At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
In Brief
A Phase 3 clinical trial evaluating Lenvatinib, Pembrolizumab, and 3 other interventions for Carcinoma, Hepatocellular. Completed, enrolled 479 participants across 205 sites in 27 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
Study Details
Timeline
Interventions
Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) via oral capsules once a day during each 21-day cycle.
Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).
Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.
Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).
Conducted as a background procedure of chemotherapeutic and embolic agent(s).