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Study of Cemiplimab Combined with Imiquimod and Laser Therapy Before Surgery for High-Risk Skin Basal Cell Carcinoma

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What is this trial about?

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

This study investigates the treatment of cutaneous basal cell carcinoma, a type of skin cancer, using a combination therapy approach. The treatment being tested involves cemiplimab (given intravenously), imiquimod (applied topically to the skin), and laser therapy as a treatment before surgery. This is called a neoadjuvant treatment, which means it is given before the main treatment (in this case, surgery) to potentially reduce the size of the tumor.

The purpose of this study is to evaluate both the safety and effectiveness of this combination therapy in patients with high-risk basal cell carcinoma that could potentially be removed by surgery. The study is conducted in two parts: Phase Ib focuses on safety and side effects, while Phase II examines how well the treatment works at preventing cancer from returning after surgery.

Participants in this study will receive the combination treatment before undergoing surgical removal of their tumor. Throughout the study, doctors will monitor patients for side effects and assess how the tumor responds to treatment. They will also track whether the cancer returns over a three-year period following treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Eligibility confirmation

    You will be confirmed eligible for this trial if you have basal cell carcinoma (BCC) that is potentially resectable (can be removed with surgery) and considered high risk due to size, location, or type.

    Your doctor will check that you meet all requirements including being at least 18 years old, having adequate organ function, and following contraception requirements if applicable.

  2. Step 2

    Tissue sample collection

    A sample of your tumor tissue will be collected before treatment starts, unless your doctor determines this would be unsafe.

    If a new biopsy cannot be taken, tissue from a previous biopsy may be used instead.

  3. Step 3

    Treatment phase - Phase Ib

    You will receive a combination treatment that includes:

    Cemiplimab (LIBTAYO) - given as an intravenous (IV) infusion at a dose of 350 mg

    Imiquimod (IMUNOCARE 5% cream) - applied directly to the skin tumor

    Fractional laser therapy - applied to the tumor area

  4. Step 4

    Treatment phase - Phase II

    If you continue to Phase II, you will receive either:

    Cemiplimab alone as intravenous therapy

    OR

    Combination of cemiplimab, imiquimod cream, and fractional laser therapy as in Phase Ib

  5. Step 5

    Surgery

    After completing the treatment course, you will undergo surgery to remove any remaining tumor.

    The tissue removed during surgery will be examined to determine if any cancer cells remain.

  6. Step 6

    Follow-up assessments

    You will have regular follow-up visits for 3 years after starting treatment.

    During these visits, your doctor will check for any signs of cancer recurrence or progression.

    Your overall health and any side effects from treatment will be monitored.

  7. Step 7

    Long-term monitoring

    The study will track your relapse-free survival (time without cancer returning) for 3 years.

    The study will also monitor your overall survival and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • You must be at least 18 years old
  • You must have a confirmed diagnosis of basal cell carcinoma (a type of skin cancer) that can potentially be removed with surgery
  • Your cancer must be considered "high risk," meaning:
    • It's large (at least 2 cm wide on the trunk/extremities or any size on head, neck, hands, feet, shin area, or genital region) and could cause cosmetic or functional problems if surgically removed
    • OR it has certain aggressive features (like basosquamous, infiltrative, sclerosing/morpheaform, micronodular patterns)
    • OR it's a recurrent large tumor (at least 3 cm in medium-risk areas or 5 cm on trunk/extremities)
    • OR you have multiple tumors that would cause cosmetic or functional problems if removed
    • You must have at least one measurable lesion
    • Your ECOG performance status (a measure of your ability to perform daily activities) must be 0 or 1 (able to care for yourself with minimal or no assistance)
    • You must have a life expectancy of at least 24 weeks
    • A tumor tissue sample must be available from before treatment starts
    • You must have adequate organ and bone marrow function based on blood tests
    • If you're a woman who can become pregnant, you must have a negative pregnancy test and use highly effective birth control during the study and for 180 days after the last dose of treatment
    • If you're a man who can father children, you must agree to use contraception and not donate sperm during the study and for 180 days after the last dose of treatment

Who cannot join the trial?

12 criteria

  • You have had treatment for your skin cancer (basal cell carcinoma) in the last 6 months, including surgery, radiation, or other therapies.
  • You currently have or have had a different type of skin cancer.
  • You have a skin cancer that has spread to other parts of your body (metastatic disease).
  • You are currently participating in another clinical trial.
  • You have a medical condition that weakens your immune system, such as HIV/AIDS or an autoimmune disease.
  • You are taking medications that suppress your immune system, such as steroids.
  • You have had an organ transplant and are on anti-rejection medications.
  • You are pregnant or breastfeeding.
  • You have a history of allergic reactions to similar treatments used in this study.
  • You have severe heart, liver, or kidney disease that could make study participation unsafe.
  • You have an active infection requiring treatment.
  • You cannot comply with the study requirements, including follow-up visits.
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Investigated drugs

  • Cemiplimab

    is a type of immunotherapy drug that helps your immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which normally helps cancer cells hide from your immune system. It is given intravenously (through a vein).

  • Imiquimod

    is a cream that is applied directly to the skin (topical). It works by stimulating your immune system to fight cancer cells in the skin. It helps your body produce substances that fight viruses and cancer cells.

  • Fractional laser therapy

    is a treatment that uses laser light to create tiny wounds in the skin. This process triggers the body's natural healing response and may help other treatments penetrate deeper into the skin, potentially making them more effective against skin cancer.

What is already known about the treatment

  • Cemiplimab

    A medication administered intravenously that works as a programmed death receptor-1 (PD-1) inhibitor, blocking the interaction between PD-1 and its ligands to enhance T-cell immune responses against cancer cells. It is FDA-approved for treating advanced cutaneous squamous cell carcinoma and basal cell carcinoma, with clinical trials exploring its use as neoadjuvant therapy for high-risk, resectable basal cell carcinoma. Cemiplimab belongs to the class of immune checkpoint inhibitors and works by preventing cancer cells from evading the immune system's surveillance.

  • Imiquimod

    A topically applied medication that functions as an immune response modifier, stimulating the production of cytokines and enhancing the body's immune response against abnormal skin cells. It is currently approved for treating external genital warts, actinic keratosis, and superficial basal cell carcinoma, with ongoing research into its combined use with other therapies for more advanced forms of skin cancer. Imiquimod works by activating toll-like receptor 7, triggering a local inflammatory response that helps eliminate cancerous or precancerous cells.

Investigated diseases

Cutaneous Basal Cell Carcinoma – A common type of skin cancer that begins in the basal cells, which are cells within the skin that produce new skin cells as old ones die. It often appears as a waxy bump, flesh-colored lesion, or scaly patch on sun-exposed areas of the skin. This cancer typically develops on areas exposed to the sun, such as the face and neck. Cutaneous basal cell carcinoma usually grows slowly and rarely spreads to other parts of the body. It may start as a small, shiny bump that grows over time and sometimes develops tiny blood vessels on the surface. The cancer can cause local tissue destruction if left untreated, potentially invading nearby tissues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-520698-38-00Protocol codeIOR-REG-2501Estimated enrolment18 patientsSponsorInstituto Oncologico Dr. Rosell S.L.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).