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Study to Compare Fianlimab and Cemiplimab Combination with Pembrolizumab in Patients with High-Risk Melanoma After Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining 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.

  2. Step 2

    Treatment 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.

  3. Step 3

    Monitoring 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.

  4. Step 4

    Completion 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 trial?

6 criteria

  • 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 trial?

8 criteria

  • 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.
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Investigated 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.

What is already known about the treatment

  • Fianlimab

    Fianlimab is administered as an injection and is currently being studied in clinical trials for its potential use in treating melanoma, a type of skin cancer. It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for fianlimab is to help prevent the return of melanoma after surgery. At the molecular level, fianlimab works by blocking a protein called LAG-3, which can help the immune system better recognize and attack cancer cells. It is classified as an immunotherapy drug.

  • Cemiplimab

    Cemiplimab is given as an injection and is being researched in clinical trials for its effectiveness in treating melanoma. It is already approved for use in some other types of cancer, but its role in melanoma is still being explored. The primary use of cemiplimab in this trial is to prevent melanoma from coming back after it has been surgically removed. It works by targeting a protein called PD-1, which helps the immune system detect and destroy cancer cells. Cemiplimab is part of a group of drugs known as immune checkpoint inhibitors.

  • Pembrolizumab

    Pembrolizumab is administered through an injection and is a well-established medication used in the treatment of various cancers, including melanoma. In this trial, it serves as a comparison to newer treatments. Its main use is to prevent the recurrence of melanoma after surgery. Pembrolizumab functions by blocking the PD-1 protein, thereby enhancing the immune system's ability to fight cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501576-25-00Protocol codeR3767-ONC-2055Estimated enrolment1 530 patientsSponsorRegeneron Pharmaceuticals Inc.

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