pembrolizumab alone (n=270) vs. Standard of Care (SoC) (n=272)
randomized controlled trial
pembrolizumab
pembrolizumab at dose of 200 mg every 3 weeks
chemotherapy (ICC) : paclitaxel, docetaxel, or vinflunine
investigator's choice of chemotherapy with paclitaxel (30.9%), docetaxel (30.9%), or vinflunine(32.0%) : paclitaxel (at a dose of 175 mg per square meter of body-surface area), docetaxel (at a dose of 75 mg per square meter), or vinflunine (at a dose of 320 mg per square meter), all administered intravenously every 3 weeks.
There was no planned crossover on disease progression.
mUC - L2 - all population
open-label
120 sites in 29 countries
P3 / one sided and two interim analysis. Repartition and hierachical testing procedure between coprimary endpoints
Pembrolizumab was associated with significantly longer overall survival (by approximately3 months) and with a lower rate of treatment-related adverse events than chemotherapyas second-line therapy for platinum-refractory advanced urothelial carcinoma.