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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 · View on ClinicalTrials.gov ↗
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2026-03-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04246177
The ClinicalTrials.gov registry entry for NCT04246177 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04246177 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Louisiana, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04246177?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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