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Hepatocellular cancer (HCC) is steadily increasing in the U.S. owing to hepatitis C virus infection and obesity-related nonalcoholic steatohepatitis. Treatment with first-line sorafenib and second-line regorafenib leads to a modest survival benefit, but antitumor response is limited, and survival remains poor.
Investigators now report results of an industry-sponsored, international, phase I/II dose-escalation and expansion trial (CheckMate 040) of the anti-PD-1 agent nivolumab in three cohorts of patients with advanced HCC: those with hepatitis C infection, hepatitis B infection, or no viral infection. The dose-escalation phase involved 48 patients who received 0.10 to 10 mg/kg of nivolumab every 2 weeks, and the dose-expansion phase involve…