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A study of onfekafusp alfa and bifikafusp alfa injected into tumors for patients with advanced skin squamous cell cancer who did not respond to or could not tolerate previous treatment

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 study involves patients with Cutaneous Squamous Cell Carcinoma, which is a type of skin cancer that develops in the outer layer of the skin. The study is for patients whose cancer has grown larger or spread in the local area and who have either not responded well to previous treatment or could not tolerate it. The treatments being tested are two medications called Fibromun and Darleukin, which contain the active substances onfekafusp alfa and bifikafusp alfa. These medications will be given by injection directly into the tumor, which means the medicine is injected straight into the cancer lesion rather than being given into a vein or taken by mouth.

The purpose of this study is to evaluate how well the combination of these two medications works when injected directly into the tumor in patients with locally advanced skin cancer who have previously tried other treatments. The study will look at whether the tumors shrink or stop growing after receiving this treatment. During the study, patients will receive injections of both medications into their tumors over a treatment period. The doctors will monitor the tumors to see how they respond to the treatment and will take tissue samples from the tumor before treatment starts and later to check the response.

Patients participating in this study must have at least one tumor that can be injected and measured. The study requires patients to be generally well enough to carry out daily activities with some limitations. Blood tests will be performed to ensure that patients have adequate levels of blood cells and that their liver is functioning properly. Women who could become pregnant must have a negative pregnancy test, and male patients with partners who could become pregnant must use two methods of birth control during the study. Patients will need to attend scheduled visits and follow the treatment plan throughout the study.

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 and baseline procedures

    At the beginning of the study, a tissue sample will be obtained from one of your tumors through a core biopsy or excisional biopsy. A core biopsy involves removing a small cylinder of tissue using a hollow needle, while an excisional biopsy removes a larger piece of tissue surgically.

    Your overall health status will be assessed to confirm eligibility for the study. This includes blood tests to check hemoglobin (a protein in red blood cells that carries oxygen), platelet count (cells that help blood clot), and liver function through measurements of ALT, AST, GGT (enzymes produced by the liver), and lipase (an enzyme produced by the pancreas).

    If you are a woman of childbearing potential, a pregnancy test will be performed to ensure you are not pregnant.

    Your physical condition will be evaluated using a standardized scale that measures your ability to perform daily activities.

  2. Step 2

    Treatment administration

    You will receive treatment with two medications: Fibromun (also known as onfekafusp alfa) and Darleukin (also known as bifikafusp alfa).

    Both medications will be administered as intratumoral injections, meaning they will be injected directly into your tumor lesions.

    The medications are provided as solutions for injection or infusion.

    The specific dosage, frequency of administration, and total duration of treatment are determined by the study protocol and will be explained to you by the study staff.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, your tumors will be measured regularly to evaluate how they respond to treatment.

    Response to treatment will be assessed according to RECIST 1.1 criteria, which is a standardized method for measuring changes in tumor size.

    An Independent Central Review will evaluate your tumor measurements. This means that specialists who are not directly involved in your care will review your imaging results to provide an objective assessment.

    Regular blood tests and physical examinations will be conducted to monitor your health and detect any potential side effects of the treatment.

  4. Step 4

    Confirmation biopsies

    If your tumors show a response to treatment or remain stable, an additional tissue biopsy will be required to confirm these findings.

    This confirmation biopsy will be performed in the same manner as the initial biopsy, either as a core biopsy or excisional biopsy.

  5. Step 5

    Contraception requirements during treatment

    If you are a male patient with a female partner who can become pregnant, you must agree to use two acceptable methods of contraception simultaneously throughout the treatment period.

    This requirement is in place to prevent pregnancy during the study, as the effects of the study medications on pregnancy are not fully known.

  6. Step 6

    Follow-up period

    After completing the treatment phase, you will continue to be monitored for a specified period.

    During this time, assessments will continue to evaluate the long-term effects of the treatment and monitor your overall health status.

    Any side effects or changes in your condition will be documented and managed as needed.

Who can join the trial?

