Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial
In this open-label phase 1/2 study evaluating three treatment regimens (all combination nivolumab plus ipilimumab; n=148), the objective response rate was >30% in all arms. Further controlled trials are required; this combination is also being tested in the first-line setting.
Source:
JAMA Oncology
SPS commentary:
The highest response rate was observed in Arm A (32%; 95% CI 20%-47%), which consisted of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, administered every 3 weeks (4 doses), then nivolumab 240 mg every 2 weeks. This regimen received accelerated approval in the US based on the results of this study. This combination treatment is not yet approved for this indication in the UK/Europe.