nivolumab followed by ipilimumab (n=68) vs. ipilimumab followed by nivolumab (n=70)
randomized controlled trial
nivolumab followed by ipilimumab
nivolumab 3 mg/kg as a 60-min intravenous infusion every 2 weeks for up to six doses, followed by a planned switch to ipilimumab 3 mg/kg as a 90-min intravenous infusion every 3 weeks for up to four doses
ipilimumab followed by nivolumab
ipilimumab 3 mg/kg as a 90-min intravenous infusion every 3 weeks for up to four doses followed by a planned switch to nivolumab 3 mg/kg as a 60-min intravenous infusion every 2 weeks for up to six doses (reciprocal planned switch sequence)
time interval between drug sequences was 2 weeks for nivolumab followed by ipilimumab whereas it was 3 weeks for ipilimumab followed by nivolumab patient with clinical benefit were eligible to enter the continuation period and receive nivolumab 3 mg/kg every 2 weeks for up to 2 years
mML - L1 - all population
Patients with active brain metastases were excluded
open label
nine sites in the USA
P2/ No statistical hypothesis testing, sequentiel N=>I vs I=>N No statistical hypothesis testing was planned (PE = safety)
No statistical hypothesis testing was planned to assess differences between groups because the primary endpoint was safety