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Phase II Study of Cemiplimab to Spare Surgery in Patients with Locally Advanced 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

The study focuses on patients with cutaneous squamous cell carcinoma, a type of skin cancer that can grow deep into the skin and surrounding tissues. The treatment being tested is cemiplimab, a medicine that works as immunotherapy to help the body’s own immune system attack cancer cells. The drug is given by an infusion, meaning it is administered slowly through a vein in the arm.

The purpose of the study is to see whether giving this medication early can reduce the need for local treatments such as surgery. Participants receive the medication at regular intervals over several months and are then followed with regular check‑ups, imaging scans, and simple skin examinations to determine if the cancer can be controlled without removing tissue.

Researchers will record how many people avoid surgery after one year, how long they remain free of cancer growth or return, and overall survival. They will also monitor side effects and how patients feel about their treatment decisions, using questionnaires and occasional biopsies when needed.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
After joining the study, you will undergo a series of initial examinations to confirm the diagnosis of cutaneous squamous cell carcinoma and to record your overall health status.
These examinations may include a physical check, imaging tests that do not require surgery, and a tissue sample (biopsy) to evaluate the tumor.
Step 2
First cemiplimab infusion
The study treatment begins with an intravenous infusion of cemiplimab at a dose of 350 mg. intravenous infusion means the medication is delivered directly into a vein.
The infusion is prepared from a concentrate for solution for infusion and is administered in a clinical setting under medical supervision.
Step 3
Repeated cemiplimab treatment cycles
You will receive additional infusions of the same 350 mg dose of cemiplimab according to the study schedule. each infusion follows the same procedure as the first one.
The exact timing of each infusion is defined by the trial protocol and is intended to maintain consistent drug exposure over the treatment period.
Step 4
Regular monitoring and response evaluation
Throughout the treatment period, you will attend scheduled visits for non‑invasive response evaluation, which may include imaging that does not require surgery.
These visits help determine how the tumor is responding to the medication and whether any side effects are occurring.
Step 5
Assessment of need for surgery at one year
Approximately one year after the start of treatment, the study will assess whether surgery is still required. the primary goal is to identify patients who can avoid surgery because the tumor has responded sufficiently to the medication.
Step 6
Post‑treatment follow‑up
Three months after the final infusion, you will have a follow‑up visit to evaluate any remaining disease and to record your health status.
Additional follow‑up continues for at least one year to monitor for relapse, overall survival, and any long‑term effects of the treatment.

Who can join the trial?

11 criteria

Age: You must be 18 years old or older (or the legal adult age in your country) on the day you sign the consent form.
Birth control: If you can have children, you need to use an effective method of contraception (such as hormonal pills, condoms, or choose not to have sex) before joining the study and while you are in it.
Organ health: Your blood tests must show that your bone‑marrow, liver, kidneys and blood clotting are working well. This means a white‑blood‑cell count (absolute neutrophil count) of at least 1.5 × 10⁹/L, hemoglobin of 9 g/dL or higher, platelets of 100 × 10⁹/L or more, liver enzymes ALT and AST no more than 2.5 times the normal limit, total bilirubin no more than 1.5 times normal (higher limits are allowed if you have Gilbert’s syndrome), creatinine no more than 1.5 times normal or a calculated kidney clearance of at least 60 mL/min, albumin of 3 g/dL or higher, clotting tests (INR, PT, APTT/PTT) within 1.5 times normal unless you are on stable blood‑thinning medication, and normal levels of electrolytes such as magnesium, sodium, calcium, phosphate and potassium (or corrected with supplements).
Signed consent: You must sign and date the study’s informed consent form that has been approved by an ethics committee.
Confirmed diagnosis: A tissue sample must have verified that you have cutaneous squamous cell carcinoma (a type of skin cancer).
Stage of cancer: Your cancer must be classified as stage II (tumor at least 3 cm), stage III, or stage IV without distant spread (M0) according to the AJCC 8th edition staging system.
Team review: A group of specialists (ear‑nose‑throat surgeon, general or plastic surgeon, radiation oncologist, and medical oncologist) must review your case and agree that surgery would likely leave cancer behind or cause major disfigurement, that radiation therapy would have a low chance of success or a high risk of serious side effects, and that you are suitable for treatment with the drug cemiplimab as described in its official prescribing information.
Refusal of other treatments: You must have chosen not to have surgery or definitive radiotherapy for your cancer.
Performance status: Your ability to carry out daily activities must be rated as 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, meaning you are fully active or able to do light work.
Measurable disease: Your tumor must be measurable on imaging tests according to iPERCIST criteria (a set of rules that define how tumor size is measured on scans).
Pregnancy precautions: If you are a woman who could become pregnant, you must have a negative pregnancy test at screening and must not be breastfeeding.

