This clinical trial is focused on studying a type of skin cancer called melanoma. The study aims to find out if a combination of two medications, fianlimab and cemiplimab, is more effective than another medication called pembrolizumab in preventing or delaying the return of melanoma after it has been completely removed through surgery. Fianlimab is also known by its code name REGN3767, and cemiplimab is sometimes referred to as REGN2810. Pembrolizumab is also known by the code names MK-3475 and Lambrolizumab.
The purpose of the study is to see if the combination of fianlimab and cemiplimab can improve the time patients remain free from melanoma returning, which is known as relapse-free survival. Participants in the study will receive either the combination of fianlimab and cemiplimab or pembrolizumab alone. The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will last for a period of up to 51 weeks, during which the effects of the treatments will be monitored.
Throughout the study, researchers will observe how well the treatments work in keeping melanoma from coming back and will also monitor for any side effects or adverse reactions. The study will help determine if the new combination of medications offers a better option for patients who have had melanoma surgically removed. The ultimate goal is to improve the chances of staying cancer-free for a longer period after surgery.
1joining the trial
Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive a combination of fianlimab and cemiplimab, while the other group will receive pembrolizumab.
This assignment is random, meaning it is like flipping a coin to decide which treatment you will receive.
2treatment administration
If you are in the group receiving fianlimab and cemiplimab, these medications will be given to you through an intravenous infusion. This means the medicine will be delivered directly into your bloodstream through a vein.
If you are in the group receiving pembrolizumab, this medication will also be administered through an intravenous infusion.
The exact dosage and frequency of these infusions will be determined by the study protocol and your healthcare team.
3monitoring and follow-up
Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. This will include physical examinations and imaging studies.
You will be asked to report any side effects or changes in your health to the study team.
4completion of the trial
The trial is expected to continue until April 2028. Your participation may last for a different duration depending on your individual circumstances and the study’s requirements.
At the end of your participation, you will have a final evaluation to assess your health and the outcomes of the treatment.
Who Can Join the Study?
Patients must have melanoma that is completely removed by surgery. Melanoma is a type of skin cancer.
The melanoma must be classified as stage IIB, IIC, III, or IV according to the American Joint Committee on Cancer (AJCC) 8th edition. These stages describe the extent of the cancer.
Surgery to remove the melanoma must have been done within 12 weeks before joining the study, and the surgical wound must be healed.
Patients must be disease-free, meaning no signs of cancer, as confirmed by a full physical exam and imaging tests within 4 weeks before joining the study.
Both male and female patients can participate.
Patients of all age groups are eligible.
Who Cannot Join the Study?
Patients who have a different type of cancer other than melanoma.
Patients who are not within the specified age range for the study.
Patients who are not able to give informed consent or understand the study requirements.
Patients who are pregnant or breastfeeding.
Patients who have a serious medical condition that might interfere with the study.
Patients who have participated in another clinical trial recently.
Patients who have an allergy or severe reaction to the study drugs.
Patients who are taking medications that might interfere with the study drugs.
Fianlimab is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein called LAG-3, which can slow down the immune system’s ability to attack cancer cells. By blocking this protein, fianlimab may help the immune system work better in finding and destroying cancer cells, particularly in patients who have had surgery to remove melanoma, a type of skin cancer.
Cemiplimab is another medication used in this trial that helps the immune system target and destroy cancer cells. It is known as an immune checkpoint inhibitor, which means it helps the immune system recognize and attack cancer cells more effectively. Cemiplimab is used in combination with fianlimab to see if the two medications together can improve outcomes for patients with high-risk melanoma after surgery.
Pembrolizumab is a medication that is already used to treat various types of cancer, including melanoma. It also works as an immune checkpoint inhibitor, helping the immune system to better identify and attack cancer cells. In this trial, pembrolizumab is being used as a comparison to see if the combination of fianlimab and cemiplimab is more effective in preventing the return of melanoma after surgery.
Melanoma – Melanoma is a type of skin cancer that originates in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often begins as a mole that changes in size, shape, or color, but it can also appear on skin that looks normal. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is known for its ability to metastasize, or spread, rapidly if not detected early. Melanoma can occur on any skin surface, but it is more common in areas exposed to the sun, such as the back, legs, arms, and face. Early detection and monitoring of changes in the skin are crucial in managing the progression of melanoma.
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