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NCT04662710 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Advanced/Metastatic Gastroesophageal Adenocarcinoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 895
- Enrollment target
- 20
- Study locations
NCT04662710: Active Phase 3 study of Advanced/Metastatic Gastroesophageal Adenocarcinoma, sponsored by Merck Sharp & Dohme.
NCT04662710 is a Phase 3 study of Advanced/Metastatic Gastroesophageal Adenocarcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 895 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04662710, a Phase 3 study of Advanced/Metastatic Gastroesophageal Adenocarcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 895 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
A DLT was defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs included Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Nonhematologic DLTs included any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, and diarrhea controlled by medical int
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Capecitabine
- DRUG Oxaliplatin
- BIOLOGICAL Lenvatinib
- DRUG Leucovorin (or Levoleucovorin)
Study Locations (20)
Other
- Fundacion Favaloro ( Site 0201) - Buenos Aires
- Hospital Aleman ( Site 0210) - Buenos Aires
- Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207) - Buenos Aires
- CEMIC ( Site 0209) - Buenos Aires
- Hospital Privado de Cordoba ( Site 0204) - Córdoba
Massachusetts
- Dana Farber Cancer Center ( Site 0019) - Boston
- UMASS Memorial Medical Center ( Site 0020) - Worcester
Michigan
- Henry Ford Health System ( Site 0023) - Detroit
- Cancer and Hematology Centers of Western Michigan ( Site 0025) - Grand Rapids
New York
- Mount Sinai Hospital ( Site 0051) - New York
- Memorial Sloan Kettering Cancer Center ( Site 0032) - New York
Buenos Aires
- IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202) - Caba
- Instituto Medico Alexander Fleming ( Site 0208) - Ciudad Autonoma de Buenos Aires
California
- UCLA Hematology/Oncology - Santa Monica ( Site 0003) - Los Angeles
District of Columbia
- Georgetown University Medical Center ( Site 0009) - Washington D.C.
Kentucky
- James Graham Brown Cancer Center ( Site 0017) - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 895 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What the registry record for NCT04662710 still lists
NCT04662710 is an interventional study that assigns participants to a tested intervention. The registered 895 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Advanced/Metastatic Gastroesophageal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04662710 names 20 study sites across 12 states, led by Other, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT04662710 about?
NCT04662710 is a clinical study titled "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)". 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 pembro...
What is the current status of trial NCT04662710?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 895 participants. The study started on 2020-12-30. Estimated completion is 2026-03-31.
What conditions does trial NCT04662710 study?
This clinical trial studies the following conditions: Advanced/Metastatic Gastroesophageal Adenocarcinoma.
What interventions are being tested in trial NCT04662710?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG), Oxaliplatin (DRUG), Lenvatinib (BIOLOGICAL), Leucovorin (or Levoleucovorin) (DRUG).
Who is sponsoring clinical trial NCT04662710?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04662710 being conducted?
This trial has 20 study locations across California, District of Columbia, Kentucky, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04662710's enrollment target sits among peer trials
895 361st of 2000 higher than 1,638 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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