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)

• Status: Recruiting
• Trial end date: 2025-12-29

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) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

• Phase: Phase 3

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Eisai Inc.
• Treatments: Calcium; Calcium, Dietary; Lenvatinib; Leucovorin; Levoleucovorin; Oxaliplatin; Pembrolizumab