NCT03661320

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, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 855 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Urinary Bladder Neoplasms
• Muscle-Invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified dose on specified days
DRUG	Gemcitabine	Specified dose on specified days
DRUG	Cisplatin	Specified dose on specified days

Timeline

• Start date: 2018-11-06
• Primary completion: 2026-02-16
• Completion: 2027-12-30
• First posted: 2018-09-07
• Last updated: 2026-04-15

Locations

172 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Finland, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study