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)
Purpose
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).
Condition
- Carcinoma, Hepatocellular
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - 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 - Has received locoregional therapy to existing liver lesions
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Lenvatinib plus Pembrolizumab plus TACE |
Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years [~35 cycles] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s). |
|
Active Comparator Oral Placebo plus IV Placebo plus TACE |
Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s). |
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More Details
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC