Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)
Public ClinicalTrials.gov record NCT03820986. 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 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Study identification
- NCT ID
- NCT03820986
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 674 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Lenvatinib Drug
- Placebo for lenvatinib Drug
Biological · Drug
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
- Mar 12, 2019 (Actual)
- Primary completion
- Jan 18, 2023 (Actual)
- Completion
- Nov 1, 2024 (Actual)
- Last update posted
- Feb 9, 2026
2019 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Angeles Clinic and Research Institute ( Site 0707) | Los Angeles | California | 90025 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704) | San Francisco | California | 30322 | — |
| California Pacific Medical Center Research Institute ( Site 0705) | San Francisco | California | 94115 | — |
| John Wayne Cancer Institute ( Site 0706) | Santa Monica | California | 90404 | — |
| University of Colorado Cancer Center ( Site 0708) | Aurora | Colorado | 80045 | — |
| Yale Cancer Center ( Site 0709) | New Haven | Connecticut | 06510 | — |
| Baptist MD Anderson Cancer Center ( Site 0767) | Jacksonville | Florida | 32207 | — |
| Mid-Florida Cancer Centers ( Site 0764) | Orange City | Florida | 32763 | — |
| AMG Oncology ( Site 0714) | Park Ridge | Illinois | 60068 | — |
| Illinois Cancer Care, PC ( Site 0765) | Peoria | Illinois | 61615 | — |
| Minnesota Oncology Specialist, PA ( Site 0766) | Fridley | Minnesota | 55432 | — |
| St. Vincent Frontier Cancer Center ( Site 0724) | Billings | Montana | 59102 | — |
| Atlantic Health System ( Site 0768) | Morristown | New Jersey | 07960 | — |
| Valley Hospital ( Site 0749) | Paramus | New Jersey | 07652 | — |
| University of North Carolina - Cancer Hospital ( Site 0751) | Chapel Hill | North Carolina | 27514 | — |
| OHSU Center for Health & Healing ( Site 0731) | Portland | Oregon | 97239 | — |
| Inova Schar Cancer Institute ( Site 0739) | Fairfax | Virginia | 22031-4867 | — |
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 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03820986, 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 9, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03820986 live on ClinicalTrials.gov.