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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)
NCT04949256 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04949256
The ClinicalTrials.gov registry entry for NCT04949256 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 864 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04949256 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Buenos Aires, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04949256?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Oxaliplatin (DRUG), Lenvatinib (DRUG), 5-FU (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04949256?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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