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Study on Cemiplimab for Patients with High-Risk Stage III/IV Cutaneous Squamous Cell Carcinoma

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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 known as Cutaneous Squamous Cell Carcinoma, specifically in patients with high-risk stage III or IV cancer that can be surgically removed. The treatment being investigated is called Cemiplimab, which is a type of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer. In this study, Cemiplimab is given to patients both before and after surgery to see if it can help reduce the risk of the cancer coming back.

The purpose of the study is to explore whether using Cemiplimab before and after surgery can have anti-tumor effects and lower the chances of the cancer returning. Patients will receive Cemiplimab through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of time, during which patients will be monitored to see how well the treatment works and to check for any side effects. The study aims to understand how the treatment affects the cancer and the patient's overall health.

Throughout the study, researchers will look at various outcomes, such as how many cancer cells remain after treatment, how long patients stay free from cancer recurrence, and overall survival rates. They will also assess the safety of the treatment and examine changes in the cancer and blood to identify any new markers that could help in future treatments. This research is important for finding better ways to treat high-risk cutaneous squamous cell carcinoma and improve patient outcomes.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility criteria include being 18 years or older, having surgically resectable, high-risk stage III/IV (M0) cutaneous squamous cell carcinoma, and being medically fit for surgery.

  2. Step 2

    Neoadjuvant treatment

    The neoadjuvant phase involves receiving cemiplimab through an intravenous infusion. This is an immunotherapy treatment aimed at reducing the tumor size before surgery.

    The dosage and frequency of cemiplimab administration are determined by the study protocol and are monitored by the medical team.

  3. Step 3

    Surgical procedure

    After completing the neoadjuvant treatment, a surgical procedure is performed to remove the tumor. The surgery is planned and executed by a surgical oncology team.

    The goal of the surgery is to achieve a major pathological response, which means having less than 10% of viable tumor cells remaining in the resected tissue.

  4. Step 4

    Adjuvant treatment

    Following surgery, the adjuvant phase begins, which involves additional cemiplimab treatment to help prevent cancer recurrence.

    This phase is crucial for improving recurrence-free survival, which is the time from the start of treatment until the disease returns or the patient passes away from any cause.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health status and detect any signs of cancer recurrence. These visits include physical exams and possibly imaging tests.

    The study also aims to evaluate overall survival, which is the duration from diagnosis or treatment start until the patient is still alive.

Who can join the trial?

16 criteria

  • Patients must be at least 18 years old.
  • Patients must be able to give written consent, agreeing to follow the study's rules.
  • Patients must have a type of skin cancer called **cutaneous squamous cell carcinoma** that can be surgically removed and is considered high risk at stage III or IV (M0). This means the cancer hasn't spread to other parts of the body. The ability to remove the tumor surgically will be confirmed by a team of cancer specialists.
  • Patients must be healthy enough to have surgery, as decided by the surgical team.
  • Patients must have a measurable disease, which means the cancer can be measured using specific criteria called **RECIST 1.1**.
  • Patients must have a good general health status, known as **ECOG performance status 0-1**, which indicates they are fully active or have some symptoms but do not need bed rest.
  • Patients must have normal organ and bone marrow function, which includes specific blood test results such as:
    • **Absolute neutrophil count (ANC)** of at least 1.5 x 10^9/L
    • **Hemoglobin** level of at least 9.5 g/dL
    • **Platelets** count of at least 100 x 10^9/L
    • **Prothrombin time/international normalized ratio (PT/INR)** and **partial thromboplastin time (PTT)** within 1.5 times the normal limit
    • **Total bilirubin** within 1.5 times the normal limit (higher levels are acceptable if direct bilirubin is less than 35%)
    • **Aspartate aminotransferase (AST)** and **alanine aminotransferase (ALT)** within 2.5 times the normal limit
    • **Albumin** level of at least 2.5 g/dL
    • **Creatinine** within 1.5 times the normal limit or a creatinine clearance of at least 50 mL/min
    • Women who can have children must have a negative pregnancy test before starting and use reliable birth control during the study and for 6 months after the last dose of the study drug, **cemiplimab**.
    • Men who are sexually active with women who can have children must use reliable birth control during the study and for 6 months after the last dose of **cemiplimab**.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer besides Cutaneous Squamous Cell Carcinoma cannot participate. This is a type of skin cancer.
  • Patients whose cancer cannot be surgically removed are not eligible. Surgically resectable means the cancer can be removed by surgery.
  • Patients with cancer that has spread to other parts of the body (metastasis) are excluded. Stage III/IV (M0) means the cancer is advanced but has not spread to distant parts of the body.
  • Patients who are not considered high risk for cancer recurrence are not eligible. High risk means there is a greater chance the cancer could come back after treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is for adults.
  • Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not included in this study.
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Investigated drugs

Cemiplimab is an immunotherapy medication used in this clinical trial. It is being tested for its ability to help the body's immune system fight cancer cells in patients with high-risk stage III or IV cutaneous squamous cell carcinoma that can be surgically removed. The study aims to see if using Cemiplimab before and after surgery can reduce the chance of the cancer coming back.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating high-risk stage III/IV cutaneous squamous cell carcinoma that is surgically resectable. The main therapeutic indication for Cemiplimab is to reduce the risk of cancer relapse by using it as both a neoadjuvant and adjuvant treatment. At the molecular level, Cemiplimab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immunotherapy drug, specifically a PD-1 inhibitor.

Investigated diseases

Cutaneous Squamous Cell Carcinoma – This is a type of skin cancer that originates in the squamous cells, which are flat cells found in the outer layer of the skin. It typically appears as a rough, scaly patch or a sore that may bleed or crust over. The disease progresses by growing slowly and can spread to other parts of the body if not treated. It is more common in areas of the skin that are frequently exposed to sunlight, such as the face, ears, and hands. The risk of developing this cancer increases with age, prolonged sun exposure, and a history of sunburns. Early detection and surgical removal are crucial to prevent further spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515204-39-00Protocol codeNEO-CESQEstimated enrolment25 patientsSponsorFondazione Melanoma Onlus

sourced from the EU Clinical Trials Register and site verification

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