pembrolizumab plus ipilimumab (n=284) vs. pembrolizumab plus placebo (n=284)
randomized controlled trial
pembrolizumab plus ipilimumab
pembrolizumab at a dose of 200 mg on day 1 of each 3-week cycle for up to 35 cycles plus IV ipilimumab at a dose of 1 mg/kg on day 1 of each 6-week cycle for up to 18 cycles,
placebo plus pembrolizumab
saline placebo administered intravenously every 6 weeks for up to 18 doses pembrolizumab at a dose of 200 mg on day 1 of each 3-week cycle for up to 35 cycles in combination with placeb at the same dose and schedule.
mNSCLC - L1 - PDL1 positive
double blind
171 sites in 24 countries
P3/ one sided and OS and PFS interim analysis. Repartition between coprimay endpoint and reallocation with ORR, but the study stops for futility
The phase 3 KEYNOTE-598 study of pembrolizumab (Keytruda) plus ipilimumab (Yervoy) in a population of patients with metastatic non–small cell lung cancer (NSCLC) has been discontinued for futility