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Study on Balstilimab for Patients with Advanced Non-Melanoma Skin Cancers

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What is this trial about?

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

This clinical trial is focused on studying advanced forms of non-melanoma skin cancers, which include types like basal cell carcinoma and squamous cell carcinoma. These are skin cancers that have either spread to other parts of the body or cannot be treated with local therapies like surgery or radiation. The treatment being tested in this study is called Balstilimab, which is given as a solution through an infusion into the veins. The purpose of the study is to see if Balstilimab, when used alone, can help activate the immune system to provide clinical benefits to patients with these advanced skin cancers.

Participants in the study will receive Balstilimab and will be monitored over a period of time to assess the safety and effectiveness of the treatment. The study will look at how well the cancer responds to the treatment, whether it remains stable, shrinks, or disappears. The study will also track how long any positive effects last and monitor any side effects that may occur. Patients will have regular check-ups and tests to see how the treatment is affecting their health and the cancer.

The study aims to gather information on the overall survival rates of patients at 12 and 24 months after starting the treatment. It will also collect data on any changes in patients' quality of life and general health. This information will help researchers understand if Balstilimab can be a beneficial treatment option for people with advanced non-melanoma skin cancers.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted. This includes a review of your medical history and a physical examination to ensure you meet the study criteria.

    Blood tests will be performed to check your white blood cell count, hemoglobin levels, and other important health indicators. Your liver and kidney functions will also be assessed.

  2. Step 2

    Tumor biopsy

    A fresh tumor biopsy will be required. This involves taking a small sample of your tumor tissue to confirm the type of skin cancer and its characteristics.

  3. Step 3

    Treatment administration

    You will receive the medication balstilimab as a solution for infusion. This means the medication will be given to you through a vein, a process known as intravenous use.

    The dosage and frequency of administration will be determined by the study team based on your specific condition and response to the treatment.

  4. Step 4

    Regular monitoring

    Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes physical examinations, blood tests, and imaging studies to measure the size of your tumor.

    You will be asked to report any side effects or changes in your health to the study team.

  5. Step 5

    Patient-reported outcomes

    You will be asked to complete questionnaires about your quality of life and any symptoms you experience. These are known as patient-reported outcomes and help the study team understand the impact of the treatment on your daily life.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation will be conducted. This includes a final physical examination, blood tests, and imaging studies to assess the overall effect of the treatment on your cancer.

    If you are over 65 years old, a comprehensive geriatric assessment will also be performed to evaluate your overall health and well-being.

Who can join the trial?

16 criteria

  • Must provide a signed written informed consent, which means you agree to participate after understanding the study.
  • Must have adequate blood and organ function, which includes:
    • White blood count (WBC) greater than 3000/µl.
    • Absolute Neutrophil Count (ANC) greater than 1500/µl.
    • Hemoglobin (Hb) greater than 8 g/dl (or greater than 5.6 mmol/L), and you may have received a blood transfusion up to 7 days before starting the study.
    • Platelet count greater than 100,000/µl.
    • Adequate liver function with serum total bilirubin less than 2 times the upper limit of normal (ULN), and ALT and/or AST less than 3 times ULN (or less than 5 times ULN if you have liver metastases).
    • Adequate kidney function with serum creatinine less than 1.5 times ULN or estimated glomerular filtration rate (eGFR) greater than 40 mL/min.
    • Must use highly effective contraception if there is a risk of pregnancy, for both male and female participants.
    • Must be a male or female aged over 18 years.
    • Must have a confirmed diagnosis of any type of non-melanoma skin cancer, except for cutaneous lymphomas.
    • Must have cancer that has spread or come back locally, with at least one measurable or targetable lesion on the skin or under the skin.
    • Must be unable to have surgery, radiotherapy, or other local treatments due to the progression or extent of the tumor, or have progressed on systemic treatment.
    • Must be able to provide a fresh tumor biopsy.
    • Must have an ECOG Performance Status of 0-2, which is a scale to assess how the disease affects daily living abilities.
    • Must have an estimated life expectancy of more than 12 weeks.
    • The disease must be measurable with at least one lesion that can be measured in one dimension, according to RECIST v1.1 guidelines, including skin lesions.

