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
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
- Age: minimum 18 Years maximum N/A
- Gender: All
- 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
- 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
View trial on ClinicalTrials.gov