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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
avelumab alone (n=185) vs. Standard of Care (SoC) (n=186)
randomized controlled trial
avelumab
avelumab 10 mg/kg by intravenous infusion every 2 weeks
physician's choice of chemotherapy (paclitaxel or irinotecan)
physician's choice of chemotherapy (paclitaxel 80 mg/m2 on days 1, 8, and 15 or irinotecan 150 mg/m2 on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. 120 (64.5%) patients received irinotecan, 54 (29.0%) paclitaxel, and 3 patients (1.6%) received BSC only.
Subjects receiving physician’s choice plus BSC will not be offered to cross over to avelumab plus BSC.
mGC or mGEJC - L2 - all population
Notably, 93 patients (25.1%) were enrolled in Asian countries.
open-label
147 sites in North America, South America, Asia, Australia, and Europe
P3 / one sided and one Interim analysis. Hierarchy OS then PFS then ORR
Treatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy at this primary analysis.
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
nivolumab alone (n=330) vs. placebo (n=163)
randomized controlled trial
nivolumab
nivolumab at 3 mg/kg every 2 weeks
placebo
placebo every 2 weeks
mGC or mGEJC - L2 - all population
double blind
49 clinical sites in japan, south korea, and taiwan,
p3 / one sided and one interim analysis. No plan found
results suggest an improvement of OS and PFS but no specific statistical plan was found to validate this results.
pembrolizumab alone (n=296) vs. paclitaxel (n=296)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously every 3 weeks
paclitaxel
paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of 4week cycles
Patients in the paclitaxel group were not permitted to cross over to receive pembrolizumab.
mGC or mGEJC - L2 - all population
open label
148 medical centres in 30 countries
P3/ one sided and one interim analysis. Repartition OS/PFS and hierachy PDL1 et pop tot
Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher.
pembrolizumab alone (n=196) vs. paclitaxel (n=199)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously every 3 weeks
paclitaxel
paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of 4week cycles
Patients in the paclitaxel group were not permitted to cross over to receive pembrolizumab.
mGC or mGEJC - L2 - PDL1 positive
open label
148 medical centres in 30 countries
P3/ one sided and one interim analysis. Repartition OS/PFS and hierachy PDL1 and pop tot
Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher.
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
avelumab alone (n=30) vs. Standard of Care (SoC) (n=24)
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 neg/PDL1 positive
who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy ECOG > 2, PD-L1–positive status was defined as PD-L1 protein expression in > 1% of tumor cells.
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
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