Trial results for the Phase 3 study (NCT04149574) investigating nivolumab in combination with Bacillus Calmette-Guerin (BCG) for participants with high-risk non-muscle invasive bladder cancer (HR NMIBC) were posted on ClinicalTrials.gov on 2025-09-16. The study, which was terminated early, enrolled 13 participants and reported adverse event data.
Background
The study investigated nivolumab in combination with Bacillus Calmette-Guerin (BCG) for the treatment of Urinary Bladder Neoplasms, specifically high-risk non-muscle invasive bladder cancer (HR NMIBC).
Trial design
The study (NCT04149574) was a Phase 3 trial that enrolled 13 participants with Urinary Bladder Neoplasms, specifically high-risk non-muscle invasive bladder cancer (HR NMIBC). The trial compared nivolumab in combination with Bacillus Calmette-Guerin (BCG) (Arm A) versus BCG alone (Arm B).
Key results
The trial was terminated early, and the results posted primarily detail adverse events. No efficacy outcomes were reported. Key safety measurements include:
- For "All-causality Adverse Events Leading to Discontinuation":
- In Arm A (Nivolumab + BCG), there was 1 participant, 0 participants, and 0 participants across reported measurements.
- In Arm B (BCG alone), there were 3 participants, 0 participants, and 0 participants across reported measurements.
- For "All-causality Adverse Events":
- In Arm A (Nivolumab + BCG), there was 1 participant, 4 participants, and 1 participant across reported measurements.
- In Arm B (BCG alone), there were 2 participants, 1 participant, and 1 participant across reported measurements.
What this means
The early termination of this Phase 3 trial and the limited enrollment of 13 participants mean that no definitive conclusions can be drawn regarding the efficacy of nivolumab in combination with BCG for high-risk non-muscle invasive bladder cancer. The reported adverse event data provides some safety insights from the small cohort, but these findings are not sufficient to establish a comprehensive safety profile or compare treatments due to the trial's termination and lack of efficacy data.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04149574, titled "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)," were posted on 2025-09-16 on clinicaltrials.gov.