nivolumab alone (n=272) vs. Standard of Care (SoC) (n=133)
randomized controlled trial
nivolumab
nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxic effects. We allowed treatment with nivolumab beyond progression for patients experiencing clinical benefit and tolerating the drug as established by the investigator.
chemotherapy (investigator’s choice)
dacarbazine 1000 mg/m² every 3 weeks or paclitaxel 175 mg/m² combined with carboplatin area under the curve 6 every 3 weeks). (dacarbazine,33.8%; paclitaxel,42.9%) Treatment was given open-label because of the choices available to the investigators in the ICC group
We did not allow dose reductions with nivolumab treatment (dose reductions for chemotherapy were per institutional standards of care); however, we allowed dose delays
mML - L2 - all population
patients with active brain metastases and individuals who had had previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies;were excluded
open-label
90 sites in 14 countries
P3/ two sided test procedure with one interim analysis. Repartition between coprimary endpoint, and hierarchy for secondary endpoints
Nivolumab demonstrated higher, more durable responses but no difference in survival compared with ICC.