MedTrace Logo

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)

NCT04246177 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2026-05-14

No results posted yet for this study

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).

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Lenvatinib

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) via oral capsules once a day during each 21-day cycle.

BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).

DRUG

Oral Placebo

Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.

DRUG

IV Placebo

Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).

PROCEDURE

TACE

Conducted as a background procedure of chemotherapeutic and embolic agent(s).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2025-08-19
Completion
2026-03-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Chile
  • China
  • Colombia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246177 on ClinicalTrials.gov