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 study about?

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.

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.

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.

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.

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.

5 surgery

All participants will undergo surgery to remove melanoma lesions. The timing of the surgery will be scheduled according to the study plan.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario Virgen Macarena	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital General Universitario De Valencia	Valencia	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
MD Anderson Cancer Center	Madrid	Spain
Fundacion Onkologikoa Fundazioa	Donostia / San Sebastian	Spain
Hcslcxza Ujgejzbmliuti Rjkczeqo Dl Mmazjv	Malaga	Spain
Uluhpjkhkkkqbtkpnvflg Erqwm Azc	Essen	Germany
Uhcngthmlofjxbpoezrsc Aklrczdg	Augsburg	Germany
Hpelciat Dv Lb Smjgq Clcb I Stub Pkl	Barcelona	Spain
Hnfldyss Urgwbqjioitkn Hfgsnitn Tewrv y Pwjwtu Ijqiyxib Cfwkjz drppfdijwyvszvsnu (frag	Badalona	Spain
Hbtcfvlk Voaw dckbrhbj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.10.2021
Italy	Recruiting	01.10.2021
Spain	Recruiting	01.10.2021
Sweden	Recruiting	01.10.2021

Trial locations

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.

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.

Trial ID:

2023-507119-36-00

Protocol code:

PH-L19IL2TNF-01/18

NCT ID:

NCT03567889

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?