Pembrolizumab (Keytruda) Phase 3 HCC Trial Completes Primary Study

The primary study phase for the Phase 3 trial (NCT04246177) investigating pembrolizumab (Keytruda) in combination with lenvatinib for participants with incurable, non-metastatic hepatocellular carcinoma (HCC) was completed on 2025-08-19. This trial evaluated the safety and efficacy of the combination with transarterial chemoembolization (TACE) compared to TACE plus placebos.

Background

The study, known as MK-7902-012/E7080-G000-318/LEAP-012, aimed to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE for participants diagnosed with incurable, non-metastatic hepatocellular carcinoma (HCC).

Trial design

The Phase 3 study (NCT04246177) was designed to assess the safety and efficacy of the combination therapy. It enrolled 479 participants with incurable/non-metastatic hepatocellular carcinoma. The interventions included lenvatinib and pembrolizumab in combination with transarterial chemoembolization (TACE), compared against TACE plus oral placebo and intravenous (IV) placebo. The primary hypotheses were that pembrolizumab plus lenvatinib in combination with TACE would be superior to placebo plus TACE regarding progression-free survival (PFS) and overall survival (OS).

What this means

The completion of the primary study phase signifies that data collection for the main endpoints of the trial has concluded. Researchers will now proceed with data analysis to determine whether the combination of pembrolizumab and lenvatinib with TACE demonstrates superiority over TACE with placebos in treating incurable, non-metastatic hepatocellular carcinoma, based on the predefined primary endpoints of progression-free survival and overall survival. The findings from this study are anticipated to provide important insights into potential new treatment strategies for this patient population.

Source

Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04246177, titled "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 (MK-7902-012/E7080-G000-318/LEAP-012)," was updated to reflect primary completion on 2025-08-19 on clinicaltrials.gov.