avelumab alone (n=249) vs. Standard of Care (SoC) (n=250)
randomized controlled trial
avelumab maintenance
avelumab 10 mg/kg administered by intravenous infusionevery 2 weeks as maintenance phase
chemotherapy
continuation of the same chemotherapy regimen from the induction phase
All recruited patients received induction phase 1L therapy with oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX/FLO) or oxaliplatin and capecitabine (XELOX/CAPOX) for 12 weeks
mGC or mGEJC - M - HER2 negative
who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy ECOG > 2
open label
at 200 sites in North America, South America, Asia–Pacific and Europe.
P3 / one sided and one interim analysis. Alpha split between co-primary endpoint (2% OS overall 0.5% PDL1) with recycling strategy and hierarchical testing procedure with PFS then OS if both OS were significant
this study did not meet its primary objective of demonstrating superior overall survival. Avelumab maintenance after chemotherapy for patients with gastric cancer (JAVELIN Gastric 100 study) does not improve overall survival