCT03711032 is an interventional study that assigns participants to a tested intervention. Its 1,397 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher).
The record links to 1 condition, with High-Risk Non-Muscle-Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03711032 names 20 study sites across 11 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03711032 about?
NCT03711032 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT03711032?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,397 participants. The study started on 2018-12-24. Estimated completion is 2034-11-20.
What conditions does trial NCT03711032 study?
This clinical trial studies the following conditions: High-Risk Non-Muscle-Invasive Bladder Cancer.
What interventions are being tested in trial NCT03711032?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), BCG (BIOLOGICAL).
Who is sponsoring clinical trial NCT03711032?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03711032 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03711032's enrollment target sits among peer trials
1,397 175th of 2000 higher than 1,826 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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