Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment, inability to meet protocol objectives, and slow accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette-Guérin (BCG) | Biological | Bacillus Calmette-Guerin BCG | ALIAS |
| nivolumab | Drug | Nivolumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
- interventionNames
- Drug: nivolumab
- Biological: Bacillus Calmette-Guérin (BCG)
- type
- PLACEBO_COMPARATOR
- label
- Arm B: placebo +BCG
- interventionNames
- Other: Placebo
- Biological: Bacillus Calmette-Guérin (BCG)
Primary outcomes (1)
- measure
- Part 2: Event Free Survival
- timeFrame
- Approximately 44 Months and 1 Week
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive * Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC) * Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Exclusion Criteria: * Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC * UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment * UC and/or CIS in the prostatic urethra within 12 months of enrollment Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available