CheckMate 274 — An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Participants With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

Phase 3 · 2021 · Urothelial Carcinoma, Bladder Cancer

Design

Double-blind randomized trial of adjuvant nivolumab vs. placebo after radical surgery.

Population

High-risk muscle-invasive urothelial carcinoma of the bladder or upper tract after radical resection.

Primary Endpoint

disease-free survival (DFS) in all patients and in the PD-L1 >=1% subgroup

Key Result

5-year minimum follow-up: median DFS 21.9 vs 11.0 mo (HR 0.74); PD-L1 ≥1% DFS 55.5 vs 8.4 mo (HR 0.58); median OS 75.0 vs 50.1 mo (HR 0.83).

Guideline Impact

NCCN recommended adjuvant option for high-risk muscle-invasive urothelial carcinoma