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Study of Cemiplimab Compared to Placebo After Surgery and Radiation for Patients with High-Risk Skin 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 (CSCC). The study is investigating the effects of a treatment called Cemiplimab, which is also known by its code name R2810. Cemiplimab is a medication given as an infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the outcomes of patients receiving Cemiplimab with those receiving a placebo, which is a substance with no active medication, after they have undergone surgery and radiation therapy.

The purpose of the study is to see if Cemiplimab can help prevent the return of cancer in patients who are at high risk of their cancer coming back after initial treatment. Participants in the study will be randomly assigned to receive either Cemiplimab or a placebo. The study will monitor patients over time to see how long they remain free of cancer and to track their overall health and survival. The trial will also look at the safety of Cemiplimab by observing any side effects or health changes that occur during the study.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the status of their cancer. The study aims to provide valuable information on whether Cemiplimab can be an effective additional treatment for patients with high-risk CSCC, potentially improving their chances of staying cancer-free after surgery and radiation therapy.

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

    Randomization

    After completing surgery and radiation therapy, the patient is randomly assigned to one of two groups: one receiving cemiplimab and the other receiving a placebo.

    This process ensures that each patient has an equal chance of receiving either treatment.

  2. Step 2

    Treatment administration

    The patient receives the assigned treatment through an intravenous infusion.

    The treatment consists of LIBTAYO 350 mg concentrate for solution for infusion or a matching placebo.

    The frequency and duration of the treatment are determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    The patient's health is monitored regularly to assess the effectiveness of the treatment and to identify any side effects.

    Regular check-ups include blood tests and other necessary examinations to ensure the patient's safety.

  4. Step 4

    Evaluation of outcomes

    The primary outcome measured is disease-free survival (DFS), which is the time from randomization to the first documented recurrence of the disease or death from any cause.

    Secondary outcomes include overall survival, freedom from locoregional and distant recurrence, and the occurrence of new primary tumors.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by March 25, 2029.

    Upon completion, the data collected will be analyzed to determine the effectiveness and safety of cemiplimab compared to the placebo.

Who can join the trial?

7 criteria

  • The patient must have had surgery to remove a confirmed case of **Cutaneous Squamous Cell Carcinoma (CSCC)**. This can be the main skin cancer lesion, the main lesion with cancer spread to nearby lymph nodes, or cancer spread to lymph nodes with a known main lesion that was treated before.
  • The patient must have a **high-risk** form of CSCC.
  • The patient must have completed radiation therapy aimed at curing the cancer within 2 to 10 weeks before being randomly assigned to a treatment group in the study.
  • The patient must have an **Eastern Cooperative Oncology Group performance status (ECOG PS)** of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must have adequate liver, kidney, and bone marrow function as defined in the study protocol. This means the organs are working well enough to safely participate in the study.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered vulnerable, meaning they might need extra protection or care during the study.

Who cannot join the trial?

10 criteria

  • Patients who have not had surgery and radiation therapy for their skin cancer.
  • Patients who have other types of cancer, not just cutaneous squamous cell carcinoma.
  • Patients who have a serious infection or illness that could affect their participation.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who have received another experimental treatment within a certain time frame before the study.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of certain heart conditions or other serious health issues.
  • Patients who are taking medications that could interfere with the study treatment.
  • Patients who have a history of drug or alcohol abuse that could affect their participation.
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Investigated drugs

Cemiplimab is a medication being studied for its potential to help patients with high-risk cutaneous squamous cell carcinoma. It is used after surgery and radiation therapy to see if it can improve the time patients remain free from the disease. This medication works by helping the immune system to better recognize and attack cancer cells.

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 cutaneous squamous cell carcinoma (CSCC) after surgery and radiation therapy. The main therapeutic indication for cemiplimab is to improve disease-free survival in patients with this type of skin cancer. At the molecular level, cemiplimab works by blocking a protein called PD-1 on immune cells, which helps the immune system to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy used in cancer treatment.

Investigated diseases

Cutaneous Squamous Cell Carcinoma – This is a type of skin cancer that originates in the squamous cells, which are flat cells located in the outer part of the skin. It often appears as a rough, scaly patch or a sore that may bleed or crust over. The disease can develop on any part of the body but is most commonly found in areas frequently exposed to the sun, such as the face, ears, neck, and hands. Over time, the carcinoma can grow larger and may spread to other parts of the body if not treated. It is generally more aggressive than basal cell carcinoma but less so than melanoma. Early detection and management are crucial to prevent further progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511653-22-00Protocol codeR2810-ONC-1788Estimated enrolment355 patientsSponsorRegeneron Pharmaceuticals Inc.

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