A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Jan 15, 2025
  • participants needed
    861
  • sponsor
    Bristol-Myers Squibb
Updated on 9 July 2022
radical cystectomy
cancer
gemcitabine
nivolumab
bladder cancer
invasive bladder cancer
transurethral resection
cisplatin/gemcitabine
bladder tumor

Summary

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Details
Condition Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer
Treatment cisplatin, Gemcitabine, Nivolumab, BMS-986205, BMS-986205 Placebo
Clinical Study IdentifierNCT03661320
SponsorBristol-Myers Squibb
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

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
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