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Study of L19TNF (onfekafusp alfa) with temozolomide chemoradiotherapy for newly diagnosed glioblastoma patients

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 study focuses on patients with newly diagnosed glioblastoma, which is an aggressive type of brain tumor. The research evaluates a combination treatment approach using a new medication called L19TNF (also known as Fibromun) together with standard temozolomide chemotherapy and radiation therapy.

The treatment involves receiving L19TNF through intravenous infusion alongside oral temozolomide capsules and radiation therapy. The purpose of this research is to determine if adding L19TNF to the standard treatment is safe and effective for patients with newly diagnosed glioblastoma.

The study is conducted in multiple phases to first establish the appropriate dose and then evaluate how well the treatment works. Throughout the study, patients will undergo regular medical check-ups, including brain scans to monitor their condition. The treatment combines different approaches to fighting the tumor: targeted therapy with L19TNF, chemotherapy with temozolomide, and radiation therapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Treatment begins with a combination of two medications: temozolomide (taken as oral capsules) and Fibromun (given through intravenous infusion)

    This phase includes standard chemoradiotherapy (combined treatment with chemotherapy and radiation therapy)

  2. Step 2

    Regular monitoring

    Your condition will be monitored through standardized MRI scans at weeks 10, 22, 34, 46, and 58

    Regular health assessments will track any changes in your condition

    Blood tests will be performed to monitor your response to the treatment

  3. Step 3

    Safety monitoring

    Your doctor will monitor for any side effects throughout the treatment

    Regular blood tests will check your body's response to the medications

    The formation of antibodies against the treatment will be assessed

  4. Step 4

    Long-term follow-up

    Your progress will be monitored for up to 12 months (52 weeks)

    Regular assessments will continue to track your response to treatment

    Brain scans will be performed according to a set schedule to monitor any changes in your condition

  5. Step 5

    Study completion

    The study is expected to continue until December 31, 2029

    Your participation duration will depend on your individual treatment plan and response

Who can join the trial?

13 criteria

  • Age 18 years or older
  • Must have a newly diagnosed glioblastoma confirmed through tissue examination
  • Must have a Karnofsky Performance Score of 70% or higher (this means being able to care for yourself but unable to carry on normal activity or work)
  • Must test negative for HIV, Hepatitis B, and Hepatitis C
  • For women who can become pregnant:
    • Must have a negative pregnancy test within 14 days before starting treatment
    • Must use effective birth control methods from screening until 6 months after the last study treatment
    • For men who can father children:
      • Must use two acceptable birth control methods throughout the study
      • Must use double-barrier contraception (such as condom with spermicidal gel)
      • Must sign an informed consent document showing understanding of all study aspects
      • Must be willing and able to:
        • Attend all scheduled visits
        • Follow the treatment plan
        • Complete required laboratory tests
        • Comply with other study procedures

Who cannot join the trial?

15 criteria

  • Age below 18 years or over 70 years
  • Previous treatment with chemotherapy or radiation therapy for brain tumors
  • Presence of other types of cancer besides glioblastoma
  • Severe heart, liver, or kidney problems
  • Uncontrolled high blood pressure
  • Active infections that require treatment
  • Pregnancy or breastfeeding
  • Known allergic reactions to similar treatments
  • Unable to undergo MRI scans (such as having metal implants or severe claustrophobia)
  • Participation in other clinical trials within the last 30 days
  • Mental conditions that could interfere with providing informed consent
  • History of autoimmune diseases (conditions where the body's immune system attacks healthy cells)
  • Major surgery within the last 4 weeks
  • Use of medications that could interfere with the study treatment
  • Inability to follow the study protocol or attend required visits
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Investigated drugs

L19TNF is an experimental antibody-cytokine fusion protein that targets tumors. It's designed to work alongside standard cancer treatments to help fight glioblastoma, which is a type of brain cancer. This medication aims to specifically target tumor tissues while minimizing effects on healthy cells. Temozolomide is a chemotherapy medication used to treat certain types of brain tumors. It works by stopping or slowing the growth of cancer cells. It's commonly used as a standard treatment for glioblastoma and is taken orally. Chemoradiotherapy is a combined treatment approach that uses both chemotherapy and radiation therapy together. The radiation therapy uses high-energy rays to target and destroy cancer cells, while the chemotherapy medication helps make the cancer cells more sensitive to the radiation treatment.

What is already known about the treatment

  • L19TNF

    An innovative antibody-cytokine fusion protein administered as part of combination therapy for glioblastoma treatment. This experimental medication combines a tumor-targeting antibody (L19) with tumor necrosis factor (TNF), designed to specifically target cancer cells while working alongside standard temozolomide chemoradiotherapy. The medication is currently being investigated in clinical trials to establish its safety profile and optimal dosing for newly diagnosed glioblastoma patients, representing a novel approach in targeted cancer therapy.

  • Temozolomide

    An oral chemotherapy medication used as the standard treatment for glioblastoma, administered in combination with radiation therapy. This drug works by damaging cancer cell DNA, which prevents the cells from reproducing and causes them to die, and it can cross the blood-brain barrier effectively to reach brain tumors. Temozolomide is classified as an alkylating agent and is typically given daily during radiation therapy, followed by a maintenance schedule of higher doses for several days every month.

Investigated diseases

Glioblastoma – A type of brain tumor that develops from star-shaped cells called astrocytes in the brain and spinal cord. It forms a mass of abnormal cells that grows in the brain tissue, typically in the cerebral hemispheres. The tumor can grow rapidly, creating pressure within the brain and interfering with normal brain function. Glioblastoma can cause various symptoms depending on its location, including headaches, seizures, confusion, and changes in vision or speech. As the tumor grows, it forms its own blood vessel network to maintain its growth.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516357-46-00Protocol codePH-L19TNFTMZ-01/20Estimated enrolment270 patientsSponsorPhilogen S.p.A.

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