Trial Identifiers
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Scientific Title
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)
Commercial Sponsor
Merck
Summary
Eligible participants will be randomised to receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered orally at a dose of 12 mg or 8 mg, once a day during each 21-day cycle until progressive disease or unacceptable toxicity occurs. Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).