NCT04949256

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, 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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 864 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed. In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.

Conditions

• Metastatic Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	400 mg once every 6-week-cycle, via IV infusion.
DRUG	Lenvatinib	8 mg QD (Induction) or 20 mg QD (Consolidation) via oral capsule.
DRUG	Cisplatin	80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
DRUG	5-FU	4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
DRUG	Oxaliplatin	85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
DRUG	Leucovorin	400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
DRUG	Levoleucovorin	200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
DRUG	Paclitaxel	175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.

Timeline

• Start date: 2021-07-28
• Primary completion: 2025-05-08
• Completion: 2026-06-12
• First posted: 2021-07-02
• Last updated: 2025-12-15

Locations

198 sites across 25 countries: United States, Argentina, Canada, Chile, China, Costa Rica, Denmark, France, Guatemala, Hong Kong, Hungary, Italy, Japan, Malaysia, Romania, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study