Ipilimumab (10 mg/kg) (n=57) vs. Standard of Care (SoC) (n=57)
randomized controlled trial
ipilimumab
ipilimumab 10 mg/kg, every 3 weeks for four doses during the induction phase and then 10 mg/kg every 12 weeks for up to 3 years during the maintenance phase
SoC (maintenance)
either continuation of first-line fluoropyrimidine chemotherapy as maintenance or BSC maintenance treatment.
Crossover between treatment arms was not allowed.
mGC or mGEJC - L2 - all population
previous irradiation of the measurable lesion was not allowed.
open label
12 countries across Asia, Europe, and North America
P2/two sided and one interim analysis. Only irPFS (a=0.2) !! 20%
Although ipilimumab at 10 mg/kg was manageable, it did not improve irPFS versus BSC