drugset / Trial / 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)

NCT04149574 ↗

Phase 3 Terminated 13 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-01-15
Primary completion
2023-10-31
Completion
2023-10-31

Outcome

Outcome not reported

Stopped (Enrollment): “Insufficient enrollment, inability to meet protocol objectives, and slow accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody — —
Background Bacillus Calmette-Guerin (BCG) Vaccine — —