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
Protocol # :
18-649
Conditions
Urinary Bladder Neoplasms
Muscle-invasive Bladder Cancer
Phase
III
Disease Sites
Urinary Bladder
Principal Investigator
McGregor, Bradley, A.
Site Investigator
Bubley, Glenn
Site Research Nurses
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

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

18-649