IRB #

STUDY00020744

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)

Principal Investigator

Khashayar Farsad

Study Purpose

The purpose of the study is to learn how well pembrolizumab and lenvatinib plus TACE works against liver cancer. We are hoping to find out if this combination of drugs and treatment will keep your disease from getting worse.

Medical Condition(s)

Liver Cancer
Hepatocellular Carcinoma
Non-metastatic Hepatocellular Carcinoma
Hepatoceullar Cancer
Incurable Hepatocellular Carcinoma
HCC

Eligibility Criteria

Inclusion:
-Has a radiologic diagnosis of Hepatocellular Carcinoma (HCC)
-Has a predicted life expectancy of >3 months
-Has localized HCC

Exclusion:
-Is currently a candidate for liver transplantation.
-Has had esophageal or gastric variceal bleeding within the last 6 months

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

You may receive study drug with or without TACE for up to 24 months and then will be followed until your disease worsens or the study ends.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD)

Recruitment End

04/25/2025

Compensation Provided

No


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