CheckMate 067 (N vs I ; all population), 2015 NCT01844505
nivolumab alone (n=316) vs. ipilimumab alone (n=315)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram every 2 weeks (plus ipilimumab-matched placebo)
ipilimumab
ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses (plus nivolumab-matched placebo)
mML - L1 - all population
Other eligibility criteria included known BRAF V600 mutation status
double-blind
137 cancer centres in 21 countries
P3/ two sided test procedure without interim analysis (but OS prolonged) (efficacy endpoints were based on the intent-to-treat population and formal co-primary endpoint analyses were conducted at two different prespecified time points (separately for progression-free survival and overall survival) per the study protocol, as described previously)3 arms // repartition : OS 0.02/ARM (N vs I, NI vs I), PFS 0.005/ARM (N vs I, NI vs I), and hierarchical testing procedure for ORR with PFS results (N vs I, NI vs I)
Nivolumab alone or combined with ipilimumab improved progression-free survival (no threshold), as compared with ipilimumab, among previously untreated patients with metastatic melanoma