atezolizumab alone (n=406) vs. no additional treatment (n=403)
randomized controlled trial
atezolizumab
1200 mgintravenous atezolizumab fora total of 16 cycles or 1 year, Dose reductions ofatezolizumab were not permitted.
observation
Crossover was not permitted
MIBC - NA - all population
selction regardless of PDL1 status
opan-label
192 hospitals, academic centres, and community oncology practices across 24 countries or regions
P3/ two sided with two interim analysis (OS). If results from the disease-freesurvival analysis were significant at an α value of 0·05,the analysis of overall survival was to be performed at anα level of 0·05,
IMvigor010 study evaluating Tecentriq ® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC)
CheckMate 274 (all population), 2017 NCT02632409
nivolumab alone (n=353) vs. placebo (n=356)
randomized controlled trial
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.