A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Official Title
-----------------
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

Conditions
-----------------
Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer

Intervention / Treatment
-----------------
* Biological: Nivolumab
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Exclusion Criteria: Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy<br> | Drug: Gemcitabine<br>* Specified dose on specified days<br>* Other names: Chemotherapy;Drug: Cisplatin<br>* Specified dose on specified days<br>* Other names: Chemotherapy;|
| Experimental: Arm B: Nivolumab + GC Chemotherapy<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: Gemcitabine<br>* Specified dose on specified days<br>* Other names: Chemotherapy;Drug: Cisplatin<br>* Specified dose on specified days<br>* Other names: Chemotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological Complete Response (pCR) rate, in all randomized participants | Arm B vs. Arm A | Approximately 43 months | 
| Event-Free Survival (EFS), in all randomized participants | Arm B vs. Arm A | Approximately 51 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) in all randomized participants | Arm B vs. Arm A | Approximately 60 months | 
| Incidence of Adverse Events (AE) in participants who received at least one treatment dose |  | Approximately 60 months | 
| Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose |  | Approximately 60 months | 
| Incidence of deaths in participants who received at least one treatment dose |  | Approximately 60 months | 
| Incidence of laboratory abnormalities in participants who received at least one treatment dose |  | Approximately 60 months | 
| pCR rate, descriptively in all concurrently randomized participants | Arm C vs. Arm B and Arm A | Approximately 43 months | 
| EFS, descriptively in all concurrently randomized participants | Arm C vs. Arm B and Arm A | Approximately 51 months | 
| OS, descriptively in all concurrently randomized participants | Arm C vs. Arm B and Arm A | Approximately 60 months |