nivolumab
nivolumab (240 mg intravenously) every 2 weeks for up to 1 year
placebo
placebo every 2 weeks for up to 1 year
Dose delaysor discontinuations were allowed to managetoxic effects.
MIBC - NA - all population
Neoadjuvant cisplatin-based chemotherapybefore trial entry was allowed
double blind
156 sites in 29 countries in North and South America, Europe, Asia, and Australia
The alpha level(0.01784 for the intention-to-treat populationand 0.01282 for the group of patients with a PD-L1expression level of ≥1%) for disease-free survivalwas adjusted for the planned interim analysis.The secondary end point of overall survivalwas planned to be formally compared withthe use of a hierarchical procedure in eachpopulation and will be assessed with longerfollow-up,
In this trial involving patients with high-risk muscle-invasive urothelial carcinoma who had undergone radical surgery, disease-free survival was longer with adjuvant nivolumab than with placebo in the intention-to-treat population and among patients with a PD-L1 expression level of 1% or more.