IRB #

STUDY00019185

Title

Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma (LEAP-002)

Principal Investigator

Adel Kardosh

Study Purpose

The purpose of this study is to compare any good and bad effects of using pembrolizumab along with the usual chemotherapy, lenvatinib, to using the usual chemotherapy plus placebo.

Medical Condition(s)

“Hepatocellular Carcinoma”, “Lenvatinib”, “Pembrolizumab”

Eligibility Criteria

- HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
- BCLC Stage C disease, or BCLC Stage B disease
- Life expectancy of >3 months.
-Cannot have received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
-Cannot have received any prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, or CD137).

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

You will be in the study up to approximately 2 years, and visit the study site or have a phone call, as instructed by the investigator and staff, until you withdraw from the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Merck

Recruitment End

10/01/2026

Compensation Provided

No


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