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

Protocol # :
Urinary Bladder Neoplasms
Muscle-invasive Bladder Cancer
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.
Healy, Erin, C.
Kabarame, Liliane
Katica, Dean
Kelleher, Kaitlin
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