ClinicalTrials.gov posted results on 3 September 2026 for a Phase 3 trial of pembrolizumab, also known as Keytruda, with lenvatinib and transarterial chemoembolization (TACE) in people with incurable, non-metastatic hepatocellular carcinoma. The study enrolled 480 participants and was listed as terminated. Median progression-free survival was 14.6 months with lenvatinib, pembrolizumab, and TACE versus 10.0 months with placebo and TACE, while median overall survival was 40.4 versus 40.8 months.

Background

The study evaluated pembrolizumab and lenvatinib in combination with TACE for participants with incurable, non-metastatic hepatocellular carcinoma. The comparator regimen used oral and intravenous placebos with TACE. The stated hypotheses were that the pembrolizumab–lenvatinib combination would be superior to placebo plus TACE for progression-free survival and overall survival.

Trial design

This was a Phase 3 study identified as NCT04246177, also called LEAP-012. It enrolled 480 participants with hepatocellular carcinoma and was listed as terminated in the posted record.

The interventions were lenvatinib, pembrolizumab, oral placebo, and intravenous placebo. Outcomes included progression-free survival assessed by blinded independent central review using RECIST 1.1 and modified RECIST, overall survival, objective response rate, disease control rate, and duration of response.

Key results

  • RECIST 1.1 progression-free survival was 14.6 months with lenvatinib plus pembrolizumab and TACE versus 10.0 months with placebo plus TACE. The reported hazard ratio was 0.66, with a 95% confidence interval of 0.51 to 0.84 and p=0.0002.
  • Overall survival was 40.4 months in the lenvatinib–pembrolizumab–TACE group and 40.8 months in the placebo–TACE group. The reported hazard ratio was 0.98, with a 95% confidence interval of 0.76 to 1.26 and p=0.4442.
  • By modified RECIST, median progression-free survival was 14.6 months versus 9.8 months. The reported hazard ratio was 0.63, with a 95% confidence interval of 0.49 to 0.81 and p=0.0001.
  • Objective response rates were 71.3% versus 49.4%, a reported difference of 21.5 percentage points with a 95% confidence interval of 12.7 to 30.0 and p=0.0001.
  • Disease control rates were 90.3% versus 81.9%. Median duration of response was 14.5 months versus 12.5 months.

What this means

The posted results showed longer progression-free survival and higher response and disease-control rates for lenvatinib plus pembrolizumab with TACE than for placebo plus TACE. The overall-survival measurement was similar between groups, and the supplied analysis did not show a statistically significant overall-survival difference.

These results describe the regimen and comparison recorded in NCT04246177. The data block did not include an adverse-event summary, so comparative safety findings cannot be assessed from the supplied record.

Source

Source: ClinicalTrials.gov, registry results for “Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma,” NCT04246177, posted 3 September 2026. The record is available at clinicaltrials.gov/study/NCT04246177.