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Study of Fianlimab and Cemiplimab for Patients with Untreated Advanced Melanoma

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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, specifically in patients who have not received prior treatment for advanced stages of the disease. The study is comparing the effectiveness of a new treatment combination of two medications, Fianlimab and Cemiplimab, against another medication called Pembrolizumab. Fianlimab is a solution for injection, while Cemiplimab and Pembrolizumab are concentrates for solution for infusion, which means they are given through a vein. The purpose of the study is to see if the combination of Fianlimab and Cemiplimab is better than Pembrolizumab in helping patients live longer without the cancer getting worse.

Participants in the study will receive either the combination of Fianlimab and Cemiplimab or Pembrolizumab. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for up to 24 months, during which time participants will receive regular treatments and check-ups to monitor their health and the progress of the melanoma. The study aims to gather information on how well the treatments work and their safety, including any side effects that may occur.

This trial is important for understanding how these medications can help people with melanoma, especially those who have not been treated before for advanced stages of the disease. By participating, researchers hope to find better ways to manage melanoma and improve the quality of life for patients. The study will also collect data on how the medications affect the body, including the presence of any antibodies, which are proteins made by the immune system in response to the medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of melanoma, and previous treatments.

    The study involves patients with advanced melanoma who have not received prior systemic therapy for their condition.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either a combination of fianlimab and cemiplimab or pembrolizumab alone.

    The objective is to compare the effectiveness of the combination therapy against pembrolizumab.

  3. Step 3

    Medication administration

    Fianlimab and cemiplimab are administered as a solution for infusion through a vein (intravenous use).

    Pembrolizumab is also given as a concentrate for solution for infusion intravenously.

    The frequency and dosage of these medications are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the body's response to the treatment.

    Assessments include measuring progression-free survival, overall survival, and response rates.

    Patient-reported outcomes are also evaluated to understand the impact on quality of life.

  5. Step 5

    Completion of the study

    The study is expected to continue until April 2031, with regular follow-ups and assessments throughout the duration.

    Upon completion, data collected will contribute to understanding the effectiveness and safety of the treatments.

Who can join the trial?

5 criteria

  • You must be at least 12 years old on the day you agree to join the study.
  • You should have a type of skin cancer called melanoma that is at an advanced stage (Stage III or IV) and cannot be removed by surgery. You should not have received any previous treatment for this advanced stage, except in certain cases where you had treatment before surgery or after surgery and did not have worsening of the disease.
  • Your cancer must be measurable according to specific guidelines. If you had radiation treatment before, those areas can only be counted if they have shown signs of getting worse and there are no other areas to measure.
  • You need to be in good physical condition. For adults, this means being able to carry out normal activities or being slightly limited. For children, they should be able to do most activities for their age.
  • You should be expected to live for at least 3 more months.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than melanoma cannot participate. Melanoma is a type of skin cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have received certain treatments for melanoma recently may not be eligible.
  • Patients who have an active infection or illness that requires treatment cannot participate.
  • Patients who have a history of certain heart conditions may not be eligible.
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Investigated drugs

  • Fianlimab (REGN3767, Anti-Lag-3)

    is an investigational medication being studied for its potential to help the immune system fight cancer. It works by targeting a specific protein called LAG-3, which can slow down the immune response. By blocking this protein, fianlimab may help the immune system better recognize and attack cancer cells.

  • Cemiplimab

    is a medication that helps the immune system fight cancer by targeting a protein called PD-1 on immune cells. By blocking this protein, cemiplimab can enhance the body's immune response against cancer cells, potentially slowing down or stopping the growth of tumors.

  • Pembrolizumab

    is a medication used to treat various types of cancer by boosting the immune system's ability to fight cancer cells. It works by blocking a protein called PD-1, which can inhibit the immune response. By blocking this protein, pembrolizumab helps the immune system recognize and attack cancer cells more effectively.

What is already known about the treatment

  • Fianlimab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating melanoma. It is not yet widely used in standard medical practice, as it is still under investigation. Fianlimab works by targeting and inhibiting the LAG-3 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Cemiplimab

    Administered through intravenous infusion, cemiplimab is an approved medication used in the treatment of certain types of skin cancer, including melanoma. It is well-documented in medical literature and is used to help the immune system fight cancer by blocking the PD-1 protein on immune cells. This action enhances the body's ability to detect and destroy cancer cells. Cemiplimab is also classified as an immune checkpoint inhibitor.

  • Pembrolizumab

    This medication is given via intravenous infusion and is widely used in the treatment of various cancers, including melanoma. It is well-established in medical practice and literature. Pembrolizumab works by blocking the PD-1 protein on immune cells, thereby boosting the immune response against cancer cells. It belongs to the class of immune checkpoint inhibitors.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. Melanoma can develop on any skin surface, but it is more common in areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. Early detection is crucial, as melanoma can be more effectively managed when identified in its initial stages. The disease is less common than other types of skin cancer but is more likely to grow and spread if not treated early.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505772-30-00Protocol codeR3767-ONC-2011Estimated enrolment1 590 patientsSponsorRegeneron Pharmaceuticals Inc.

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