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NCT04246177 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Carcinoma, Hepatocellular, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
480
Enrollment target
20
Study locations

NCT04246177: Active Phase 3 study of Carcinoma, Hepatocellular, sponsored by Merck Sharp & Dohme.

NCT04246177 is a Phase 3 study of Carcinoma, Hepatocellular that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 480 participants, below the 595-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04246177, a Phase 3 study of Carcinoma, Hepatocellular, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
480 participants
Enrollment target
20
Study locations

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).

Primary Outcome

PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute incre

Conditions Studied

Carcinoma, Hepatocellular

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Oral Placebo
  • DRUG Lenvatinib
  • DRUG IV Placebo
  • PROCEDURE TACE

Study Locations (20)

California

  • Scripps Clinic Torrey Pines ( Site 0714) - La Jolla
  • USC Norris Comprehensive Cancer Center ( Site 0717) - Los Angeles
  • UCLA Hematology/Oncology - Santa Monica ( Site 0720) - Los Angeles
  • UC Irvine Health ( Site 0718) - Orange

Louisiana

  • Tulane Medical Center ( Site 0787) - New Orleans
  • University Medical Center New Orleans ( Site 0733) - New Orleans

New York

  • Monter Cancer Center ( Site 0780) - Lake Success
  • Icahn School of Medicine at Mount Sinai ( Site 0744) - New York

Arizona

  • Arizona Oncology Associates PC- HOPE ( Site 0770) - Tucson

Connecticut

  • Yale Cancer Center ( Site 0724) - New Haven

Florida

  • Tampa General Hospital ( Site 0764) - Tampa

Idaho

  • Mountain States Tumor Institute ( Site 0773) - Boise

Iowa

  • University of Iowa Hospital and Clinics ( Site 0729) - Iowa City

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2020-05-22
Est. Completion 2026-03-25
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the registry record for NCT04246177 still lists

NCT04246177 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, below the 595-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (19% lower).

The record links to 1 condition, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT04246177 names 20 study sites across 15 states, led by California, Louisiana, New York.

Frequently Asked Questions

What is clinical trial NCT04246177 about?

NCT04246177 is a clinical study titled "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)". 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 p...

What is the current status of trial NCT04246177?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2020-05-22. Estimated completion is 2026-03-25.

What conditions does trial NCT04246177 study?

This clinical trial studies the following conditions: Carcinoma, Hepatocellular.

What interventions are being tested in trial NCT04246177?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Oral Placebo (DRUG), Lenvatinib (DRUG), IV Placebo (DRUG), TACE (PROCEDURE).

Who is sponsoring clinical trial NCT04246177?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04246177 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Hepatocellular

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04246177's enrollment target sits among peer trials

480 9th of 27 higher than 19 of 27 other Carcinoma, Hepatocellular trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Hepatocellular trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04246177, the US trial registry maintained by the National Library of Medicine. NCT04246177 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.