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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
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

NCT03661320

CompletedPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Urinary Bladder Neoplasms, Muscle-Invasive Bladder Cancer

Interventions: Nivolumab, Gemcitabine, Cisplatin

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (172)
  • Tucson, Arizona, United States
  • Sacramento, California, United States
  • Littleton, Colorado, United States
  • Pensacola, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Peoria, Illinois, United States
  • Columbia, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Minneapolis, Minnesota, United States
  • Omaha, Nebraska, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Albany, New York, United States
  • Lake Success, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Tigard, Oregon, United States
  • Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Norfolk, Virginia, United States
  • Capital Federal, Buenos Aires, Argentina
  • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina
  • Garran, Australian Capital Territory, Australia
  • + 142 more on CT.gov