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Closed (no longer recruiting)Last updated: 1 February 2024

This phase III study is evaluating the benefits of combining targeted therapies (Nivolumab and/or BMS-986205) with chemotherapy for treatment before surgery (radical cystectomy), followed by continued treatment with the targeted therapy post surgery for patients with Muscle-Invasive Bladder CancerA 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

Clinical summary

Summary

Patients eligible to participate in this trial will be randomly assigned to receive one of three treatment regimes. The treatment regimes are: chemotherapy alone, chemotherapy with Nivolumab and a BMS-986205 placebo, or chemotherapy with Nivolumab and BMS-986205. All treatment regimes will also include radical cystectomy surgery.

Conditions

This trial is treating patients with Muscle-Invasive Bladder Cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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