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
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
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).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 861 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date: November 6, 2018
Estimated Primary Completion Date: January 14, 2024
Estimated Study Completion Date: January 15, 2025
Arm:
- Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
- Experimental: Arm B: Nivolumab + GC Chemotherapy
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 861 |
| Actual Study start date | 06 November 2018 |
| Estimated Study Completion Date | 15 January 2025 |