Adjuvant Pembrolizumab versus Observation in Muscle-Invasive Urothelial Carcinoma.

ABSTRACT:

Background

Muscle-invasive urothelial carcinoma is an aggressive disease with high rates of relapse. Whether pembrolizumab as adjuvant therapy would be effective in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery is unknown.

Methods

In this phase 3 trial, we randomly assigned patients, in a 1:1 ratio, to receive pembrolizumab at a dose of 200 mg every 3 weeks for 1 year or to undergo observation. Randomization was stratified according to pathological stage, centrally tested programmed death ligand 1 (PD-L1) status, and previous neoadjuvant chemotherapy. The coprimary end points were disease-free survival and overall survival in the intention-to-treat population. We considered the trial to be successful if either disease-free survival or ove

SUBMITTER: Apolo AB 

PROVIDER: S-EPMC11698643 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature