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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Carcinoma, Hepatocellular
In brief
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).
Key facts
- Study ID
- NCT04246177
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 479
- Starts
- 2020-05-22
- Expected to finish
- 2026-03-26
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
You may not qualify if…
- 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
- Has received locoregional therapy to existing liver lesions
Where it is running
- Scripps Clinic Torrey Pines ( Site 0714) — La Jolla, California, United States
- USC Norris Comprehensive Cancer Center ( Site 0717) — Los Angeles, California, United States
- UCLA Hematology/Oncology - Santa Monica ( Site 0720) — Los Angeles, California, United States
- UC Irvine Health ( Site 0718) — Orange, California, United States
- Yale Cancer Center ( Site 0724) — New Haven, Connecticut, United States
- Tampa General Hospital ( Site 0764) — Tampa, Florida, United States
- Mountain States Tumor Institute ( Site 0773) — Boise, Idaho, United States
- University of Iowa Hospital and Clinics ( Site 0729) — Iowa City, Iowa, United States
- University of Kansas Cancer Center ( Site 0731) — Westwood, Kansas, United States
- University of Louisville ( Site 0757) — Louisville, Kentucky, United States
- Tulane Medical Center ( Site 0787) — New Orleans, Louisiana, United States
- University Medical Center New Orleans ( Site 0733) — New Orleans, Louisiana, United States
- Henry Ford Hospital-GI/Hepatology Research ( Site 0735) — Detroit, Michigan, United States
- Saint Louis University ( Site 0769) — St Louis, Missouri, United States
- University of New Mexico Comprehensive Cancer Center ( Site 0805) — Albuquerque, New Mexico, United States
- Monter Cancer Center ( Site 0780) — Lake Success, New York, United States
- Icahn School of Medicine at Mount Sinai ( Site 0744) — New York, New York, United States
- Wake Forest Baptist Health ( Site 0741) — Winston-Salem, North Carolina, United States
- University of Cincinnati Medical Center ( Site 0791) — Cincinnati, Ohio, United States
- The Ohio State University Wexner Medical Center ( Site 0759) — Columbus, Ohio, United States
- ProMedica Flower Hospital ( Site 0796) — Sylvania, Ohio, United States
- Stephenson Cancer Center ( Site 0745) — Oklahoma City, Oklahoma, United States
- OHSU Center for Health & Healing ( Site 0746) — Portland, Oregon, United States
- Penn State Hershey Medical Center ( Site 0766) — Hershey, Pennsylvania, United States
- Arizona Oncology Associates PC- HOPE ( Site 0770) — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.