AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT

Cutaneous squamous cell carcinoma is a common type of skin cancer. Usually, the main treatment is surgery to remove the tumour. However, when cancer is in delicate areas such as the face, nose, or ears, surgery can cause significant scarring or change how the area looks and works. This trial is looking at an immunotherapy drug called Libtayo (cemiplimab). Immunotherapy helps your own immune system fight cancer cells. Researchers want to find out if receiving Libtayo can shrink or clear the cancer so that surgery is no longer needed. Participants will receive the medicine as a drip into a vein and will have regular scans and check-ups to track their progress. The main goal is to measure how many people remain surgery-free after one year, while also checking their quality of life and general well-being.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione GONO Plus

Enrolment target

Start

14 Jul 2026

cutaneous squamous cell carcinoma

What is this study about?

Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer in the UK. For most people, standard treatment involves an operation to cut out the cancer along with a border of healthy skin. While surgery often cures the cancer, it can be challenging if the tumour is large or located on sensitive areas such as the eyelids, nose, lips, or ears. In these spots, surgery can cause noticeable scarring or affect everyday functions.

This clinical study, called INCEPT, is testing an approach known as 'organ preservation'. Instead of operating straight away, doctors give patients an immunotherapy drug called Libtayo (cemiplimab). Immunotherapy works by boosting your body's natural defences so that your immune cells can recognise and attack cancer cells. The goal is to shrink or completely clear the tumour without needing an operation.

During the trial, doctors will use non-invasive scans and tests to closely monitor how the cancer responds. If the medicine works well, patients may be able to skip surgery entirely. Researchers want to see what percentage of patients can safely avoid surgery for at least one year.

This study matters because avoiding major surgery could mean less scarring, fewer surgical risks, and a better quality of life. The findings will also help doctors understand how to tailor skin cancer treatments more closely to each person's individual needs.

Key takeaways

Tests an immunotherapy drug called Libtayo for cutaneous squamous cell carcinoma.
Aims to shrink the tumour so patients can safely avoid surgery and reduce scarring.
Open to adults aged 18 and older with this specific type of skin cancer.
Involves regular hospital visits for drug infusions, scans, and health questionnaires.
Doctors will monitor your progress closely for at least one year.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with cutaneous squamous cell carcinoma. It is designed for both men and women whose cancer may benefit from immunotherapy before deciding whether surgery is needed.

To take part, your medical team will check that you are well enough to receive immunotherapy. People with certain serious health conditions, such as severe autoimmune diseases or active, uncontrolled infections, may not be able to join because immunotherapy can sometimes make these conditions worse.

Your hospital doctor or cancer specialist can review your medical records, check your overall health, and tell you if this trial is a safe and suitable option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with cutaneous squamous cell carcinoma (skin cancer).
I am considering treatment options and want to know if surgery can be avoided.
I am well enough to attend regular outpatient hospital visits.
I do not have an active, severe autoimmune disease that prevents immunotherapy.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive Libtayo as a liquid infusion (a slow drip into a vein in your arm). These hospital visits take place on a regular schedule over several months. During each visit, the nursing team will check your blood pressure, temperature, and general health before you receive the treatment.

You will have routine blood tests and gentle, non-invasive imaging scans to track how your skin and tumour are responding. You will also be asked to complete short questionnaires about how you are feeling, any symptoms you have, and your thoughts about your treatment journey.

Doctors will follow your health for at least one year to check whether you have needed surgery and to ensure you remain well. If at any point the tumour grows or does not respond, your care team will discuss other proven treatments with you, including surgery.

Potential risks and benefits

The possible benefit of taking part is that the treatment may shrink your skin cancer and allow you to avoid major surgery, which could reduce scarring and recovery time. However, there is no guarantee that the treatment will work for everyone. Like all medicines, Libtayo can cause side effects. Common ones include tiredness, rash, diarrhoea, or mild flu-like symptoms. Because it stimulates the immune system, it can occasionally cause inflammation in healthy organs like the lungs, liver, or bowel. Your safety will be closely monitored throughout the study. Taking part is entirely voluntary, and you can withdraw at any time without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your own immune system recognise, target, and destroy cancer cells.

Will I definitely be able to avoid surgery?

Not necessarily. The aim is to avoid surgery if the drug clears or shrinks the tumour sufficiently, but surgery remains an option if the cancer does not respond.

How is the medicine given?

Libtayo is given as a drip directly into a vein, usually taking around 30 minutes during an outpatient hospital visit.

Can I leave the trial if I change my mind?

Yes. You are free to leave the trial at any point, and your doctors will continue to provide you with the best available standard care.

Will taking part in this trial cost me anything?

No. The study drug and all trial-related tests are provided free of charge, and some hospitals may help with travel expenses.