Skip to main content

Table 5 The key reported clinical trials of of PD-1/PD-L inhibitors in patients with colorectal cancer

From: PD-1/PD-L blockade in gastrointestinal cancers: lessons learned and the road toward precision immunotherapy

Tumor type Target Drug Phase and identification Sample size Clinical end point TRAEs Reference
CRC PD-1 Pembrolizumab + mFOLFOX6 Phase II
NCT02375672
30 ORR 53%; SD 47%; 8-week DCR 100%; median PFS: not reached Grades 3–4 36.7% (pembrolizumab + mFOLFOX6), 13.2% (pembrolizumab alone) ASCO 2017 [161]
CRC PD-1 Pembrolizumab Electronic medical record 19 ORR 52%; CR 5%; PR 47%; SD 16%; DCR 68%; median OS 16.1 months; 12-month OS rate 79%; median PFS not reached; 12-month PFS rate 54% Data not available ASCO 2017 [162]
CRC PD-1 Nivolumab + ipilimumab Phase II
NCT02060188
27 ORR 41%; SD 52%; DCR (≥12 weeks) 78%; medians for DOR, PFS and OS: not reached Grades 3–4 37% ASCO 2017 [163]
CRC PD-1 Nivolumab Phase II
NCT02060188
74 ORR 31% (INV), 27% (IRRC); DCR 69% (INV), 62% (IRRC); 12-month PFS rate 8.4% (INV), 45.6% (IRRC); median OS not reached; DOR not reached; 6-month OS rate 83.4%; 12-month OS rate 73.8% Grades 3–4 20% ASCO 2017 [69]
CRC PD-1 Pembrolizumab Phase II
NCT01876511
53 ORR 50% (dMMR), 0% (pMMR); DCR 89% (dMMR), 16% (pMMR); median PFS: not reached (dMMR); 2.4 months (pMMR); median OS: not reached (dMMR); 6 months (pMMR) Data not available ASCO 2016 [68]
CRC PD-L1 Atezolizumab + cobimetinib Phase I
NCT01988896
23 ORR 17% Grades 3–4 34.8% ASCO 2016 [70]
CRC PD-1 Nivolumab; Nivolumab + Ipilimumab Phase II
NCT02060188
82 ORR (MSI-H) 27% (nivolumab 3 mg/kg), 15% (nivolumab 3 mg/kg + ipilimumab 1 mg/kg); median PFS (MSI-H) 5.3 months (nivolumab 3 mg/kg), not reached (nivolumab 3 mg/kg + ipilimumab 1 mg/kg); median OS (MSI-H) 16.3 months (nivolumab 3 mg/kg), not reached (nivolumab 3 mg/kg + ipilimumab 1 mg/kg) Any grade (MSI-H): 79% (nivolumab 3 mg/kg), 85% (nivolumab 3 mg/kg + ipilimumab 1 mg/kg), including diarrhea and fatigue and diarrhea; Grades 3–4 (MSI-H) 21% (nivolumab 3 mg/kg), 31% (nivolumab 3 mg/kg + ipilimumab 1 mg/kg) ASCO 2016 [67]
CRC PD-1 Pembrolizumab + radiotherapy/ablation Phase II
NCT02437071
19 interim ORR 9% (pembrolizumab + radiotherapy), 0% (pembrolizumab + ablation) Any grade 73%, including fatigue, rash, and nausea ASCO 2016 [164]
CRC PD-1 Pembrolizumab Phase II
NCT01876511
41 ORR 40% (dMMR CRC), 0% (pMMR CRC), 71% (dMMR other cancers); DCR 90% (dMMR CRC), 11% (pMMR CRC), 71% (dMMR other cancers); median PFS: not reached (dMMR CRC); 2.2 months (pMMR CRC); OS: not reached (dMMR CRC); 5.0 months (pMMR CRC) Data not available ASCO 2015 [165]