Who cannot join the trial?

13 criteria

Had radiotherapy (radiation treatment) for skin squamous cell cancer in the same area before.
Taking medicines that suppress the immune system (immunosuppressive drugs) except low‑dose steroids like prednisone 10 mg daily.
Have an autoimmune disease (a condition where the body attacks itself); if you have limited skin psoriasis, doctors will decide if you can be included.
Have active tuberculosis (TB), a bacterial infection that usually affects the lungs.
Are currently enrolled in, or taking part in, another therapeutic clinical trial.
Have received an organ transplant (such as a kidney, liver, or heart).
Have received a bone‑marrow transplant, a procedure that replaces blood‑forming cells.
Received a live vaccine within 30 days before starting the study (live vaccines contain weakened germs that can cause disease in some people). Note: regular injected flu shots are allowed, but nasal flu spray is not.
Have cancer that has spread to other parts of the body (metastatic disease, stage M1).
Have a heart, lung, infection, nerve, or any other medical condition that the doctor thinks could interfere with treatment (cardiac, pulmonary, neurological disease).
Had another type of cancer diagnosed in the past three years (except for very early cervical cancer or skin cancers that were completely removed).
Have a primary immune deficiency, known HIV infection, or active HBV or HCV infection (hepatitis B or C).
Have a serious mental health problem (psychiatric disorder), known substance abuse issue, or are under legal restriction (for example, jailed).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Azienda Ospedaliero Universitaria Di Modena
Verified
Modena, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

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Investigated drugs

LIBTAYO is an immunotherapy medicine that contains the active ingredient cemiplimab. It is given through an IV infusion. The drug helps the body’s immune system find and attack cancer cells, aiming to shrink or eliminate difficult‑to‑treat skin cancer. In this study, patients receive LIBTAYO first, hoping it will reduce the tumor enough so that surgery or other local treatments may not be needed.

The trial also uses a non‑invasive response evaluation. This means doctors watch how the tumor changes without doing surgery, using imaging scans, photographs, and other visual checks. By seeing the tumor’s response early, they can decide whether the immunotherapy is working and if surgery can be avoided.

Cemiplimab

What is already known about the treatment

LIBTAYO 350 mg concentrate for solution for infusion - This medication is given by slow intravenous infusion, where the concentrate is mixed with a fluid bag and delivered through a vein. Cemiplimab is an approved drug that is well‑studied in the medical literature and is available for use in cancer treatment. It is primarily used for advanced cutaneous squamous cell carcinoma and similar skin cancers. The drug works by attaching to the PD‑1 protein on immune cells, blocking its interaction with PD‑L1/PD‑L2, which releases the immune system’s brake and allows it to attack tumor cells; it belongs to the class of immune checkpoint inhibitors.

Investigated diseases

Cutaneous squamous cell carcinoma - Cutaneous squamous cell carcinoma is a type of skin cancer that starts in the flat cells on the outer layer of the skin. It usually appears as a rough, scaly patch or a raised growth that may crust or bleed. Over time the growth can become larger and can spread deeper into the skin and nearby tissues. In some cases it can extend beyond the skin to surrounding areas, continuing to grow if not removed.