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Trial ID CA017-078  |   NCT03661320

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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).

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Key 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy

ASSIGNED INTERVENTION
  • Drug: Gemcitabine, Cisplatin

Study Arms

Experimental: Arm B: Nivolumab + GC Chemotherapy

ASSIGNED INTERVENTION
  • Biological: Nivolumab
  • Drug: Gemcitabine, Cisplatin

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