nivolumab plus ipilimumab (n=303) vs. pemetrexed plus platin (n=302)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab (3 mg/kg intravenous infusion once every 2 weeks) plus ipilimumab (1 mg/kg intravenous infusion once every 6 weeks).
cisplatin or carboplatin plus pemetrexed
intravenous infusion of cisplatin (75 mg/m²) or carboplatin (area under the concentrationtimecurve 5 mg/mL per min) plus pemetrexed (500 mg/m²) every 3 weeks for a maximum of six cycles.
both treatment groups were pretreated with folic acid (350–1000 μg orally daily) and vitamin B12(1000 μg intramuscularly) 1 week before administration.Dose reductions were permitted for chemotherapy, but not for nivolumab or ipilimumab; cross-over is not allowed in this study
malignant mesothelioma (mMS) - 1st line (L1)
open label
103 hospitals across 21 countries
P3/ two sided and one interim analysis for OS. No formal statistical testing or allocation of alpha values for progression-free survival, objective response rate, and disease control rate
AI1 stop : Nivolumab in combination with ipilimumab significantly improved overall survival (OS) in treatment-naïve patients with unresectable malignant pleural mesothelioma (MPM) who were treated in the phase 3 CheckMate 743 clinical trial.