Who cannot join the trial?

5 criteria

  • Patients who have a type of skin cancer that can be treated with local therapy cannot participate.
  • Patients who have not tried at least one type of systemic therapy (treatment that affects the entire body) for their advanced basal cell carcinoma cannot participate.
  • Patients with other types of skin cancer that can be treated with local therapy cannot participate.
  • Patients who are not able to understand or follow the study procedures cannot participate.
  • Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate cannot participate.
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Investigated drugs

Balstilimab is a medication being studied for its potential to help the body's immune system fight against certain types of skin cancer. It works by activating immune cells, which are the body's natural defense against diseases, to improve the treatment outcomes for patients with advanced or metastatic non-melanoma skin cancers. This includes types of skin cancer like squamous cell carcinoma, basal cell carcinoma, Merkel cell carcinoma, Kaposi sarcoma, angiosarcoma, and other non-melanoma skin cancer subtypes. The goal of using balstilimab is to see if it can provide clinical benefits to patients whose cancer cannot be removed by surgery.

What is already known about the treatment

Balstilimab – Balstilimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its potential use in treating advanced or metastatic non-melanoma skin cancers, such as advanced basal cell carcinoma and squamous cell carcinoma, which cannot be treated with local therapies. The main therapeutic indication for balstilimab is to improve clinical outcomes in patients with these types of skin cancers. At the molecular level, balstilimab works by activating immune cells to help the body fight cancer cells more effectively. It is classified as an immunotherapy drug, which means it helps the immune system recognize and attack cancer cells.

Investigated diseases

  • Advanced Basal Cell Carcinoma

    This is a type of skin cancer that begins in the basal cells, which are found in the outer layer of the skin. It typically appears as a slightly transparent bump on the skin, though it can take other forms. As it progresses, it can grow deeper into the skin and nearby tissues. It is considered advanced when it cannot be treated with local therapies or has progressed after systemic treatment. The disease may cause changes in skin appearance, such as open sores, red patches, or shiny bumps. It can also lead to discomfort or pain in the affected area.

  • Advanced Squamous Cell Carcinoma

    This is a form of skin cancer that originates in the squamous cells, which make up the middle and outer layers of the skin. It often presents as a firm, red nodule or a flat lesion with a scaly, crusted surface. As it advances, it can invade deeper layers of the skin and spread to other parts of the body. The disease is considered advanced when it cannot be managed with local treatments. It may cause skin changes, including persistent, non-healing sores or growths. The affected area might become painful or tender.

  • Merkel Cell Carcinoma

    This is a rare and aggressive type of skin cancer that starts in the Merkel cells, which are found at the base of the outermost layer of the skin. It usually appears as a painless, flesh-colored or bluish-red nodule on the skin, often on the face, head, or neck. As it progresses, it can grow rapidly and spread to other parts of the body. The disease can cause noticeable changes in the skin, such as new growths or changes in existing moles. It may also lead to swelling or discomfort in the affected area.

  • Kaposi Sarcoma

    This is a cancer that develops from the cells that line lymph or blood vessels. It typically presents as purple, red, or brown patches or nodules on the skin or mucous membranes. As it progresses, it can affect internal organs and lead to swelling and pain. The disease is associated with a weakened immune system and can spread to other parts of the body. It may cause skin lesions that are flat or raised and can vary in size. The affected areas might become swollen or painful.

  • Angiosarcoma

    This is a rare cancer that arises from the cells that line blood vessels or lymph vessels. It often appears as a bruise-like lesion on the skin, which can grow and change color over time. As it progresses, it can invade surrounding tissues and spread to other parts of the body. The disease can cause skin changes, such as new or enlarging lesions that may bleed or become ulcerated. It may also lead to swelling or discomfort in the affected area. The condition is known for its aggressive nature and rapid growth.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517380-22-00Protocol codeAGENONMELAEstimated enrolment39 patientsSponsorNarodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

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