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)

3期 已完成 NCT04949256

摘要

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.

Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)

Up to 21 days · Participants

Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)

Up to 43 months · Participants

Part 1 (FP and TP Safety Run-in): Number of Participants Who Discontinued Study Treatment Due to an AE

Up to 22 months · Participants

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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