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: Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03661320
Sponsor: Bristol-Myers Squibb
Phase: Phase 3
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
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
View trial on ClinicalTrials.gov