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NCT03661320 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
A Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 3
- Development phase
- 855
- Enrollment target
- 20
- Study locations
NCT03661320: Active Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer, sponsored by Bristol-Myers Squibb.
NCT03661320 is a Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 855 participants, above the 268-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (219% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03661320, a Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 855 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
Primary Outcome
Arm B vs. Arm A
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- BIOLOGICAL Nivolumab
Study Locations (20)
Massachusetts
- Local Institution - 0009 - Boston
- Local Institution - 0166 - Boston
- Local Institution - 0209 - Boston
New York
- Local Institution - 0029 - Albany
- Local Institution - 0069 - Lake Success
- Local Institution - 0047 - New York
Florida
- Local Institution - 0036 - Pensacola
- Local Institution - 0004 - Tampa
Illinois
- Local Institution - 0005 - Chicago
- Local Institution - 0006 - Peoria
Minnesota
- Local Institution - 0025 - Minneapolis
- Local Institution - 0129 - Minneapolis
Nebraska
- Local Institution - 0183 - Omaha
- Local Institution - 0001 - Omaha
Arizona
- Local Institution - 0022 - Tucson
California
- UC Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 855 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 3 |
What the registry record for NCT03661320 still lists
NCT03661320 is an interventional study that assigns participants to a tested intervention. The registered 855 participants enrollment target is mid-sized for trials with a published cap, above the 268-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (219% higher).
The record links to 2 conditions, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT03661320 names 20 study sites across 12 states, led by Massachusetts, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT03661320 about?
NCT03661320 is a clinical study titled "A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer". The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MI...
What is the current status of trial NCT03661320?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 855 participants. The study started on 2018-11-06. Estimated completion is 2027-12-30.
What conditions does trial NCT03661320 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms, Muscle-invasive Bladder Cancer.
What interventions are being tested in trial NCT03661320?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03661320?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03661320 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03661320's enrollment target sits among peer trials
855 2nd of 19 the highest of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder Neoplasms 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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