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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 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. The trial reports 20 study locations across 12 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04662710
The ClinicalTrials.gov registry entry for NCT04662710 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 895 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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