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NCT04949256 · ClinicalTrials.gov record · last posted 2026-08-21

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).

StatusTerminated
PhasePhase 3
Started2021-07-28
View on ClinicalTrials.gov ↗
Why the trial stopped
Trial was rendered as cancelled work ongoing in the book of business.
from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-22
Reclassified as terminated (was completed)
2026-08-22
Trial terminated: Trial was rendered as cancelled work ongoing in the book of business.
Trial Details
NCT Number NCT04949256
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Eisai Inc.
Conditions Metastatic Esophageal Squamous Cell Carcinoma
Enrollment 863 participants
Start Date 2021-07-28
Primary Completion 2025-05-08 (estimated)
Study Completion 2026-05-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-21