LEAP-015
Research type
Research Study
Full title
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
IRAS ID
1003467
Contact name
Taeyoun Jo
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2020-001990-53
Clinicaltrials.gov Identifier
Research summary
Gastric cancer is the fifth most common cancer in the world and is a major cause of cancer-related death.
Lenvatinib and pembrolizumab have been approved to treat people with different types of cancers. But they have not been approved to use with chemotherapies to treat gastroesophageal adenocarcinoma. This trial is being done to see how safe and effective lenvatinib plus pembrolizumab plus chemotherapy is compared to chemotherapy alone. The chemotherapies being used in this trial are standard treatments for people with this type of cancer.
About 790 male and female participants, aged 18 years and over, will take part in this study. To take part patients must have previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma. There is a screening phase to see if patients can join the study, this lasts about one month. Patients who are able to join the study are then put in one of the two treatment groups. Group 1: Lenvatinib + pembrolizumab + chemotherapy (CAPOX or mFOLFOX6) followed by lenvatinib + pembrolizumab and Group 2: Chemotherapy (CAPOX or mFOLOFOX6).
The treatment length depends on how long participant’s cancer responds to the trial drugs or if the trial doctor stops the drug(s) for a reason other than their cancer getting worse. Participants will be in the Treatment phase about 2 years. During this time, they will visit the hospital about 1 to 4 times every 6 weeks and may also have about 3 telephone or virtual visits. The Sponsor estimates that the study will require approximately 5 years from the time the first participant agrees to take part until the last participant’s last study-related contact.
This trial will take part at NHS hospitals in the UK.
The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD).
REC name
HSC REC A
REC reference
21/NI/0071
Date of REC Opinion
8 Jun 2021
REC opinion
Further Information Favourable Opinion