A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC

• Status: Recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Gemcitabine; Linrodostat; Nivolumab

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