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NCT04149574 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
NCT04149574: Clinical Trial Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT04149574 is a Phase 3 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149574, a Phase 3 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC)
Interventions
- OTHER Placebo
- DRUG nivolumab
- BIOLOGICAL Bacillus Calmette-Guérin (BCG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2023-10-31 |
| Phase | Phase 3 |
Why NCT04149574 stopped before completion
NCT04149574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04149574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04149574 about?
NCT04149574 is a clinical study 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)". 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.
What is the current status of trial NCT04149574?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2020-01-15. Estimated completion is 2023-10-31.
What interventions are being tested in trial NCT04149574?
The interventions under investigation include: Placebo (OTHER), nivolumab (DRUG), Bacillus Calmette-Guérin (BCG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04149574?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04149574's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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