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
Trial Description
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).
Eligibility Requirements
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