Active — Not RecruitingPhase 3

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

United States855 participantsStarted 2018-11-06

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pathological Complete Response (pCR) rate, in all randomized participants

Timeframe: Approximately 43 months

Event-Free Survival (EFS), in all randomized participants

Timeframe: Approximately 36 months

Trial details

NCT IDNCT03661320

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-16

View on ClinicalTrials.gov More Urinary Bladder Neoplasms trials