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Study on L19IL2 and L19TNF Treatment Before Surgery for Patients with Advanced Melanoma

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 the treatment of malignant melanoma, a type of skin cancer. The study involves two medications, Fibromun and Darleukin, which are used as a solution for injection or infusion. These medications contain active substances called onfekafusp alfa and bifikafusp alfa, respectively. The purpose of the study is to evaluate the effectiveness of these medications when used as a neoadjuvant treatment, which means they are given before surgery to help improve outcomes.

Participants in the study will be randomly assigned to one of two groups. One group will receive the neoadjuvant treatment with Fibromun and Darleukin followed by surgery, while the other group will undergo surgery alone. The study aims to determine if the combination of these medications with surgery can significantly improve the time patients remain free from cancer recurrence compared to surgery alone. Both groups may receive additional treatment after surgery if needed.

The study will take place over a period of time, with regular follow-up visits to monitor the participants' health and response to the treatment. The safety of the medications and their effects on the body will also be closely observed. This trial is an important step in exploring new ways to treat malignant melanoma and potentially improve the quality of life for those affected by this condition.

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

    Joining the study

    Upon joining the study, the patient is assigned to one of two groups: the treatment group or the control group.

    The treatment group receives the L19IL2 and L19TNF medications, while the control group undergoes surgery alone.

  2. Step 2

    Treatment administration

    Patients in the treatment group receive Fibromun and Darleukin, which are solutions for injection or infusion.

    These medications are administered directly into the tumor (intratumoral use).

  3. Step 3

    Surgery

    After the treatment phase, patients in both groups undergo surgery to remove the melanoma.

    The surgery aims to completely resect the melanoma.

  4. Step 4

    Post-surgery follow-up

    Following surgery, patients are monitored for recurrence-free survival (RFS), which is the primary endpoint of the study.

    Additional assessments include overall survival (OS), local recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS).

  5. Step 5

    Safety and biomarker studies

    The safety of the intratumoral administration of L19IL2 and L19TNF is evaluated.

    Biomarker studies are conducted to analyze changes in blood cells and the formation of antibodies against the medications.

  6. Step 6

    Study duration

    The study is expected to conclude by August 31, 2028.

    Patients are followed up throughout the study duration to assess the long-term effects and outcomes.

Who can join the trial?

19 criteria

  • Must have a diagnosis of malignant melanoma of the skin with locally advanced disease, specifically stage III B or III C, and be eligible for complete surgical removal.
  • Total bilirubin level must be 30 micromoles per liter or less (or 2.0 milligrams per deciliter or less). Bilirubin is a substance made by the liver.
  • ALT and AST levels must be 2.5 times or less than the upper limit of normal. These are enzymes that help check liver function.
  • Serum creatinine must be less than 1.5 times the upper limit of normal. Creatinine is a waste product in the blood that comes from muscles.
  • LDH serum level must be 1.5 times or less than the upper limit of normal. LDH is an enzyme found in almost all body tissues.
  • Must have a negative test for HIV, HBV (Hepatitis B), and HCV (Hepatitis C). For Hepatitis B, specific tests are required, and if there was past exposure, a negative HBV-DNA test is also needed.
  • 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 study drug. Pregnant women cannot participate.
  • Men with partners who can have children must use two forms of birth control during the study and for three months after the last study drug.
  • Must provide a signed and dated consent form showing understanding of the study details.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures.
  • Must have measurable disease and be a candidate for treatment with at least one injectable melanoma lesion that is 10 millimeters or larger, or multiple lesions that together are 10 millimeters or larger.
  • Previous treatments for the primary melanoma, like surgery or approved therapies, are allowed.
  • Must be 18 years or older.
  • Must have an ECOG Performance Status or WHO Performance Status of 1 or less, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have a life expectancy of at least 24 months.
  • Must have an absolute neutrophil count greater than 1.5 x 109/L. Neutrophils are a type of white blood cell important for fighting infections.
  • Must have a hemoglobin level greater than 9.0 grams per deciliter. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Must have platelets greater than 100 x 109/L. Platelets are cells that help with blood clotting.

Who cannot join the trial?

5 criteria

  • Patients with other types of cancer besides the specific type of skin cancer being studied.
  • Patients whose melanoma cannot be surgically removed.
  • Patients who do not have any skin or under-the-skin lumps that can be injected.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • L19IL2

    is a medication used in this clinical trial as a neoadjuvant treatment. It is administered directly into the tumor to help shrink it before surgery. This medication is designed to enhance the body's immune response against the melanoma, potentially improving the chances of successful surgery and reducing the risk of the cancer coming back.

  • L19TNF

    is another medication used in combination with L19IL2 for neoadjuvant treatment. Like L19IL2, it is injected into the tumor to help reduce its size before surgical removal. L19TNF works by targeting and destroying cancer cells, which may help improve the effectiveness of the surgery and decrease the likelihood of melanoma recurrence.

What is already known about the treatment

  • L19IL2

    This medication is administered through intratumoral injection, directly into the tumor. It is currently being studied in clinical trials for its effectiveness in treating malignant melanoma of the skin, specifically in patients with locally advanced and fully resectable melanoma. The main therapeutic indication is to improve recurrence-free survival when used as a neoadjuvant treatment before surgery. At the molecular level, L19IL2 works by targeting tumor cells and stimulating the immune system to attack the cancer. It is classified as an immunotherapy agent.

  • L19TNF

    This medication is also administered via intratumoral injection. It is under investigation in clinical trials for its potential to treat malignant melanoma of the skin in patients with locally advanced and fully resectable melanoma. The primary therapeutic goal is to enhance recurrence-free survival when used as a neoadjuvant treatment prior to surgical intervention. L19TNF functions by binding to tumor cells and inducing an immune response to destroy the cancerous cells. It is categorized as an immunotherapy drug.

Investigated diseases

Malignant Melanoma of the Skin – This is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It is characterized by the uncontrolled growth of these pigment-producing cells, which can form a malignant tumor. The disease can progress from a localized area on the skin to more advanced stages where it may spread to other parts of the body, including lymph nodes and internal organs. In its early stages, malignant melanoma may appear as a new mole or a change in an existing mole, often with irregular borders and multiple colors. As it advances, it can become more invasive, affecting deeper layers of the skin and potentially leading to metastasis. Early detection and monitoring of changes in skin appearance are crucial for managing the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515749-40-00Protocol codePH-L19IL2TNF-02/15Estimated enrolment256 patientsSponsorPhilogen S.p.A.

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