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Study of L19IL2 and L19TNF for Patients with Advanced Basal Cell Carcinoma or Cutaneous Squamous Cell Carcinoma Not Eligible for Surgery or Radiation

Verified siteInvestigationalNo placebo
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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 treatments for two types of skin cancer: Basal Cell Carcinoma (BCC) and cutaneous Squamous Cell Carcinoma (cSCC). These are forms of non-melanoma skin cancer, which means they are not the more aggressive melanoma type. The study involves two medications, Fibromun and Darleukin, which are given as a solution for injection directly into the tumor. The active substances in these medications are called onfekafusp alfa and bifikafusp alfa, respectively.

The purpose of the study is to evaluate how well these treatments work in shrinking or eliminating the tumors. Participants in the study will receive either the active treatment or a placebo. The study will last for a period of up to four months, during which the medications will be administered directly into the tumor. The effectiveness of the treatment will be assessed by looking at the overall response of the tumors, which includes both complete disappearance and partial reduction in size.

Throughout the study, the safety of the treatments will also be monitored. This means that any side effects or reactions to the medications will be carefully observed and recorded. The goal is to determine not only how effective the treatments are but also how safe they are for patients with these types of skin cancer. Participants will be required to attend regular visits for treatment and monitoring during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and type of skin cancer.

    A negative pregnancy test is required for women of childbearing potential, and effective contraception must be used during the study and for three months after the last dose.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the skin cancer and determine the suitability for intratumoral injection.

    This includes a histological evaluation to confirm the diagnosis and stage of the cancer.

  3. Step 3

    Treatment administration

    The treatment involves the intratumoral administration of two medications: Fibromun and Darleukin, both in the form of a solution for injection or infusion.

    These medications are administered directly into the tumor, following a schedule determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment, including measuring the size of the tumor and checking for any side effects.

    Follow-up visits are scheduled to evaluate the overall response rate and ensure the safety of the treatment.

  5. Step 5

    Completion of the study

    The study is expected to continue until December 31, 2025, with ongoing assessments to determine the efficacy and safety of the treatment.

    Upon completion, a final evaluation is conducted to confirm the best overall response rate and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Patients must have a type of skin cancer called Basal Cell Carcinoma (BCC) or cutaneous Squamous Cell Carcinoma (cSCC) that is advanced but has not spread to other parts of the body. The cancer should be suitable for a treatment that involves injecting directly into the tumor.
  • Patients should not be eligible for surgery or radiation therapy, or they must have refused these treatments. A detailed examination of the cancer cells must be available.
  • Patients with cancer that can be measured and injected, but without involvement of nearby lymph nodes, are also eligible.
  • Patients can be male or female and must be between 18 and 100 years old.
  • Patients must have a good general health status, as measured by a scale called ECOG Performance Status, which should be 0 or 1. This means they should be fully active or have some symptoms but do not need to stay in bed.
  • Patients must have a hemoglobin level greater than 10.0 grams per deciliter (g/dL). Hemoglobin is a protein in red blood cells that carries oxygen.
  • Patients must have a platelet count greater than 100 billion per liter (100 x 109/L). Platelets are cells that help with blood clotting.
  • Patients must have certain liver enzymes (ALT, AST, GGT, and Lipase) at levels no more than 1.5 times the normal upper limit. These enzymes help assess liver function.
  • Patients must have a serum creatinine level less than 1.5 times the normal upper limit. Creatinine is a waste product in the blood that indicates kidney function.
  • Any side effects from previous treatments must have improved to a mild level, except for hair loss.
  • Women who can have children must have a negative pregnancy test and use effective birth control methods during the study and for three months after the last treatment.
  • Male patients with partners who can have children must agree to use two forms of birth control during the study and for three months after the last treatment.
  • Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.

Who cannot join the trial?

5 criteria

  • Patients who have cancer that has spread to other parts of the body (metastatic cancer).
  • Patients who have cancer that has spread to the lymph nodes (node positive).
  • Patients who are eligible for surgery or radiation therapy, meaning they can have these treatments.
  • Patients who do not have a histological evaluation, which is a test that looks at tissue under a microscope to check for cancer.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • L19IL2

    is a medication used in this trial that is administered directly into the tumor. It is designed to help the body's immune system recognize and attack cancer cells more effectively. This medication combines a specific protein that targets cancer cells with a substance that stimulates the immune system.

  • L19TNF

    is another medication used in the trial, also administered directly into the tumor. It works by targeting cancer cells and delivering a substance that can cause the death of these cells. This medication aims to reduce the size of the tumors and improve the overall response to treatment.

What is already known about the treatment

L19IL2/L19TNF – This medication is administered through intratumoral injection, specifically targeting non-melanoma skin cancers such as Basal Cell Carcinoma (BCC) and cutaneous Squamous Cell Carcinoma (cSCC) in patients who are not suitable for surgery or radiation. Currently, it is being studied in clinical trials to evaluate its effectiveness in treating these types of skin cancer. The main therapeutic indication is for patients with high-risk, locally advanced skin cancers that are amenable to direct injection. At the molecular level, L19IL2/L19TNF works by combining two proteins, IL2 and TNF, which help stimulate the immune system to attack cancer cells. It is classified as an immunotherapy, aiming to enhance the body's natural defenses to fight cancer.

Investigated diseases

  • Basal Cell Carcinoma (BCC)

    This is a type of skin cancer that begins in the basal cells, which are found in the outermost layer of the skin. It typically appears as a slightly transparent bump on the skin, though it can take other forms. BCC grows slowly and is most often found on areas of the skin that are frequently exposed to the sun, such as the head and neck. While it rarely spreads to other parts of the body, it can grow into nearby areas and invade bone or other tissues beneath the skin if not treated. BCC is the most common form of skin cancer and is often linked to long-term exposure to ultraviolet (UV) radiation from sunlight.

  • Cutaneous Squamous Cell Carcinoma (cSCC)

    This is a common form of skin cancer that arises from the squamous cells, which make up most of the skin's upper layers. It often manifests as a red, scaly patch, open sore, or wart-like growth that may crust or bleed. cSCC is primarily caused by cumulative UV exposure over a lifetime, and it is more likely to occur on sun-exposed areas of the body, such as the face, ears, neck, lips, and backs of the hands. Unlike basal cell carcinoma, cSCC can sometimes spread to other parts of the body, though this is less common. It is generally more aggressive than BCC and can cause significant damage if not addressed.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518530-92-00Protocol codePHL19IL2TNFNMSC04/19Estimated enrolment92 patientsSponsorPhilogen S.p.A.

sourced from the EU Clinical Trials Register and site verification

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