Trial Purpose

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 Tumours 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.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT04662710

When speaking to your doctor, please have the trial identifier number available.

About The Study

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Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.

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Dates

  • Actual study start date 30 December 2020
  • Estimated primary completion date 31 December 2024
  • Estimated study completion date 31 December 2024

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

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Conditions

Advanced/Metastatic Gastroesophageal Adenocarcinoma

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.