ClinicalTrials.gov recorded primary completion on 9 July 2026 for a Phase 3 study of nivolumab plus ipilimumab in participants with advanced hepatocellular carcinoma. The completed trial enrolled 732 participants who had not received prior systemic therapy and compared the combination with standard care using sorafenib or lenvatinib.

Background

The study evaluated nivolumab in combination with ipilimumab for participants with advanced hepatocellular carcinoma, a condition also known as advanced HCC in the registry record. The trial was designed for people whose disease had not previously been treated with systemic therapy. Registered interventions included nivolumab, ipilimumab, sorafenib, and lenvatinib.

Trial design

This was a Phase 3, completed clinical trial with 732 participants. Its stated purpose was to compare overall survival between nivolumab plus ipilimumab and standard of care in all randomized participants with advanced hepatocellular carcinoma who had not received prior systemic therapy. The standard-care arm consisted of sorafenib or lenvatinib.

The registry identified hepatocellular carcinoma as the study condition. The event reported here was primary completion, meaning the trial reached the completion milestone recorded by ClinicalTrials.gov on 9 July 2026. The supplied record does not list primary outcome measurements, key analyses, or an adverse-event summary.

What this means

The trial’s completion marks the end of the study period recorded in the supplied registry data for this comparison. However, the available record does not provide overall-survival results or other outcome measurements. It therefore does not establish whether nivolumab plus ipilimumab improved survival compared with sorafenib or lenvatinib, and it does not support a comparative safety conclusion or a new approval.

For clinicians, researchers, patient advocates, and editors reviewing the evidence, the key confirmed facts are the study’s Phase 3 design, completed status, enrollment of 732 participants, untreated advanced hepatocellular carcinoma population, and planned overall-survival comparison. Further interpretation requires a results record or publication containing the trial analyses.

Source

Source: ClinicalTrials.gov, clinical trial registry record for NCT04039607, with primary completion recorded on 9 July 2026. The record is available at clinicaltrials.gov/study/NCT04039607.