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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)

Trial Status: Active

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).

Inclusion Criteria

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology
  • Has HCC localized to the liver and not amenable to curative treatment
  • Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
  • Participants with Hepatitis B virus (HBV) are eligible as long as their virus is well controlled
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function

Exclusion Criteria

  • Is currently a candidate for liver transplantation
  • Has had gastric bleeding within the last 6 months
  • Has ascites that is not controlled with medication
  • Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
  • Has a serious nonhealing wound, ulcer, or bone fracture

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lia Etheridge
Phone: 310-825-7174
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Merck and Company Inc

  • Primary ID 7902-012
  • Secondary IDs NCI-2020-03946, MK-7902-012, LEAP-012, 2019-002345-37, E7080-G000-318, 205286
  • Clinicaltrials.gov ID NCT04246177