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.
Gundy, Kathryn, E.
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).
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic
- 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