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Study on Fianlimab and Cemiplimab for Adults with Resectable Stage III and IV 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 the treatment of Melanoma, a type of skin cancer. The study will explore the effectiveness and safety of a combination of two medications, Fianlimab and Cemiplimab, compared to using a single medication called Pembrolizumab. Fianlimab, also known by its code name REGN3767, is a solution for injection, while Cemiplimab is a concentrate for infusion. The trial aims to determine if the combination of Fianlimab and Cemiplimab works better than Pembrolizumab alone in treating patients with melanoma that can be surgically removed.

The study will be conducted in two phases. In the first phase, the focus will be on comparing the combination of Fianlimab and Cemiplimab to Cemiplimab alone to see how well they work as a treatment before and after surgery. The second phase will assess how long patients remain free of events like cancer recurrence when treated with the combination of Fianlimab and Cemiplimab compared to Pembrolizumab alone. The trial will involve regular monitoring and assessments to ensure the safety and effectiveness of the treatments.

Participants in the study will receive their assigned treatment and undergo various evaluations, including imaging tests like MRI to monitor the progress of their condition. The trial will help determine the best dose of Fianlimab to use in combination with Cemiplimab for future treatments. The study is expected to provide valuable information on the potential benefits of combining these medications for patients with resectable melanoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Assessment

    Undergo a complete physical examination and imaging studies. This includes a CT scan of the chest, abdomen, pelvis, and brain MRI. These tests confirm the stage of melanoma and ensure it is resectable.

    The pathology report must confirm the presence of melanoma, and the treatment plan, including surgery date, is documented.

  2. Step 2

    Randomization

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

    This step determines the specific treatment regimen to be followed during the trial.

  3. Step 3

    Treatment Administration

    Receive the assigned treatment through IV infusion. The specific medications and their combinations depend on the randomization outcome.

    The treatment is administered as a peri-operative therapy, meaning it is given around the time of surgery.

  4. Step 4

    Surgical Procedure

    Undergo surgery to remove the melanoma. The goal is to achieve complete resection with negative margins, meaning no cancer cells are left at the edges of the removed tissue.

  5. Step 5

    Post-Surgery Monitoring

    Regular follow-up visits are scheduled to monitor recovery and assess the effectiveness of the treatment.

    These visits include physical examinations and possibly additional imaging studies to check for any signs of cancer recurrence.

  6. Step 6

    Long-term Follow-up

    Continue to be monitored for several years to assess long-term outcomes such as event-free survival and overall survival.

    This phase includes evaluating any side effects or adverse events related to the treatment.

Who can join the trial?

7 criteria

  • Patients must have **melanoma**, a type of skin cancer.
  • Patients should be in **stage III** (IIIB, IIIC, IIID) or **stage IV** (M1a, M1b, M1c) according to the American Joint Committee on Cancer (AJCC) 8th edition. This means the cancer is advanced but can still be removed by surgery.
  • For those with stage III melanoma, the disease must be visible and confirmed as cancerous in a pathology report, which is a detailed examination of tissue samples.
  • Patients must be suitable for complete surgical removal of the cancer with the goal of curing it. The surgery should leave no cancerous tissue behind.
  • Before joining the study, patients need a full check-up and imaging tests like a **CT scan** (a detailed X-ray) of the chest, abdomen, and pelvis, and a **brain MRI** (a scan using magnets) to check for cancer spread.
  • Patients must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Other specific criteria defined in the study protocol may also apply.

Who cannot join the trial?

9 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 study has specific age requirements.
  • Patients who are not able to undergo surgery to remove the melanoma cannot participate. Resectable means the cancer can be surgically removed.
  • Patients who are part of a vulnerable population, which may include groups like children or pregnant women, cannot participate.
  • Patients who have other medical conditions that might interfere with the study treatment cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or are recovering from a major surgery cannot participate.
  • Patients who have a history of severe allergic reactions to similar medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

  • Fianlimab

    is an investigational medication being studied for its potential to help treat melanoma, a type of skin cancer. In this trial, it is used in combination with another medication to see if it can improve treatment outcomes for patients with melanoma that can be surgically removed.

  • Cemiplimab

    is a medication used to treat certain types of skin cancer, including melanoma. It works by helping the immune system recognize and attack cancer cells. In this trial, it is used both alone and in combination with fianlimab to evaluate its effectiveness in treating melanoma.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer by blocking a specific pathway that cancer cells use to hide from immune cells. In this trial, it is used as a comparison to the combination of fianlimab and cemiplimab to determine which treatment is more effective for patients with melanoma that can be surgically removed.

What is already known about the treatment

  • Fianlimab

    Fianlimab 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. The main therapeutic indication for fianlimab is melanoma, particularly in patients with resectable Stage III and IV melanoma. At the molecular level, fianlimab works by targeting specific proteins on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and attack cancer cells more effectively.

  • Cemiplimab

    Cemiplimab is administered intravenously and is currently approved for use in certain types of cancer, including melanoma, with ongoing research to expand its applications. It is primarily indicated for the treatment of melanoma, especially in patients with resectable Stage III and IV melanoma. Cemiplimab functions by blocking the PD-1 protein on immune cells, which helps to boost the immune system's ability to fight cancer. It belongs to the pharmacological class of immune checkpoint inhibitors, which are designed to enhance the immune system's response to cancer.

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, and it can be identified by its irregular shape, multiple colors, and larger size. Melanoma can grow quickly and has the potential to spread to other parts of the body if not detected early. The progression of melanoma involves the cancer cells invading deeper layers of the skin and potentially entering the lymphatic system or bloodstream. This spread can lead to the formation of new tumors in distant organs, a process known as metastasis. 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 IITrial ID2022-502825-17-00Protocol codeR3767-ONC-2208Estimated enrolment520 patientsSponsorRegeneron Pharmaceuticals Inc.

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