CHECKMATE-8HW

NCT04008030 📎

Regimen

Experimental
Nivolumab 3 mg/kg + ipilimumab 1 mg/kg Q3W × 4 cycles, then nivolumab 480 mg Q4W
Control
Investigator's choice chemotherapy (mFOLFOX6 or FOLFIRI ± bevacizumab or cetuximab); nivolumab monotherapy as third arm

Population

MSI-H/dMMR metastatic CRC, 1L (primary analysis), centrally confirmed; also includes any-line comparison.

Key finding

Nivo+ipi vs chemotherapy in 1L MSI-H/dMMR mCRC: 24-month PFS 72% (95% CI 64–79) vs 14% (6–25); restricted mean survival time 10.6 months longer (95% CI 8.4–12.9); grade ≥3 TRAEs 23% (nivo+ipi) vs 48% (chemo); at 31.5-month median follow-up, PFS significantly better (P<0.001).

Source: PMID 39602630

Timeline

    Guideline citations

    • NCCN Colon (p.144)