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Table 1 Clinical Trials in mCRC of immune-checkpoint inhibitors as single agents or in combination

From: Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated – NIVACOR trial (GOIRC-03-2018)

Drugs

Trial/Phase

Setting

Population

ORR n/N (%)

DCR n/N (%)

PFS

(mo = months)

OS

(mo = months)

Pembrolizumab [17]

NCT01876511

Phase II

> 2 L

MSI-H/dMMR

21/41

(52)

33/40 (82)

2-year = 59%

mPFS NR

2-year = 85%

mOS NR

Pembrolizumab [18, 19]

KEYNOTE-164

Phase II

> 2 L

MSI-H/dMMR

21/63

(33)

36/63

(57)

12-mo = 41%

mPFS 4.1 mo (2.1 – NR)

12-mo = 76%

mOS NR (19.2 – NR)

 

> 3 L

MSI-H/dMMR

17/61

(28)

31/61

(51)

12-mo = 34%

mPFS 2.3 mo (2.1–8.1)

12-mo = 72%

mOS NR

Pembrolizumab + mFOLFOX6 [20]

NCT02375672

Phase II

1 L

MSI-unselected

12/30

(40)

23/30

(77)

PFS not reported

mPFS 16.9 mo (7.4, 16.9)

OS not reported

mOS 8.8 mo (18.3-NE)

Nivolumab [21]

CheckMate 142

Phase II

> 2 L

MSI-H/dMMR

23/74

(31)

51/74

(69)

12-mo = 50%

mPFS 14.3 mo (4.3, NE)

12-mo = 73%

mOS, NR (18.0, NE)

Nivolumab + low dose Ipilimumab [22]

ChackMate 142

Phase II

> 2 L

MSI-H/dMMR

65/119 (55)

95/119 (80)

12-mo = 71%

mPFS NR

12-mo = 85%

mOS NR

Atezolizumab + bevacizumab and fluoropyrimidine [23]

NCT02291289

Phase II

1 L (maintenance)

MSI-unselected

Not reported

Not reported

mPFS 7.2 mo

mOS 22.1 mo

Atezolizumab + FOLFOX + bevacizumab [24]

NCT01633970 Phase Ib

> 2 L

Oxaliplatin naïve

9/25 (31)

Not reported

Not reported

Not reported

Atezolizumab + bevacizumab [25]

NCT01633970

Phase I

> 2 L

MSI-H/dMMR

4/10 (40)

9/10 (90)

mPFS NR (1.5–21.9)

mOS NR (2.6–23.7)

  1. *ORR Overall response rate, PFS Progression free survival, OS Overall survival, NE Not estimable, NR Not reached, m Median