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A study of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on cutaneous squamous cell carcinoma, which is a type of skin cancer that develops from the squamous cells in the outer layer of the skin. The research investigates why some patients may not respond to certain types of treatments, a process known as resistance. The study will use a drug called cemiplimab, which is administered through an intravenous infusion, a method where medicine is delivered directly into a vein. The purpose of the study is to understand how the immune environment and changes in tumor cells affect the effectiveness of this medication.

During the study, participants will receive the medication to observe how the skin cancer reacts. Researchers will examine blood and tumor samples to look for biomarkers, which are biological signs that can indicate how a person might respond to a treatment. They will also study how myeloid suppressor cells, which are specific immune cells that can prevent the body from attacking cancer, move into the tumor area. This information helps in understanding the biological changes that happen within the cancer cells during therapy.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    The treatment involves receiving cemiplimab, which is a type of medication used to help the immune system fight cancer. this is provided as a 350 mg concentrate for solution for infusion.

    The medication is administered through an intravenous infusion, which means it is delivered directly into a vein.

  2. Step 2

    Sample collection and analysis

    During the study, blood and tumor samples are collected. these samples are used to study how the body responds to the treatment.

    The samples undergo various tests, such as genomic and pathological analysis, to look at the characteristics of the cells and the immune environment.

  3. Step 3

    Monitoring progress

    The effectiveness of the treatment is monitored by measuring progression-free survival, which is the length of time during and after treatment that the disease does not get worse.

    The overall response rate is also measured to determine how many people see a reduction in the size or extent of their cancer.

Who can join the trial?

10 criteria

  • Both men and women who are 18 years of age or older can participate.
  • Participants must provide written informed consent, which means they must sign a document agreeing to take part in the study after understanding all the details.
  • Patients must have locally advanced cutaneous squamous cell carcinoma, which is a type of skin cancer that has grown into the nearby area but has not spread to distant parts of the body.
  • The skin cancer must be large enough to allow doctors to collect tumor tissue for biological testing.
  • Patients must not have received any systemic treatment, which is medicine that travels through the whole body, for their skin cancer before starting this study.
  • Participants must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well a patient can perform daily activities and their overall physical health.
  • Patients must have adequate organ and bone marrow function, meaning their liver, kidneys, blood-making cells in the bones, and levels of a specific muscle enzyme called creatine phosphokinase (CPK) must be within healthy ranges.
  • The expected life expectancy must be more than 12 weeks.
  • Men must agree to use highly effective birth control during the study and for 4 months after the last treatment.
  • Women who are able to become pregnant must have a negative pregnancy test and agree to use highly effective birth control during the study and for 6 months after the last treatment.

Who cannot join the trial?

19 criteria

  • Having cancer that has spread to the brain (metastasis) that is not currently being treated.
  • Having an active or uncontrolled infection, such as HIV, hepatitis B, hepatitis C, or tuberculosis (an infection that can be active or lying dormant in the body).
  • Having a diagnosis of immunodeficiency (a condition where the body's immune system is too weak to fight off infections).
  • Having pneumonitis (inflammation of the lung tissue) at any time in the last 5 years.
  • Having received a live vaccine (a type of vaccine that uses a weakened form of a germ) within 4 weeks before starting the study medication.
  • Having received a COVID-19 vaccination within 1 week before starting the study, or if the vaccination will not be completed at least 1 week before starting.
  • Having a known hypersensitivity (an extreme allergic reaction) to the study medication or any of its excipients (inactive ingredients used to make the medicine).
  • Women who can become pregnant, or sexually active men, who are not willing to use highly effective contraception (methods used to prevent pregnancy, such as birth control) before, during, and for at least 6 months after the study.
  • Being pregnant or having a positive pregnancy test.
  • Currently breastfeeding.
  • Having a second type of cancer (secondary malignancy) that is growing or has been treated within the last 2 years.
  • Having any medical or psychiatric (mental health) condition that the doctor believes makes taking the medication unsafe or prevents the person from following the study rules.
  • Having received any anticancer treatment (such as chemotherapy or targeted therapy) within 30 days of the study, or planning to receive such treatment during the study, except for radiation therapy.
  • Having certain cardiovascular diseases (heart and blood vessel problems), such as heart failure (when the heart cannot pump enough blood), a recent myocardial infarction (heart attack), acute coronary syndrome (a sudden reduction of blood flow to the heart), or having had a stroke or transient ischemic attack (a temporary blockage of blood flow to the brain) within the last year.
  • Having a history of solid organ transplants (receiving an organ from another person), though some people with previous eye transplants may be allowed.
  • Having a history of allergic reactions specifically caused by antibody treatments (medicines made to target specific parts of the immune system).
  • Needing continuous corticosteroid therapy (strong anti-inflammatory medicines like prednisone) at a high dose for more than one week before the study starts.
  • Having a significant autoimmune disease (a condition where the immune system attacks the body's own healthy cells) within the last 5 years that required immunosuppressive treatments (medicines that lower the immune system's activity).
  • Having any infection that required hospitalization or IV anti-infectives (medicine given directly into a vein to fight infection) within 2 weeks before the first dose.
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Investigated drugs

Cemiplimab is an immunotherapy drug used to help the body's immune system recognize and fight cancer cells. It works by blocking a specific protein that cancer cells use to hide from the immune system, allowing the body's natural defenses to attack the tumor.

What is already known about the treatment

Cemiplimab - This medication is an immunotherapy administered through an intravenous infusion, where it is delivered directly into a vein. Currently used in clinical practice, it is primarily indicated for treating patients with cutaneous squamous cell carcinoma, a type of skin cancer. It works as a programmed death-1 (PD-1) inhibitor, a type of drug that helps the body's immune system recognize and attack cancer cells by blocking a specific protein that cancer cells use to hide from immune detection.

Investigated diseases

Cutaneous squamous cell carcinoma - This is a type of skin cancer that develops in the squamous cells found in the outer layers of the skin. It typically begins as a small growth or a sore that does not heal. Over time, these abnormal cells can grow deeper into the skin layers. The disease can spread if the cells move from the original site to other parts of the body. It is often linked to long-term exposure to ultraviolet radiation from the sun.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524255-32-00Protocol codeCEMIRESISTEstimated enrolment15 patientsSponsorFundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

sourced from the EU Clinical Trials Register and site verification

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