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Study of Cemiplimab for Patients with Stage II to 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 (CSCC), specifically in stages II to IV. The treatment being investigated is a medication called cemiplimab, which is also known by its code name REGN2810. Cemiplimab is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective cemiplimab is when used before surgery to treat CSCC.

Participants in the study will receive cemiplimab before undergoing surgery. The study will monitor how well the cancer responds to the treatment by looking at the cancer cells under a microscope after surgery. This is known as a pathologic complete response. The study will also track other outcomes, such as how long participants live without the cancer coming back, any changes in the surgical plan, and any side effects experienced during the treatment.

The study aims to provide valuable information about the potential benefits of using cemiplimab as a pre-surgery treatment for CSCC. By understanding how the cancer responds to this treatment, researchers hope to improve future treatment options for patients with this type of skin cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the effectiveness of cemiplimab.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking the stage of the skin cancer, ensuring it is stage II to IV cutaneous squamous cell carcinoma, and verifying that surgery would be recommended in routine clinical practice.
A measurable lesion of at least 3 cm in the longest diameter is required for stage II patients. The assessment also includes evaluating overall health status using the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1, indicating full activity or some symptoms but nearly fully ambulatory.
Step 2
Treatment with cemiplimab
The treatment phase involves receiving the medication cemiplimab. This is administered as a solution for infusion, which means it is given through a vein over a period of time.
The specific dosage and frequency of administration are determined by the study protocol and will be explained by the healthcare team. The duration of this treatment phase is designed to evaluate the effectiveness of cemiplimab before surgery.
Step 3
Surgery
After completing the treatment with cemiplimab, surgery is performed to remove the cancerous lesion. The surgical plan may be adjusted based on the response to the treatment.
The goal is to achieve a pathologic complete response, meaning no cancer cells are found in the tissue removed during surgery.
Step 4
Post-surgical follow-up
Following surgery, regular follow-up visits are scheduled to monitor recovery and assess any changes in health status. These visits help in evaluating the long-term effectiveness of the treatment and the overall survival rate.
The follow-up period also includes monitoring for any adverse events or side effects related to the treatment.

Who can join the trial?

6 criteria

You must have **Stage II to IV cutaneous squamous cell carcinoma**. This is a type of skin cancer. For Stage II, the tumor must be at least 3 cm in its longest part.
You must have at least one tumor that can be measured using a standard method called **RECIST 1.1**.
Your **ECOG performance status** must be 0 or 1. This is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work.
Your organs, bone marrow, and liver must be working well enough, as defined in the study's guidelines.
Both **men and women** can participate.
You must be an adult, as the study includes age ranges for adults.

Who cannot join the trial?

7 criteria

Patients with any other type of cancer besides **Stage II to IV cutaneous squamous cell carcinoma** cannot participate.
Patients who have received any other treatment for their cancer that might interfere with the study cannot participate.
Patients with a history of severe allergic reactions to similar drugs cannot participate.
Patients with uncontrolled medical conditions that could affect their safety or the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.
Patients who are participating in another clinical trial cannot participate.

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Verified sites

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Technische Universitaet Dresden
Dresden, Germany
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Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Germany

Trial locations

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Investigated drugs

Cemiplimab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this study, it is used before surgery to treat a type of skin cancer called cutaneous squamous cell carcinoma. The goal is to see if the cancer can be reduced or eliminated before surgery, making it easier to remove and potentially improving the outcome of the treatment.

Cemiplimab

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced stages of cutaneous squamous cell carcinoma, a type of skin cancer. The medication works by blocking a specific protein on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. Cemiplimab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Cutaneous Squamous Cell Carcinoma – Cutaneous squamous cell carcinoma is a type of skin cancer that originates in the squamous cells, which are flat cells located in the outer part of the epidermis. It typically begins as a small, rough, scaly patch on sun-exposed areas of the skin, such as the face, ears, neck, lips, and back of the hands. As the disease progresses, these patches can grow larger, become raised, and develop into a firm, red nodule. Over time, the carcinoma may ulcerate or form a crusty surface. If left untreated, it can invade deeper layers of the skin and spread to other parts of the body. The progression of the disease can vary, with some lesions remaining superficial while others become more aggressive.