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)
Description
Brief Summary
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).
Phase
N/AInclusion and Exclusion 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
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.