Primary Outcomes:

Primary Outcome 1 - Measure: Pathological Complete Response (pCR) rate, in all randomized participants

Primary Outcome 1 - Time Frame: Approx. 39 months

Primary Outcome 2 - Measure: Event-Free Survival (EFS), in all randomized participants

Primary Outcome 2 - Time Frame: Approx. 57 months

Condition:

• Bladder Cancer
• Muscle-Invasive Bladder Cancer
• BMS-986205

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No