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NCT04949256 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
A Phase 3 study of Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 864
- Enrollment target
- 20
- Study locations
NCT04949256: Active Phase 3 study of Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme.
NCT04949256 is a Phase 3 study of Metastatic Esophageal Squamous Cell Carcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 864 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04949256, a Phase 3 study of Metastatic Esophageal Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 864 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma. The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). As of Amendment 09, Study MK-7902-014 will begin close out activities. Any participant who discontinues study intervention for any reason will be discontinued from the study without further follow-up. Second Course and treatment beyond disease progression will no longer be offered. No safety concerns contributed to the termination of this study.
Primary Outcome
A DLT is defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs are defined as 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. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting \>3 days (excluding nausea, vomiting, and d
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- DRUG Oxaliplatin
- DRUG Lenvatinib
- DRUG 5-FU
Study Locations (20)
New York
- Hematology-Oncology Associates of CNY ( Site 0173) - East Syracuse
- Memorial Sloan Kettering Cancer Center ( Site 0132) - New York
- Weill Cornell Medical College ( Site 0133) - New York
Buenos Aires
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203) - Berazategui
- IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202) - CABA
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205) - Mar del Plata
Kentucky
- James Graham Brown Cancer Center ( Site 0117) - Louisville
- Norton Cancer Institute ( Site 0116) - Louisville
Pennsylvania
- St. Luke's University Health Network ( Site 0185) - Bethlehem
- AHN Allegheny General Hospital ( Site 0164) - Pittsburgh
Santa Fe Province
- Fundacion Estudios Clinicos-Oncology ( Site 0215) - Rosario
- Sanatorio Parque ( Site 0206) - Rosario
California
- City of Hope ( Site 0102) - Duarte
District of Columbia
- MedStar Washington Hospital Center ( Site 0186) - Washington D.C.
Maryland
- Johns Hopkins Bayview Medical Center ( Site 0152) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 864 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2026-06-12 |
| Phase | Phase 3 |
What the registry record for NCT04949256 still lists
NCT04949256 is an interventional study that assigns participants to a tested intervention. The registered 864 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 (12% higher).
The record links to 1 condition, with Metastatic Esophageal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04949256 names 20 study sites across 13 states, led by New York, Buenos Aires, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04949256 about?
NCT04949256 is a clinical study titled "Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)". The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma. The primary hypotheses are that pembrolizumab plus lenvati...
What is the current status of trial NCT04949256?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 864 participants. The study started on 2021-07-28. Estimated completion is 2026-06-12.
What conditions does trial NCT04949256 study?
This clinical trial studies the following conditions: Metastatic Esophageal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04949256?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Oxaliplatin (DRUG), Lenvatinib (DRUG), 5-FU (DRUG).
Who is sponsoring clinical trial NCT04949256?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04949256 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
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Where NCT04949256's enrollment target sits among peer trials
864 378th of 2000 higher than 1,621 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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