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Table 1 Selected trials for monotherapy checkpoint inhibitor and VEGF TKI in unresectable gastroesophageal cancer

From: The integration of immune checkpoint inhibitors with VEGF targeted agents in advanced gastric and gastroesophageal adenocarcinoma: a review on the rationale and results of early phase trials

Trial Interventions Phases Treatment setting Results
NCT00548548 Bevacizumab + CTx versus CTx III 1st line ORR: 46 versus 37%
PFS: 6.7 versus 5.3 mo
OS: 12.1 versus 10.1 mo
Most common grade 3–4 AE: neutropenia (35%), anemia (10%), anorexia (8%)
REGARD
RAINBOW
Ramucirumab versus BSC
Ramucirumab + CTx versus CTx
III 2nd line OS:
Ramucirumab versus BSC: 5.2 versus 3.8 mo
Ramucirumab + CTx versus CTx: 9.6 versus 7.4 mo
Grade 3–4 AEs: 57% versus 58% (REGARD)
Grade 3–4 AEs: 47% versus 42% (RAINBOW)
INTEGRATE Regorafenib versus placebo II 2 or fewer lines of Tx PFS: 2.6 versus 0.9 mo
Grade 3–4 AE: 67% versus 52%
NCT00940225 Cabozantinib II Advanced, recurrent, or metastatic ORR: 10%
DCR: 33%
Grade 3–4 AE: 74.5%
KEYNOTE-59 Pembrolizumab II 3rd line
PD-L1 + 
ORR: 15.5%
mDOR: 16.3 mo
Grade 3–5 AE: 17.8%
KEYNOTE-62 Pembrolizumab or Pembrolizumab + CTx versus CTx III 1st line mOS: 10.6 versus 11.1 mo (CPS 1 or higher)
PFS: 6.9 versus 6.4 mo (CPS 1 or higher)
Grade 3–4 AE: 17% versus 73% versus 69% (Pembro versus Pembro + CTx versus CTx)
KEYNOTE-180 Pembrolizumab II 3rd line Overall ORR: 9.9%
mDOR: NR (1.9–14.4 mo)
Grade 3–4 AE: 12.4%
KEYNOTE-61 Pembrolizumab versus Paclitaxel III 2nd line mOS: 9.1 versus 8.3 mo
mPFS: 1.5 versus 4.1 mo
Grade 3–5 AE: 14% versus 35%
KEYNOTE-181 Pembrolizumab versus CTx III 2nd line mOS: 9.3 versus 6.7 mo (CPS 10 or higher)
Grade 3–5 AE: 18.2% versus 40.9%
KEYNOTE-590 Pembrolizumab + CTx versus CTx III 1st line mOS: 12.4 versus 9.8 mo
mDOR: 8.3 versus 6.0 mo
Discontinuation rates due to AEs: 19% versus 12%
CheckMate-649 Nivolumab + CTx versus CTx III 1st line mOS: 13.8 versus 11.6 mo (overall)
mOS: 14.0 versus 11.3 mo (CPS 1 or higher)
mOS: 14.4 versus 11.1 mo (CPS 5 or higher)
Grade 3–4 AEs: 59% versus 44%
CheckMate-32 Nivolumab w/wo ipilimumab I/II 2nd line ORR 12%, 24%
12-mo OS: 39%, 35%
Grade 3–4 AEs: 17% versus 47% versus 27%*
ATTRACTION-2 Nivolumab versus placebo III 2nd line mOS: 5.3 versus 4.1 mo
12-mo OS: 26.2 versus 10.9%
Grade 3–4 AEs: 10% versus 4%
JAVELIN Gastric 300 Avelumab versus CTx III 3rd line mOS: 4.6 versus 5.0 mo
PFS: 1.4 versus 2.7 mo
ORR: 2.2 versus 4.3%
Grade 3–4 AEs: 9.2% versus 31.6%
NCT02340975 Durvalumab w/wo ipilimumab I/II 2nd line ORR: 0%, 7.4%
12 mo OS: 4.6%, 37%
Grade 3–4 AEs: 17% versus 4%, versus 42% versus 16%**
  1. *Nivolumab only versus Nivolumab 1 mg/kg + ipilimumab 3 mg/kg versus nivolumab 3 mg/kg + ipilimumab 1 mg/kg
  2. **Durvalumab + tremelimumab in 2nd line setting versus durvalumab only versus trememlimumab only versus durvalumab + tremelimumab in 3rd line setting