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nivolumab plus SoC (n=473) vs. Standard of Care (SoC) (n=482)
randomized controlled trial
nivolumab plus chemotherapy
nivolumab (360 mg every3 weeks or 240 mg every 2 weeks) plus investigator’s choiceof chemotherapy (XELOX [capecitabine 1000 mg/m²twice a day, days 1–14 and oxaliplatin 130 mg/m², day 1,every 3 weeks] or FOLFOX [leucovorin 400 mg/m², day 1,fluorouracil 400 mg/m², day 1 and 1200 mg/m², days 1–2,and oxaliplatin 85 mg/m², day 1, every 2 weeks])
ICC (XELOX, FOLFOX)
investigator’s choiceof chemotherapy (XELOX [capecitabine 1000 mg/m²twice a day, days 1–14 and oxaliplatin 130 mg/m², day 1,every 3 weeks] or FOLFOX [leucovorin 400 mg/m², day 1,fluorouracil 400 mg/m², day 1 and 1200 mg/m², days 1–2,and oxaliplatin 85 mg/m², day 1, every 2 weeks])
mGC or mGEJC - L1 - HER2 neg/PDL1 positive
open label
175 hospitals, cancer centres in 29 countries across Asia, Australia, Europe, North/south America
P3/ two sided and one interim analysis (OS). For the dual primary endpoints, two-sided significancelevels (type I error) of 0·03 were allocated to OS and 0·02 to PFS. Hierarchically tested secondary endpoints were OS in patients with a PD-L1 CPS of one or more andall randomly assigned patients.
Overall survival (OS) and progression-free survival (PFS) were improved with nivolumab and chemotherapy compared with chemotherapy alone as frontline treatment of patients with metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma
nivolumab plus SoC (n=641) vs. Standard of Care (SoC) (n=655)
randomized controlled trial
nivolumab plus chemotherapy
nivolumab (360 mg every3 weeks or 240 mg every 2 weeks) plus investigator’s choiceof chemotherapy (XELOX [capecitabine 1000 mg/m²twice a day, days 1–14 and oxaliplatin 130 mg/m², day 1,every 3 weeks] or FOLFOX [leucovorin 400 mg/m², day 1,fluorouracil 400 mg/m², day 1 and 1200 mg/m², days 1–2,and oxaliplatin 85 mg/m², day 1, every 2 weeks])
ICC (XELOX, FOLFOX)
investigator’s choiceof chemotherapy (XELOX [capecitabine 1000 mg/m²twice a day, days 1–14 and oxaliplatin 130 mg/m², day 1,every 3 weeks] or FOLFOX [leucovorin 400 mg/m², day 1,fluorouracil 400 mg/m², day 1 and 1200 mg/m², days 1–2,and oxaliplatin 85 mg/m², day 1, every 2 weeks]) FOLFOX 51.5 %, XELOX 48.5%
mGC or mGEJC - L1 - HER2 neg/PDL1 positive
open label
175 hospitals, cancer centres in 29 countries across Asia, Australia, Europe, North/south America
P3/ two sided and one interim analysis (OS). For the dual primary endpoints, two-sided significancelevels (type I error) of 0·03 were allocated to OS and 0·02 to PFS. Hierarchically tested secondary endpoints were OS in patients with a PD-L1 CPS of one or more and all randomly assigned patients (splitting PE treshold).
Overall survival (OS) and progression-free survival (PFS) were improved with nivolumab and chemotherapy compared with chemotherapy alone as frontline treatment of patients with metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma
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