CHECKMATE-040-(NIVO-MONO-COHORT)

NCT01658878 📎

Regimen

Experimental
nivolumab (3 mg/kg Q2W in expansion)

Population

Advanced hepatocellular carcinoma with or without chronic viral hepatitis (HCV/HBV); sorafenib-untreated/intolerant or sorafenib-progressor; Child-Pugh A (expansion). Single-arm phase 1/2.

Key finding

ORR 20% in dose-expansion (3 mg/kg) including HCV/HBV/non-viral cohorts; durable responses; grade 3/4 TRAEs manageable; **supported FDA accelerated approval Sep 2017** for 2L post-sorafenib (later withdrawn Jul 2021 after CheckMate-459 OS negative and KN-240 did not meet significance)

Source: PMID 28434648

Timeline

    Guideline citations

    • NCCN HCC (p.18)