Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)
Public ClinicalTrials.gov record NCT03713593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).
Study identification
- NCT ID
- NCT03713593
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 794 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 30, 2018
- Primary completion
- Jun 20, 2022
- Completion
- Sep 23, 2024
- Last update posted
- Feb 4, 2026
2018 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus ( Site 0621) | Tucson | Arizona | 85721 | — |
| City of Hope Comprehensive Cancer Center ( Site 0587) | Duarte | California | 91010 | — |
| Scripps Health ( Site 0644) | La Jolla | California | 92037 | — |
| Pacific Hematology Oncology Associates ( Site 0588) | San Francisco | California | 94115 | — |
| UCLA ( Site 0589) | Santa Monica | California | 90404 | — |
| Georgetown University ( Site 0594) | Washington D.C. | District of Columbia | 20007 | — |
| University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596) | Miami | Florida | 33136 | — |
| Advent Health ( Site 0595) | Orlando | Florida | 32804 | — |
| Tampa General Medical Group ( Site 0629) | Tampa | Florida | 33606 | — |
| Emory University Winship Cancer Institute ( Site 0639) | Atlanta | Georgia | 30322 | — |
| University of Kansas Cancer Center ( Site 0600) | Westwood | Kansas | 66205 | — |
| Massachusetts General Hospital ( Site 0603) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center ( Site 0716) | Boston | Massachusetts | 02215 | — |
| Icahn School of Medicine at Mount Sinai ( Site 0611) | New York | New York | 10029 | — |
| University of Rochester ( Site 0613) | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center - Cancer Center ( Site 0612) | Stony Brook | New York | 11794 | — |
| University of Oklahoma Health Science Center ( Site 0625) | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University ( Site 0645) | Portland | Oregon | 97239 | — |
| Eastern Regional Medical Center, Inc. ( Site 0626) | Philadelphia | Pennsylvania | 19124 | — |
| Central Texas Veterans Healthcare System ( Site 0617) | Temple | Texas | 76504 | — |
| Cancer Care Northwest ( Site 0636) | Spokane | Washington | 99218 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 151 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03713593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2026 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03713593 live on ClinicalTrials.gov.