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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

Inclusion Criteria Icon img
:
  • 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.
    1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

      Exclusion Criteria

      Exclusion Criteria Icon
      :
      • Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
        1. 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
          Additional Information *

          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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