About this trial
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902), an anti-cancer medication previously approved in the treatment of thyroid cancers, plus pembrolizumab (MK-3475), a cell death antibody, plus chemotherapy. This will be 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 radiologically assessed tumour response. This is a Phase 3, Randomized, Open-label Study. Meaning you could be treated with lenvatinib plus pembrolizumab plus chemotherapy or you could be treated to chemotherapy alone. You will told which study treatment you are assigned to.
|Previously untreated advanced/ metastatic HER-2 negative gastric/ gasto-esophageal junction (GEJ) cancer|
Where’s this trial being run?
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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Here’s a list of questions you may have for your doctor or local cancer research team.Questions
A Phase 3, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Pembrolizumab plus Lenvatinib plus Chemotherapy Induction Therapy Followed by Pembrolizumab plus Lenvatinib Compared with Chemotherapy in Participants with Previously Untreated Advanced/Metastatic HER2 Negative Gastric/Gastroesophageal Junction Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015
|Principal Investigator:||Dr Adrian Murphy (Beaumont Hospital)|
Merck Sharp & Dohme (MSD)
Global: December 2020
Ireland: October 2021
|Global Recruitment Target:||778|
|Ireland Recruitment Target:||20|