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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

Not Enrolling

Trial ID:NCT03661320

View complete trial on

Protocol #:18-649

877-DF-TRIAL (877-338-7425)

Condition(s):Muscle-Invasive Bladder Cancer, Urinary Bladder Neoplasms


Principal Investigator:McGregor, Bradley, A.

Site Investigator(s):Bubley, Glenn,

Site Research Nurse(s):Aspinwall, Sheridan,
Bretta, Katherine, v.
Carey, Margaret, M.
Creaton, Eileen,
Gundy, Kathryn, E.
Katica, Dean,
Lagerstedt, Elizabeth,
Leisner, Claire,
Mingrino, Sage,
Pace, Amanda,
Polinski, Karen,
Porter, Kathryn,
Prisby, Judith,
Theodore, Catherine,
Walsh, Meghara,

Trial Description:
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).

Eligibility Requirements:
- 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

Protocol #: 18-649

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