Recruiting

Study on the Effectiveness of L19IL2 and L19TNF Injections with Surgery for Patients with Stage IIIB/C Melanoma

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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 effects of a treatment called Daromun on patients with Stage IIIB/C melanoma, a type of skin cancer that has advanced locally but can still be surgically removed. The treatment involves two medications, Darleukin and Fibromun, which are injected directly into the tumor. These medications contain special proteins, bifikafusp alfa and onfekafusp alfa, designed to help the body fight cancer cells.

The purpose of the study is to see if using Daromun before surgery, followed by standard post-surgery treatments, can improve the time patients remain free from cancer recurrence compared to just having surgery and post-surgery treatments. Participants will be randomly assigned to receive either the Daromun treatment followed by surgery or just the surgery and post-surgery treatments. The study will monitor patients over a period to assess the effectiveness of the treatment in preventing the return of cancer.

Throughout the study, patients will receive regular injections of the medications directly into their tumors, followed by surgery to remove the cancer. After surgery, they will continue with standard treatments to help prevent the cancer from coming back. The study aims to provide valuable information on whether this new approach can offer better outcomes for patients with advanced melanoma.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the trial's purpose, procedures, and potential risks and benefits. A signed informed consent document is required to confirm understanding and agreement to participate.
Step 2
Initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history, physical examination, and laboratory tests to ensure all criteria are met.
Step 3
Treatment allocation
Participants will be randomly assigned to one of two groups. One group will receive the Daromun treatment followed by surgery and additional therapy, while the other group will undergo surgery and additional therapy without the Daromun treatment.
Step 4
Daromun treatment
For those in the Daromun group, the treatment involves intratumoral injections of L19IL2 and L19TNF. These are solutions for injection administered directly into the tumor. The frequency and duration of these injections will be determined by the study protocol.
Step 5
Surgery
All participants will undergo surgery to remove melanoma lesions. The timing of the surgery will be scheduled according to the study plan.
Step 6
Adjuvant therapy
Following surgery, participants will receive additional therapy to help prevent the recurrence of melanoma. The specific type of adjuvant therapy will be based on the study's guidelines.
Step 7
Follow-up visits
Participants will attend regular follow-up visits to monitor their health and the effectiveness of the treatment. These visits will include physical exams, imaging tests, and laboratory tests as needed.
Step 8
Safety visit
A safety visit will be conducted to ensure there are no adverse effects from the treatment. For women of childbearing potential, a pregnancy test will be repeated during this visit.
Step 9
End of study
The study will conclude with a final assessment to evaluate the overall outcomes and any long-term effects of the treatment. Participants will be informed of the study results once available.

Who can join the trial?

18 criteria

Must have a diagnosis of clinical stage IIIB or IIIC metastatic melanoma that can be completely removed by surgery.
Blood tests must show liver enzymes (ALT and AST) at or below 2.5 times the normal limit.
Serum creatinine, a kidney function marker, must be less than 1.5 times the normal limit.
LDH, a blood enzyme, must be at or below 1.5 times the normal limit.
Must have a negative test for HIV, HBV (Hepatitis B), and HCV (Hepatitis C). If previously exposed to HBV, a negative HBV-DNA test is also required.
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 highly effective birth control methods during the study and for three months after the last treatment.
Men with partners who can have children must use two forms of birth control, such as a condom and spermicidal gel, during the study and for three months after the last treatment.
Must have signed a consent form indicating understanding of the study details.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Must have measurable disease and be a candidate for treatment directly into the tumor with at least one injectable melanoma lesion that is 10 mm or larger, or multiple lesions that together measure 10 mm or more.
Must be 18 years of age or older.
Must have a performance status of 1 or less, meaning able to carry out light work or activities.
Must have a life expectancy of more than 24 months.
Must have an absolute neutrophil count, a type of white blood cell, greater than 1.5 x 10⁹/L.
Must have hemoglobin levels greater than 9.0 g/dL, indicating sufficient red blood cells.
Must have platelet levels greater than 100 x 10⁹/L, indicating sufficient blood clotting ability.
Total bilirubin, a liver function marker, must be at or below 30 μmol/L (or 2.0 mg/dL).

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides **malignant melanoma**.
Patients who have not fully recovered from previous cancer treatments.
Patients with **autoimmune diseases**, which are conditions where the immune system attacks the body.
Patients with **active infections** that are not controlled or treated.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to similar treatments.
Patients with significant heart problems.
Patients with **uncontrolled high blood pressure**.
Patients with **severe liver or kidney disease**.
Patients who are participating in another clinical trial.

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Verified sites

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Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

Daromun is a combination of two substances, L19IL2 and L19TNF, used in this clinical trial. It is given directly into the tumor to help the body's immune system fight melanoma, a type of skin cancer. The goal of using Daromun is to shrink the tumor before surgery, making it easier to remove and potentially improving the chances of the cancer not coming back after treatment.

What is already known about the treatment

Daromun – Daromun is administered as an injection directly into the tumor, known as intratumoral administration. It is currently being studied in clinical trials for its effectiveness in treating malignant melanoma of the skin, specifically in patients with locally advanced melanoma that can be surgically removed. The main goal of this treatment is to improve the time patients remain free from cancer recurrence after surgery. Daromun works by combining two substances, L19IL2 and L19TNF, which help the immune system target and destroy cancer cells. It is classified as an immunotherapy, a type of treatment that uses the body's own immune system to fight cancer.

Investigated diseases

Malignant Melanoma of the Skin – Malignant melanoma 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 typically begins as a mole or a dark spot on the skin that changes in size, shape, or color over time. As the disease progresses, the melanoma can grow deeper into the skin layers and may spread to nearby lymph nodes or other parts of the body. The progression of malignant melanoma is often categorized by stages, with early stages being localized to the skin and later stages involving metastasis to other organs. The growth and spread of melanoma can vary significantly between individuals, with some cases remaining localized for years and others spreading rapidly. Early detection and monitoring of changes in skin lesions are crucial in managing the progression of this disease.