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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita Degli Studi Di Brescia	Brescia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	13.05.2021

Trial locations

Investigated drugs:

Cemiplimab

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.

Investigated diseases:

Squamous cell carcinoma of skin

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 ID:

2024-515204-39-00

Protocol code:

NEO-CESQ

NCT ID:

NCT04632433

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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