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. 2020 Aug 6;9(8):2533. doi: 10.3390/jcm9082533

Table 1.

Relevant Trials for FDA Approved Immunotherapy.

Line of Therapy Name of Drug Trial Name Trial Design Standard Arm Objective
Response Rate
Overall Survival Progression
Free Survival
PDL1 Status
Squamous Cell Esophageal Cancer
Second Pembrolizumab Keynote 181 open label randomized phase III chemotherapy (paclitaxel, docetaxel, irinotecan) 22% vs 7% (chemo) 10.3 months vs 6.7 months (chemo) 3.2 months vs 2.3 months (chemo) CPS >10
Second Pembrolizumab Keynote 180 open label single arm phase II none 14.3% (SCC) 5.8 months 2 months CPS >10
Second Nivolumab Attraction 3 open label randomized phase III chemotherapy (paclitaxel or docetaxel) 19.3% vs 21.5% (chemo) 10.5 months vs 8.4 months (chemo) 1.7 months vs 3.4 months (chemo) no
Gastroesophageal/Gastric Cancer
Third Pembrolizumab Keynote 059 open label single arm phase II none 11.6% 5.6 months 2 months CPS>1
Hepatocellular Cancer
Second Pembrolizumab Keynote 244 open label, non-randomized Phase II none 17% 12.9 months 4.9 months no
Second Nivolumab Checkmate
040
open label, non-comparative, dose escalation and expansion Phase I/II none 15% in dose escalation phase; 20% in dose expansion phase 83% at 6 months; 74% at 9 months 37% at 6 months; 28% at 9 months no
Second Nivolumab + Ipilimumab Checkmate040 open label, non-comparative, dose escalation and expansion Phase I/II none 33% 23 months 88% at 6 months; 31% at least 24 months no
First* Atezolizumab + Bevacizumab IMbrave 150 open label randomized Phase III sorafenib 28% vs 12% (sorafenib) Not est. vs 13.2 months (sorafenib) 6.8 months vs 4.5 (sorafenib) no
Colorectal Cancer
First for dMMR/MSI-H Pembrolizumab Keynote
177
Randomized Phase III chemotherapy (mFOLFOX6/
FOLFIRI +/- bevacizumab or cetuximab
43.8% vs 33.1% (chemo) Not achieved vs 10.6 months (chemo) 16.5 months vs 8.2 months (chemo) no
Second for dMMR/MSI-H Pembrolizumab Keynote
164
open label single arm Phase II none 33% 31.4 months 2.3 months no
Second for dMMR/MSI-H Nivolumab Checkmate 142 open label single arm Phase II none 31% 73% at 12 months 50.4% at 12 months no
Second for dMMR/MSI-H Nivolumab + Ipilimumab Checkmate 142 open label single arm Phase II none 46% 85% at 12 months 71% at 12 months no