Table 2

Main ongoing trials with immune checkpoint inhibitors in gastric, GEJ and esophageal cancers

TargetAgentPhaseSetting
(treatment line)
TreatmentMain objectivesBiomarkerNCT identifier
PD-1 (±other agents)PembrolizumabIbRefractory PD-L1 +solid tumorsPembrolizumabORR=30%PD-L1
≥1%
NCT02054806
(KEYNOTE-028)
IIISecond linePembrolizumab versus SOCmOS=8.2 vs 7.1 months.
In PD-L1-positive: mOS=9.3 vs 6.7 months
PD-L1
(CPS ≥10%)
NCT03933449
(KEYNOTE-181)
IIIFirst linePembrolizumab+chemotherapy versus placebo +chemotherapyOngoingPD-L1
(CPS ≥10%)
NCT03189719
(KEYNOTE-590)
IICohort 1: refractory
Cohort 2: first line
Cohort 3: first line PD-L1+
Cohort 1: pembrolizumab monotherapy
Cohort 2: pembrolizumab +chemotherapy
Cohort: Pembrolizumab monotherapy
OngoingPD-L1NCT02335411
(KEYNOTE-059)
IIISecond linePembrolizumab versus paclitaxelOngoingPD-L1 positiveNCT02370498
(KEYNOTE-061)
IIIFirst linePembrolizumab or pembrolizumab +chemotherapy or placebo plus chemotherapyOngoingPD-L1 positiveNCT02494583
(KEYNOTE-062)
IIINeoadjuvant/adjuvantPembrolizumab+chemotherapy versus placebo +chemotherapyOngoingNANCT03221426
(KEYNOTE-585)
IIIFirst line, HER2+Pembrolizumab+Trastuzumab + Chemotherapy versus Placebo+Trastuzumab + ChemotherapyOngoingNANCT03615326
(KEYNOTE-811)
NivolumabIIIRefractoryNivolumab versus placebomOS=5.26 vs 4.14 months
12 month OS=26.2% vs 10.9%
NANCT02267343
(ATTRACTION-2)
IIIRefractoryNivolumab versus chemotherapymedian OS=10.9 vs 8.4 monthsPD-L1NCT02569242
(ATTRACTION-3)
II/IIIFirst lineNivolumab +chemotherapy
(Nivolumab+SOX vs Nivolumab+CapeOX)
ORR=57.1% with nivolumab plus SOX vs 76.5% with nivolumab plus CapeOX.
mPFS=9.7 months vs 10.6 months
PD-L1NCT02746796
(ATTRACTION-4)
I/IIRefractoryNivolumab versus Nivolumab+IpilimumabORR=12% with Nivolumab; vs 24% with Nivo 1+Ipi 3; vs 8% with Nivo 3+Ipi 1NANCT01928394
(CHECKMATE 032)
IIIFirst lineNivolumab+Ipilimumab or Nivolumab+chemotherapy versus chemotherapyOngoingPD-L1NCT02872116
IIIAdjuvant, resected Esophageal and GEJ cancersNivolumab versus placeboOngoingNANCT02743494
(CHECKMATE 577)
IIIFirst lineOPD-L1
≥1%
NCT03143153
(CHECKMATE 648)
PD-L1 (±other agents)DurvalumabIILocalized unresectable Esophageal cancerDurvalumab+chemoradiotherapy followed by durvalumab maintenanceOngoingNANCT03777813
AvelumabIRefractoryAvelumabNANANCT01772004
IIIThird line, refractoryAvelumab versus chemotherapyORR=2.2% vs 4.3%; mOS=4.6 vs 5 monthsPD-L1NCT02625623
(JAVELIN 300)
IIIMaintenance, after first lineAvelumab versus chemotherapyOngoingNANCT02625610
(JAVELIN 100)
Gastric and GEJ
IINeoadjuvantAvelumab+chemotherapyOngoingNANCT03288350
  • CPS, Combined Positive Score; GEJ, gastroesophageal junction; mOS, median overall survival; mPFS, median progression-free survival; NA, not available; NCT, national clinical trial; ORR, objective response rate; PD-1, programmed cell death-1; PD-L1, programmed cell death ligand-1; SOC, standard of care; SOX, S-1 (tegafur, gimeracil, and oteracil potassium) plus oxaliplatin.