Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: A randomized, open-label, phase 2 trial
The Lancet: Gastroenterology & Hepatology — Kaseb AO, Hasanov E, Cao HST, et al. | February 11, 2022
In advanced hepatocellular carcinoma, immunotherapy has been linked with improved survival. Researchers conducted this single-center, randomized, open-label, phase 2 trial, with the aim to examine the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma.
Researchers randomly assigned patients with resectable hepatocellular carcinoma (1:1) to receive 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery at 6 weeks) followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for 2 years, or 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery) plus one dose of 1 mg/kg of ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for up to 2 years plus 1 mg/kg of ipilimumab intravenously every 6 weeks for up to four cycles.
Overall, there was enrollment of 30 patients, 27 of whom were randomly assigned: 13 to nivolumab and 14 to nivolumab plus ipilimumab.
Nivolumab plus ipilimumab correlated with occurrence of higher grade 3–4 adverse events (six [43%] of 14 patients) compared with nivolumab alone (three [23%] of 13).
Surgery was not delayed in any of the patients in either group due to grade 3 or worse adverse events.
In patients with resectable hepatocellular carcinoma, it seems to be safe and feasible to administer perioperative nivolumab alone and nivolumab plus ipilimumab.
This work yields support for conducting further studies of immunotherapy in the perioperative setting in hepatocellular carcinoma.