The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Up to ~21 days
Part 1: Number of Participants With Adverse Events (AEs)
Timeframe: Up to ~44 months
Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE
Timeframe: Up to ~29 months
Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Timeframe: Up to ~41 months
Part 2: OS in All Participants
Timeframe: Up to ~41 months
Part 2: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
Timeframe: Up to ~29 months
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
Timeframe: Up to ~29 months