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A Study of Cemiplimab Given Before Surgery in Patients with Early Stage Merkel Cell Carcinoma of the Skin

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What is this trial about?

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

This study involves patients with Merkel cell carcinoma, which is a rare and aggressive type of skin cancer. The study will test a treatment called Cemiplimab, which is also known by its code name REGN2810. This medication is a type of drug that works by blocking a protein called PD-1, which can help the body's immune system fight cancer cells. Some patients in the study will receive Cemiplimab while others will receive a placebo. The medication will be given through an infusion into a vein, and patients will receive up to 700 milligrams over the course of their treatment.

The purpose of this study is to evaluate how well Cemiplimab works when given before a procedure called a sentinel lymph node biopsy, which is a test to check if cancer has spread to nearby lymph nodes. The study will measure whether this treatment helps prevent the presence of tiny cancer spread in the lymph nodes. Patients in this study will have already had their primary tumor removed and will be scheduled for the lymph node biopsy. The study will also look at how long patients remain free from cancer coming back, how long patients survive, and how the treatment affects their quality of life.

During the study, patients will receive two cycles of treatment before their lymph node biopsy. The study will collect tissue samples from the original tumor site and from the lymph node biopsy to examine how the treatment affects the cancer. Safety will be monitored throughout the study by tracking any side effects that occur. The study will also compare outcomes between patients who receive Cemiplimab and those who receive placebo, looking at factors such as whether cancer returns, survival rates, and overall well-being using questionnaires.

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

    Initial treatment phase

    After joining the study, you will receive either cemiplimab or a placebo (an inactive substance). This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving.

    Cemiplimab is a type of medication called a PD-1 inhibitor, which works by helping your immune system fight cancer cells.

    The treatment will be given intravenously, meaning through a vein in your arm.

    You will receive 2 cycles of treatment before the next procedure.

  2. Step 2

    Sentinel lymph node biopsy

    After completing the 2 cycles of treatment, you will undergo a sentinel lymph node biopsy.

    A sentinel lymph node biopsy is a procedure where the first lymph node to which cancer cells are likely to spread from the primary tumor is removed and examined.

    The tissue samples from your primary tumor and the lymph node will be analyzed for the study.

  3. Step 3

    Follow-up period

    After the sentinel lymph node biopsy, you will enter a follow-up period where your health will be monitored.

    During this period, assessments will be made to check for any signs of cancer returning or progressing.

    Your quality of life will be evaluated using questionnaires throughout the study.

  4. Step 4

    Safety monitoring

    Throughout the entire study, any side effects or health changes you experience will be recorded and evaluated.

    This monitoring will continue during and after your treatment to ensure your safety.

Who can join the trial?

13 criteria

  • You must have signed a written consent form agreeing to participate in the study.
  • You must be 18 years old or older at the time you sign the consent form.
  • You must have been diagnosed with Merkel cell carcinoma, which is a rare type of skin cancer. Your cancer should be in clinical stage II, or in stage I with a tumor size of at least 1 centimeter. The main tumor must have already been removed by surgery, and you must still be scheduled to have a sentinel lymph node biopsy, which is a procedure to check if cancer has spread to nearby lymph nodes.
  • Your ECOG performance status must be between 0 and 2. This is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 2 means you can care for yourself but cannot work.
  • Your blood test results must meet certain requirements:
    • Your neutrophil count (a type of white blood cell that fights infection) must be at least 1.5 x 10⁹ per liter.
    • Your platelet count (cells that help blood clot) must be at least 75 x 10⁹ per liter.
    • Your hemoglobin level (a protein in red blood cells that carries oxygen) must be at least 9 grams per deciliter.
    • Your total bilirubin (a substance produced when red blood cells break down) must not be more than 1.5 times the upper normal limit. If you have Gilbert's Disease, a harmless liver condition, you may be eligible with bilirubin up to 3 times the upper limit after approval.
    • Your AST and ALT (liver enzymes that show how well your liver is working) must not be more than 3 times the upper normal limit.
    • Your alkaline phosphatase (an enzyme found in the liver and bones) must not be more than 2.5 times the upper normal limit.
    • Your serum creatinine (a waste product that shows how well your kidneys are working) must not be more than 2 times the upper normal limit, or your creatinine clearance (a measure of kidney function) must be at least 40 milliliters per minute.
    • If you are a woman who can become pregnant, or a man with a female partner who can become pregnant, you must agree to either avoid sexual intercourse or use highly effective birth control methods with less than 1% failure rate during treatment and for at least 6 months after receiving the last dose of the study medication. Men must also agree not to donate sperm during this time. Men with pregnant partners must agree to avoid sexual intercourse or use condoms throughout the pregnancy.
    • You must be willing to allow researchers to use your tissue samples from the removed tumor and the sentinel lymph node biopsy for research purposes.

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
  • Exclusion criteria are conditions or factors that would prevent someone from joining a study, but these details are not available in the provided information
  • Without this information, it is not possible to list the specific reasons that would make a patient ineligible for this particular study
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Investigated drugs

  • Cemiplimab

    is a type of immunotherapy medication that works by helping your immune system fight cancer. It blocks a protein called PD-1 on immune cells, which allows your body's natural defenses to recognize and attack cancer cells more effectively. In this study, it is being tested as a treatment given before surgery in patients with Merkel cell carcinoma, which is a rare type of skin cancer.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in research studies to compare the effects of the actual medication against no treatment, helping researchers understand if the medication is truly effective.

What is already known about the treatment

Cemiplimab – Cemiplimab is a medication given through injection into a vein that works by blocking a protein called PD-1, which helps the body's immune system recognize and fight cancer cells more effectively. It is an approved immunotherapy drug used primarily for treating Merkel cell carcinoma, a rare and aggressive type of skin cancer. In this clinical trial, researchers are studying whether giving Cemiplimab before surgery (neoadjuvant treatment) can improve outcomes for patients with early-stage Merkel cell carcinoma. This drug belongs to a class of medications known as immune checkpoint inhibitors or PD-1 inhibitors.

Investigated diseases

Merkel Cell Carcinoma – Merkel cell carcinoma is a rare and aggressive type of skin cancer that develops in Merkel cells, which are found in the top layer of the skin near nerve endings. The disease typically appears as a firm, painless nodule or lump on sun-exposed areas of the body, such as the head, neck, or arms. The tumor usually grows rapidly and has a flesh-colored, red, or bluish appearance. As the disease progresses, the cancer cells can spread to nearby lymph nodes in the region. If left untreated, the cancer may continue to spread to other lymph nodes and distant organs throughout the body. The disease is more common in older adults and people with weakened immune systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522091-84-00Protocol codeNeoMatryxEstimated enrolment135 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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