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Study on the Effectiveness and Safety of L19TNF and Dacarbazine for Patients with Advanced or Metastatic Soft-Tissue Sarcoma After Previous Treatments

Verified siteRegistered drugNo 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 a type of cancer known as soft-tissue sarcoma, which is a cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. The study is specifically for patients whose cancer cannot be removed by surgery or has spread to other parts of the body, and who have already tried at least two other treatments without success. The trial will test a new treatment combination to see if it can help these patients. The treatment being studied includes a new drug called L19TNF, which is a fusion of a human antibody and a protein that can target tumors, and it will be used together with another drug called dacarbazine, which is a chemotherapy medication.

The purpose of the study is to find out if the combination of L19TNF and dacarbazine can help patients live longer without their cancer getting worse, compared to using dacarbazine alone. Patients in the study will receive the treatment through an intravenous infusion, which means the medication will be given directly into a vein. Some patients will receive the combination of both drugs, while others will receive only dacarbazine or a placebo. The study will last for a period of up to 48 weeks, during which time patients will be monitored regularly to check on their health and the progress of their cancer.

Throughout the study, doctors will look at how well the treatment works by measuring how long patients live without their cancer getting worse, which is known as progression-free survival. They will also look at overall survival, which is the length of time patients live after starting the treatment. This study aims to provide new insights into the treatment of advanced or metastatic soft-tissue sarcoma and potentially offer a new option for patients who have not had success with other treatments.

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

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and previous treatments for soft-tissue sarcoma.

    A physical examination and laboratory tests are performed to ensure all criteria are met.

  2. Step 2

    Treatment plan discussion

    The treatment plan is explained, including the use of two medications: dacarbazine and onfekafusp alfa (Fibromun).

    The purpose of the study is to evaluate the effectiveness of these medications in combination for treating advanced or metastatic soft-tissue sarcoma.

  3. Step 3

    Medication administration

    The medications are administered through an intravenous infusion. This means the drugs are given directly into a vein.

    Dacarbazine is provided as a 1000 mg powder that is mixed into a solution for infusion.

    Onfekafusp alfa (Fibromun) is also given as a solution for injection or infusion.

  4. Step 4

    Treatment cycle

    The treatment is given in cycles. Each cycle includes specific days when the medications are administered, followed by a rest period.

    The exact schedule and duration of each cycle are determined by the study protocol and the patient's response to treatment.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical exams, blood tests, and imaging studies like CT scans.

    Progression-free survival (PFS) is a key measure, which refers to the length of time during and after treatment that the disease does not worsen.

  6. Step 6

    Completion of study

    The study is expected to continue until June 2025. Participation may end earlier if the disease progresses or if there are significant side effects.

    After completing the study, a final assessment is conducted to evaluate overall survival and any long-term effects of the treatment.

Who can join the trial?

11 criteria

  • Must be a male or female between 18 to 80 years old.
  • Must have a confirmed diagnosis of advanced **unresectable** or **metastatic** soft tissue sarcoma. This means the cancer cannot be removed by surgery and has spread to other parts of the body.
  • Must have received at least two previous treatments for advanced or metastatic disease. One of these treatments should have included **anthracyclines**, a type of cancer drug, unless there is a medical reason not to use them.
  • Must show evidence that the disease has worsened after previous treatments.
  • Must have at least one measurable tumor that can be seen on a **computed tomography (CT)** scan. If there is only one tumor, it should not have been treated with radiation before.
  • Must have a life expectancy of at least 3 months, as judged by the doctor.
  • Must have an **ECOG** performance status of 2 or less. This is a scale used to assess how a disease affects a patient's daily living abilities, with lower numbers indicating better function.
  • Must test negative for **HIV**, **HBV** (Hepatitis B), and **HCV** (Hepatitis C). If there is a history of Hepatitis B, additional tests are required to ensure no current infection.
  • Female patients who can have children must have a negative pregnancy test and agree to use effective birth control methods during the study and for six months after the last treatment. Male patients must also agree to use two forms of birth control during the same period.
  • 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.

Who cannot join the trial?

4 criteria

  • Patients who have not tried at least two different treatments for their **unresectable** (cannot be removed by surgery) or **metastatic** (cancer that has spread to other parts of the body) soft-tissue sarcoma.
  • Patients who have only received **neoadjuvant** (treatment given before the main treatment) or **adjuvant** (treatment given after the main treatment) therapies, as these do not count as prior treatments for this study.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • L19TNF

    is a medication being studied for its potential to target tumors in patients with advanced or metastatic soft-tissue sarcoma. It is a fusion protein that combines a human antibody with a cytokine, which may help the immune system recognize and attack cancer cells more effectively.

  • DTIC

    , also known as Dacarbazine, is a chemotherapy drug used to treat certain types of cancer, including soft-tissue sarcoma. It works by slowing or stopping the growth of cancer cells. In this trial, DTIC is used both alone and in combination with L19TNF to evaluate its effectiveness in prolonging progression-free survival in patients.

What is already known about the treatment

L19TNF – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic soft-tissue sarcoma, particularly after other treatments have failed. It is a fusion protein that combines a human antibody with a cytokine, specifically targeting tumor cells to enhance the immune response against them. L19TNF is classified as a tumor-targeting antibody-cytokine fusion protein, and its mechanism involves binding to specific markers on tumor cells, allowing the cytokine to stimulate an immune attack on the cancer.

Investigated diseases

Soft-Tissue Sarcoma – Soft-tissue sarcoma is a type of cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease can be unresectable, meaning it cannot be removed completely through surgery, or metastatic, indicating it has spread to other parts of the body. It often progresses by growing in size or spreading to other areas, making it more challenging to manage. The progression of the disease can vary significantly depending on the type and location of the sarcoma. It is typically diagnosed after other systemic therapies have failed to control the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512704-20-00Protocol codePH-L19TNFSARC-03/18Estimated enrolment98 patientsSponsorPhilogen S.p.A.

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