LEAP-014
Research type
Research Study
Full title
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared with Standard of Care as First-line Intervention in Participants with Metastatic Esophageal Carcinoma
IRAS ID
1003955
Contact name
Racquel Weaver
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
Eudract number
2020-001911-26
Clinicaltrials.gov Identifier
Research summary
Oesophageal cancer is the seventh most commonly diagnosed cancer worldwide and the sixth most common 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 oesophageal cancer. This trial is being done to see how safe and effective lenvatinib plus pembrolizumab with chemotherapy is compared to pembrolizumab with chemotherapy. The chemotherapies being used in this trial are standard treatments for people with this type of cancer.
About 862 participants, aged 18 years and over, will take part in this study. To take part patients must have previously untreated advanced oesophageal cancer. There is a screening phase to see if patients can join the study, this lasts about one month. UK patients who are able to join the study will then be put in one of the two treatment groups.
Group 1: Lenvatinib + pembrolizumab + chemotherapy (FP or mFOLFOX6) for 12 weeks, followed by lenvatinib + pembrolizumab.
Group 2: Pembrolizumab + chemotherapy (FP 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 may be in the Treatment phase about 2 years. During this time, they will visit the hospital about 1 to 3 times every 3 weeks and will also have at least 2 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
Wales REC 1
REC reference
21/WA/0232
Date of REC Opinion
14 Sep 2021
REC opinion
Further Information Favourable Opinion