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

  • Interventional
  • Recruiting
  • NCT03661320
Eligibility Details Visit Clinicaltrials.gov

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

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03661320

IRB#IRB18-1111

Lead SponsorBristol-Myers Squibb

Lead PhysicianRandy Sweis

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting