LEAP-015 (MK-7902-015)

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.

Patient Profile

Previously untreated advanced/ metastatic HER-2 negative gastric/ gasto-esophageal junction (GEJ) cancer

Where’s this trial being run?

Beaumont Hospital

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.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

Print this page

For more detailed information

Click Here

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

---

Summary Data

Name:	LEAP-015 (MK-7902-015)
Number:	21-34
Full Title:	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)
Type:	Industry Sponsored
Sponsor:	Merck Sharp & Dohme (MSD)
Recruitment Started:	Global: December 2020 Ireland: October 2021

Global Recruitment Target:	778
Ireland Recruitment Target:	20