16 criteria

  • You must have cutaneous squamous cell carcinoma, which is a type of skin cancer that has been confirmed by examining tissue under a microscope
  • Your cancer must be locally advanced, meaning it has grown larger or spread to nearby areas but not to distant parts of the body
  • You must have at least one tumor that can be injected with medication and measured, located on or under the skin
  • Your cancer must have gotten worse while receiving previous treatment with immune checkpoint inhibitors (medicines that help your immune system fight cancer), or you were unable to tolerate this type of treatment
  • A group of cancer specialists at your treatment center must have reviewed your case and confirmed you meet the requirements
  • You may have cancer that has spread to nearby lymph nodes (small bean-shaped organs that are part of your immune system), nearby areas, or along the path between the original tumor and lymph nodes
  • You must be willing to have a tissue sample taken from your tumor at the beginning of the study and again later if your tumor responds to treatment or stays stable
  • You must be between 18 and 100 years old
  • Your ability to carry out daily activities must be good to moderate, rated 2 or better on a standard scale used by doctors
  • Your hemoglobin level (a protein in red blood cells that carries oxygen) must be above 10.0 grams per deciliter
  • Your platelet count (cells that help blood clot) must be above 100,000 per microliter
  • Your liver function tests, including ALT, AST, and GGT (enzymes that show how well your liver is working), and lipase (an enzyme from the pancreas) must be no more than 1.5 times the normal upper limit
  • Any side effects from previous cancer treatments must have improved to mild or gone away completely, except for hair loss
  • If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study
  • If you are a man with a female partner who can become pregnant, you must agree to use two reliable methods of birth control at the same time
  • You must be willing and able to attend all scheduled visits, follow the treatment plan, complete required blood tests, and participate in all study procedures

Who cannot join the trial?

8 criteria

  • The study does not list specific exclusion criteria in the provided information, meaning detailed reasons why patients cannot participate are not available in this data
  • Generally, clinical trials may exclude patients based on factors such as other serious health conditions, previous treatments, or laboratory test results that fall outside acceptable ranges
  • Patients who are currently receiving certain medications or treatments that could interfere with the study drug may not be eligible
  • Women who are pregnant, which means carrying an unborn baby, or breastfeeding, which means feeding a baby with milk from the breast, are typically excluded from such studies
  • Patients with known allergies, which are reactions where the body's defense system responds to a substance in a harmful way, to any components of the study treatment may not be able to participate
  • Individuals with severe problems with major organs such as the heart, liver, or kidneys may be excluded
  • Patients with active infections or diseases that affect the body's defense system may not be eligible
  • Those who have participated in another clinical trial within a certain time period before this study may be excluded
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Investigated drugs

  • L19IL2

    is an experimental medication made by combining a special antibody (called L19) with a protein called interleukin-2 (IL2). The antibody is designed to find and attach to cancer cells, while the IL2 part helps activate the body's immune system to fight the cancer. In this study, it is injected directly into the tumor.

  • L19TNF

    is an experimental medication made by combining the same special antibody (L19) with a different protein called tumor necrosis factor (TNF). Like L19IL2, the antibody targets cancer cells, but the TNF part works differently - it can help destroy tumor blood vessels and directly damage cancer cells. In this study, it is also injected directly into the tumor.

What is already known about the treatment

  • L19IL2

    L19IL2 is an experimental immunotherapy medication given by injection directly into tumors, currently being studied in clinical trials for treating advanced skin cancer called cutaneous squamous cell carcinoma. This medication works by combining a targeted antibody fragment (L19) that finds specific proteins in tumor blood vessels with interleukin-2 (IL2), a substance that activates the body's immune system to attack cancer cells. It belongs to a class of drugs called immunocytokines, which are designed to concentrate immune-boosting effects specifically at the tumor site while reducing side effects in other parts of the body.

  • L19TNF

    L19TNF is an investigational cancer treatment administered by injection directly into tumors, currently being evaluated in clinical trials for patients with advanced cutaneous squamous cell carcinoma who have not responded to or cannot tolerate standard treatments. This medication combines a targeting antibody fragment (L19) that recognizes markers on tumor blood vessels with tumor necrosis factor (TNF), a protein that can destroy cancer cells and cut off their blood supply. It is classified as an immunocytokine, a type of targeted therapy that delivers powerful anti-cancer substances directly to the tumor environment to maximize effectiveness while minimizing harm to healthy tissues.

Investigated diseases

Cutaneous Squamous Cell Carcinoma – This is a type of skin cancer that develops in the squamous cells, which are flat cells found in the outer layer of the skin. The disease begins when these cells start to grow abnormally and out of control, forming a tumor. It typically appears as a firm, red bump or a flat sore with a scaly crust on sun-exposed areas of the skin. The condition can progress from a small lesion to a larger growth that may invade deeper layers of skin. In locally advanced stages, the tumor grows larger and may spread to nearby tissues. Without intervention, the cancer cells can continue to multiply and the tumor can expand in size and depth.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523231-19-00Estimated enrolment131 patientsSponsorPhilogen S.p.A.

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