NCT04149574

A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DRUG	nivolumab	Specified Dose on Specified Days
OTHER	Placebo	Specified Dose on Specified Days
BIOLOGICAL	Bacillus Calmette-Guérin (BCG)	Specified Dose on Specified Days

Timeline

• Start date: 2020-01-15
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2019-11-04
• Last updated: 2025-09-16
• Results posted: 2025-09-16

Locations

63 sites across 16 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, France, Germany, Greece, Israel, Italy, Netherlands, Russia, Spain, Sweden

Regulatory

• FDA-regulated drug study