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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
nivolumab plus SoC (n=789) vs. Standard of Care (SoC) (n=792)
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 53.5 %, XELOX 46.5%
mGC or mGEJC - L1 - HER2 negative
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 (Opdivo) plus ipilimumab (Yervoy) and chemotherapy compared with chemotherapy alone asfrontline treatment of patients with metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma
pembrolizumab alone (n=92) vs. placebo plus SoC (n=90)
randomized controlled trial
pembrolizumab
pembrolizumab (200 mg every 3 weeks)
placebo plus chemotherapy (cisplatin plus fluorouracil or capecitabine)
cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks (no % for this sub-population)
3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo plus chemo
mGC or mGEJC - L1 - PDL1 positive
Patients had to have tumors that were ERBB2 negative with a PD-L1 CPS of 1 or greater for randomization
partially blind
200 sites in 29 countries
P3/ one sided and two interim analysis. The first 4 hypothesis were tested in parallel and then a hierarchical test procedure with reallocation with (P vs C) OS CPS>1 and CPS > 10, and (PC vs C) ORR CPS>1
Monotherapy demonstrated noninferiority to chemotherapy for OS, combination arm was not found to be superior for OS or PFS compared with chemotherapy alone
pembrolizumab alone (n=256) vs. Standard of Care (SoC) (n=250)
randomized controlled trial
pembrolizumab
pembrolizumab (200 mg every 3 weeks)
placebo plus chemotherapy (5FU or capecitabine plus cisplatin)
placebo plus cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks. 5FU (38.0%) and capacitabine (62.0%)
3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo plus chemo
mGC or mGEJC - L1 - PDL1 positive
Patients had to have tumors that were ERBB2 negative with a PD-L1 CPS of 1 or greater for randomization
partially blind
200 sites in 29 countries
P3/ one sided and two interim analysis. The first 4 hypothesis were tested in parallel and then a hierarchical test procedure with reallocation with (P vs C) OS CPS>1 and CPS > 10, and (PC vs C) ORR CPS>1
Monotherapy demonstrated noninferiority to chemotherapy for OS, and combination arm was not found to be superior for OS or PFS compared with chemotherapy alone
pembrolizumab plus SoC (n=257) vs. placebo plus SoC (n=250)
randomized controlled trial
pembrolizumab plus 5FU or capcitabine plus cisplatine
pembrolizumab (200 mg every 3 weeks) plus chemotherapy (cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks)
placebo plus 5FU or capcitabine plus cisplatine
pembrolizumab matched placebo plus chemotherapy : cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks. 5FU (38.0%) and capacitabine (62.0%)
all patients received chemotherapy => 3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo plus chemo
mGC or mGEJC - L1 - PDL1 positive
Patients had to have tumors that were ERBB2 negative with a PD-L1 CPS of 1 or greater for randomization
partially blind
200 sites in 29 countries
P3/ one sided and two interim analysis. The first 4 hypothesis were tested in parallel and then a hierarchical test procedure with reallocation with (P vs C) OS CPS>1 and CPS > 10, and (PC vs C) ORR CPS>1
Monotherapy demonstrated noninferiority to chemotherapy for OS, combination arm was not found to be superior for OS or PFS compared with chemotherapy alone
pembrolizumab plus SoC (n=99) vs. placebo plus SoC (n=90)
randomized controlled trial
pembrolizumab plus chemotherapy (5FU or capecitabine, plus cisplatine)
pembrolizumab (200 mg every 3 weeks)
placebo plus chemotherapy (5FU or capecitabine, plus cisplatine)
pembrolizumab matched placebo plus chemo (cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks) ( no % for this sub-population)
all patients received chemotherapy => 3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo
mGC or mGEJC - L1 - PDL1 positive
Patients had to have tumors that were ERBB2 negative with a PD-L1 CPS of 1 or greater for randomization
partially blind
200 sites in 29 countries
P3/ one sided and two interim analysis. The first 4 hypothesis were tested in parallel and then a hierarchical test procedure with reallocation with (P vs C) OS CPS>1 and CPS > 10, and (PC vs C) ORR CPS>1
Monotherapy demonstrated noninferiority to chemotherapy for OS combination arm was not found to be superior for OS or PFS compared with chemotherapy alone
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