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-

Condition: Bladder Cancer, Muscle-Invasive Bladder Cancer, BMS-986205

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03661320

Sponsor: Bristol-Myers Squibb

Phase: Phase 3

Eligibility:

Inclusion Criteria:

Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component.
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 LN (≥ 10 mm in short axis) or metastatic bladder cancer
Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted
Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min