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).
Public ClinicalTrials.gov record NCT04949256. 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
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.
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 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.
Study identification
- NCT ID
- NCT04949256
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 863 participants
Conditions and interventions
Interventions
- Pembrolizumab Biological
- Lenvatinib Drug
- Cisplatin Drug
- 5-FU Drug
- Oxaliplatin Drug
- Leucovorin Drug
- Levoleucovorin Drug
- Paclitaxel 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
- Jul 27, 2021
- Primary completion
- May 7, 2025
- Completion
- May 19, 2026
- Last update posted
- Aug 20, 2026
2021 – 2026
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope ( Site 0102) | Duarte | California | 91010 | — |
| MedStar Washington Hospital Center ( Site 0186) | Washington D.C. | District of Columbia | 20010 | — |
| James Graham Brown Cancer Center ( Site 0117) | Louisville | Kentucky | 40202 | — |
| Norton Cancer Institute ( Site 0116) | Louisville | Kentucky | 40217 | — |
| Johns Hopkins Bayview Medical Center ( Site 0152) | Baltimore | Maryland | 21224 | — |
| UMASS Memorial Medical Center ( Site 0120) | Worcester | Massachusetts | 01655 | — |
| Capital Health Medical Center - Hopewell ( Site 0189) | Pennington | New Jersey | 08534 | — |
| Hematology-Oncology Associates of CNY ( Site 0173) | East Syracuse | New York | 13057 | — |
| Memorial Sloan Kettering Cancer Center ( Site 0132) | New York | New York | 10065 | — |
| Weill Cornell Medical College ( Site 0133) | New York | New York | 10065 | — |
| St. Luke's University Health Network ( Site 0185) | Bethlehem | Pennsylvania | 18015 | — |
| AHN Allegheny General Hospital ( Site 0164) | Pittsburgh | Pennsylvania | 15212 | — |
| Medical University of South Carolina-Hollings Cancer Center ( Site 0177) | Charleston | South Carolina | 29425 | — |
| VCU Health Adult Outpatient Pavillion ( Site 0160) | Richmond | Virginia | 23219 | — |
| Seattle Cancer Care Alliance ( Site 0145) | Seattle | Washington | 98109 | — |
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 183 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04949256, 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 Aug 20, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04949256 live on ClinicalTrials.gov.