Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma.

ABSTRACT:

Background

The role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery is not clear.

Methods

In a phase 3, multicenter, double-blind, randomized, controlled trial, we assigned patients with muscle-invasive urothelial carcinoma who had undergone radical surgery to receive, in a 1:1 ratio, either nivolumab (240 mg intravenously) or placebo every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed. The primary end points were disease-free survival among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more. Survival free from recurrence outside the urothelial tract was a secondary end point.

Resul

SUBMITTER: Bajorin DF 

PROVIDER: S-EPMC8215888 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature