Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
Public ClinicalTrials.gov record NCT04662710. 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
Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
Study identification
- NCT ID
- NCT04662710
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 895 participants
Conditions and interventions
Interventions
- Pembrolizumab Biological
- Lenvatinib Biological
- Oxaliplatin Drug
- Capecitabine Drug
- Leucovorin (or Levoleucovorin) Drug
- 5-FU 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
- Dec 30, 2020 (Actual)
- Primary completion
- Oct 29, 2024 (Actual)
- Completion
- Mar 30, 2026 (Actual)
- Last update posted
- Apr 28, 2026
2020 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Hematology/Oncology - Santa Monica ( Site 0003) | Los Angeles | California | 90404 | — |
| Georgetown University Medical Center ( Site 0009) | Washington D.C. | District of Columbia | 20007 | — |
| James Graham Brown Cancer Center ( Site 0017) | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University ( Site 0052) | Baltimore | Maryland | 21224 | — |
| Dana Farber Cancer Center ( Site 0019) | Boston | Massachusetts | 02215 | — |
| UMASS Memorial Medical Center ( Site 0020) | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System ( Site 0023) | Detroit | Michigan | 48202 | — |
| Cancer and Hematology Centers of Western Michigan ( Site 0025) | Grand Rapids | Michigan | 49503 | — |
| Washington University School of Medicine ( Site 0027) | St Louis | Missouri | 63110 | — |
| Mount Sinai Hospital ( Site 0051) | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0032) | New York | New York | 10065 | — |
| AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058) | Pittsburgh | Pennsylvania | 15224 | — |
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 165 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04662710, 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 Apr 28, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04662710 live on ClinicalTrials.gov.