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Evaluation of Cemiplimab Safety and Effectiveness as First Treatment for Advanced Basal Cell Carcinoma in Adult Patients

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What is this trial about?

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

This clinical trial focuses on treating patients with advanced basal cell carcinoma, a type of skin cancer. The study will evaluate a medication called cemiplimab (also known as LIBTAYO) when used as the first treatment for this condition. This medicine is given as an infusion directly into a vein.

The purpose of this study is to determine how well cemiplimab works and how safe it is when used as the initial treatment for advanced basal cell carcinoma that cannot be treated with surgery or radiation therapy. During the study, participants will receive cemiplimab infusions at a dose of 350 mg every three weeks for up to 51 weeks.

Throughout the treatment period, doctors will monitor participants' response to the medication and check for any side effects. The study will track various aspects of the treatment's effectiveness, including how many patients show improvement, how long the treatment works, and how long patients survive after starting the treatment. Blood samples and tissue samples will be collected to help understand how the medication affects the cancer.

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

    Initial assessment

    Laboratory tests will be performed to check blood count, kidney, and liver function

    For females who can become pregnant, a pregnancy test must be completed within 7 days before starting the study

  2. Step 2

    Tissue sample collection

    A sample of tumor tissue will be sent to central laboratory for confirmation of basal cell carcinoma

    The tissue sample will be examined to understand how the tumor responds to treatment

  3. Step 3

    Treatment administration

    LIBTAYO (cemiplimab) 350 mg will be given through an intravenous infusion

    Treatment will continue for at least 6 months, unless the disease progresses or side effects become too severe

  4. Step 4

    Monitoring during treatment

    Regular assessments will check how the tumor responds to treatment

    Side effects will be monitored and rated according to their severity

    Blood samples will be collected for analysis

  5. Step 5

    6-month evaluation

    After 6 months of treatment, a thorough assessment will determine if the tumor has responded to treatment

    Response can be either complete (tumor disappeared) or partial (tumor shrunk)

  6. Step 6

    Long-term follow-up

    Monitoring will continue to track how long the response to treatment lasts

    Any additional treatments needed after this study will be documented

  7. Step 7

    Safety requirements

    Effective birth control must be used during treatment and for 6 months after the last dose

    This applies to both female patients who can become pregnant and male patients with partners who can become pregnant

Who can join the trial?

13 criteria

  • Must be at least 18 years old
  • Must sign an informed consent form
  • Must have a confirmed diagnosis of basal cell carcinoma verified by central laboratory testing
  • Must have locally advanced cancer that cannot be treated with surgery or radiation, or where these treatments are not recommended or refused
  • Must have a life expectancy of at least 6 months
  • Must have good physical performance status (ECOG score of 0 or 1, meaning able to carry out light daily activities)
  • Must have adequate blood test results, including:
    • Sufficient white blood cells, red blood cells, and platelets
    • Normal liver function tests
    • Acceptable kidney function
    • Women who can become pregnant must have a negative pregnancy test within 7 days before starting the study
    • Both men and women who can have children must use effective birth control during treatment and for 6 months after the last dose
    • Must not have other serious health conditions
    • Must have recovered from any side effects of previous treatments (except hair loss) before starting the study

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Previous treatment with Hedgehog pathway inhibitors (HHI) - medications that target specific cellular pathways in cancer treatment
  • Currently receiving other cancer treatments
  • Presence of active autoimmune disease - conditions where the immune system attacks healthy cells
  • History of organ transplant
  • Untreated brain or spinal cord metastases - cancer that has spread to these areas
  • Active infection requiring systemic therapy - infections needing medication that affects the whole body
  • Known HIV, active hepatitis B, or hepatitis C infection
  • History of other malignancies within 5 years - other types of cancer in the past 5 years
  • Pregnant or breastfeeding women
  • Serious heart conditions or uncontrolled high blood pressure
  • Known allergies to study medication components
  • Participation in other clinical trials within 30 days before this study
  • Mental conditions that could interfere with study compliance
  • Life expectancy less than 3 months
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Investigated drugs

Cemiplimab is a type of immunotherapy medication that helps your immune system fight against cancer cells. It works by targeting and blocking a protein called PD-1, which allows your body's immune cells to better recognize and attack cancer cells. This medication is specifically being studied for treating advanced basal cell carcinoma (a type of skin cancer) in patients who haven't received previous treatment with hedgehog pathway inhibitors. The medication is given through an intravenous infusion (through a vein).

What is already known about the treatment

Cemiplimab - A monoclonal antibody medication administered through intravenous infusion, primarily used in the treatment of advanced basal cell carcinoma (BCC) as a first-line therapy. This immunotherapy drug belongs to the class of PD-1 inhibitors, working by blocking the PD-1 protein on T cells, which helps the immune system recognize and attack cancer cells more effectively. Cemiplimab represents a significant advancement in targeted cancer therapy, particularly for patients with advanced skin cancers who haven't previously received hedgehog pathway inhibitor (HHI) treatment, and its efficacy is measured through objective response rate after several months of treatment.

Investigated diseases

Basal Cell Carcinoma - A type of skin cancer that begins in the basal cells, which produce new skin cells as old ones die off. It typically develops on sun-exposed areas of skin, appearing as a waxy bump, flesh-colored lesion, or scaly patch. This cancer usually grows slowly and tends to stay in one place without spreading to other parts of the body. The condition commonly starts as a painless raised area of skin that may be shiny with small blood vessels running over it. Over time, the lesion may bleed, develop a crust, heal, and then begin bleeding again.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517647-31-00Protocol codeCEMI-firstEstimated enrolment34 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

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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).