This trial aims to look at how safe and effective a new combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda). The main outcome measured will be the number of patients who respond to treatment, and to what extent they respond.
This study is being conducted in Spain, Sweden, and the United States.
The details
Advanced or late-stage melanoma can be very difficult to treat. Often people can be treated with multiple different types of medication. A type of medication used to treat this kind of cancer is called a PDL1 inhibitor. Pembrolizumab is this kind of medication. Lenvatinib is another anti-cancer drug. It is not currently approved to treat melanoma.
This trial aims to look at how safe and effective is the combination of lenvatinib and pembrolizumab in patients with advanced melanoma. The main outcome measured will be the number of patients who respond to treatment, and to what extent they respond.
Who are they looking for?
The study is recruiting 100 patients that have previously been treated with a PDL1 inhibitor. Cancer must have progressed while on this treatment. Patients must not be planning on getting pregnant and must have good organ function. They must agree to use contraception for the study period and at least 120 days after the end of the study.
Patients will not be included in the trial if they have a reduced immune function or immune disorders requiring corticosteroids. They will be excluded if they are allergic to the trial drugs. Patients with cancer in the brain or nervous system, HIV, hepatitis, heart problems, tuberculosis, or cancer in the blood vessels, will be excluded. This must be the only trial patients are on.
How will it work
Everyone enrolled in the study will be taking the experimental treatment. Patients will receive a combination of lenvatinib and pembrolizumab for up to 2 years.
Patients will be followed up for response to treatment, survival and side effects for up to 3 years.
