Results from a Phase 1/Phase 2 trial evaluating the combination of nivolumab and ipilimumab for hepatocellular carcinoma prior to liver resection were posted on 2026-06-29. The study reported an objective response rate in 8 participants and a pathologic response rate in 9 participants among the enrolled patients.
Background
Nivolumab and ipilimumab are immunotherapeutic agents. This trial investigated their combination in patients with hepatocellular carcinoma who were scheduled for liver resection.
Trial design
This was a Phase 1/Phase 2 trial (NCT03682276) titled "Safety and Bioactivity of Ipilimumab and Nivolumab Combination Prior to Liver Resection in Hepatocellular Carcinoma". The study enrolled 33 participants with hepatocellular carcinoma for whom liver resection was planned. Participants received two doses of nivolumab and a single dose of ipilimumab in the weeks before their planned surgery.
Key results
The trial reported key measurements for the Treatment Group:
- Delay to Surgery was observed in 2 participants.
- The frequency of treatment-related adverse events was observed in 25 participants.
- The objective response rate was observed in 8 participants.
- The pathologic response rate was observed in 9 participants.
What this means
The results from this Phase 1/Phase 2 trial suggest that the combination of nivolumab and ipilimumab demonstrated bioactivity in patients with hepatocellular carcinoma prior to liver resection, with an objective response rate in 8 participants and a pathologic response rate in 9 participants. While 25 participants experienced treatment-related adverse events, these findings provide initial insights into the potential role of this immunotherapy combination in the neoadjuvant setting for HCC.
Source
The trial results were posted on 2026-06-29 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT03682276.