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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urinary Bladder Neoplasms

Intervention / Treatment
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* Drug: nivolumab
* Other: Placebo
* Biological: Bacillus Calmette-Guérin (BCG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)<br> | Drug: nivolumab<br>* Specified Dose on Specified Days<br>Biological: Bacillus Calmette-Guérin (BCG)<br>* Specified Dose on Specified Days<br>|
| Placebo Comparator: Arm B: placebo +BCG<br> | Other: Placebo<br>* Specified Dose on Specified Days<br>Biological: Bacillus Calmette-Guérin (BCG)<br>* Specified Dose on Specified Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival (EFS) |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening- Free Survival (WFS) |  | approximately 3 years | 
| Overall Survival (OS) |  | approximately 3 years | 
| Complete Response Rate (CRR) |  | approximately 3 years | 
| Duration of Response (DOR) |  | approximately 3 years | 
| Number of participants with laboratory abnormalities |  | approximately 3 years | 
| Number of participants with laboratory changes from baseline |  | approximately 3 years | 
| Number of participants with Adverse Events (AEs) |  | approximately 3 years | 
| Number of Deaths |  | approximately 3 years |