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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 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.
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).
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 595-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (19% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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