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Study on How Bevacizumab Affects the Immune System in Patients with Glioblastoma Multiforme

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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 brain cancer known as glioblastoma multiforme. The treatment being investigated is called bevacizumab, which is administered through an intravenous infusion. The purpose of the study is to observe changes in the immune system of patients with glioblastoma multiforme who are treated with bevacizumab.

During the study, participants will receive bevacizumab infusions over a period of time. Researchers will monitor the immune system changes in these patients to understand how the treatment might affect the progression of the disease. The study will also look at how long patients remain free from local relapse, how long the disease does not worsen, and overall survival rates.

Additionally, the study will explore certain components in the blood, such as extracellular vesicles, which are tiny particles released by cells, and their content, including micro-RNA and protein, as well as free DNA-RNA fragments. This research aims to provide insights into the biological changes occurring in patients with glioblastoma multiforme during treatment with bevacizumab.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to assess changes in the immune system in patients with a type of brain cancer called glioblastoma multiforme who are treated with a medication called bevacizumab.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather information about your health status. This may include physical examinations and laboratory tests to ensure you meet the study criteria.

  3. Step 3

    Treatment administration

    You will receive bevacizumab through an intravenous infusion. This means the medication will be given directly into your vein. The dosage is 25 mg/ml, and the frequency and duration of administration will be determined by the study team based on your specific condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to observe any changes in your immune system and to assess the progression of the disease. The study aims to understand how bevacizumab affects your condition and overall survival.

  5. Step 5

    End of study

    The study is expected to conclude by December 31, 2029. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any changes observed during the treatment period.

Who can join the trial?

6 criteria

  • Patients must have a diagnosis of glioblastoma multiforme, which is a type of brain cancer.
  • Patients should not have a recurrent glioblastoma, meaning the cancer has not come back after initial treatment, and they should be before receiving radiotherapy (treatment using radiation) and temozolomide therapy (a type of chemotherapy).
  • Patients who have a recurrent glioblastoma and have already had treatments like surgery, radiotherapy, and temozolomide therapy can participate if it is appropriate to start bevacizumab therapy (a treatment that helps stop the growth of blood vessels that feed tumors).
  • Patients who have a known relapse and are already receiving bevacizumab therapy are eligible.
  • Both male and female patients can participate.
  • Patients must be within the age range of 18 to 64 years.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious medical conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to bevacizumab or any of its components. Bevacizumab is a medication used in the treatment of certain types of cancer.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of bleeding disorders.
  • Patients who have had a stroke or heart attack within the last 6 months.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

Bevacizumab is a medication used in this clinical trial to treat patients with glioblastoma multiforme, a type of brain cancer. It works by blocking a protein called vascular endothelial growth factor (VEGF), which helps tumors form new blood vessels. By inhibiting this protein, bevacizumab can slow down the growth of the tumor by cutting off its blood supply, which is essential for its growth and survival. This medication is given through an infusion, meaning it is administered directly into the bloodstream through a vein, allowing it to circulate throughout the body and reach the tumor effectively.

What is already known about the treatment

Bevacizumab – Bevacizumab is administered through an infusion, which means it is given directly into the bloodstream via a vein. It is currently being studied in a Phase IV clinical trial to understand its effects on the immune system in patients with glioblastoma multiforme, a type of brain cancer. The main use of bevacizumab is to treat various types of cancer by inhibiting the growth of blood vessels that supply nutrients to tumors. At the molecular level, it works by blocking a protein called vascular endothelial growth factor (VEGF), which is responsible for the formation of new blood vessels. Bevacizumab is classified as an anti-angiogenic medication, meaning it prevents the growth of new blood vessels.

Investigated diseases

Glioblastoma multiforme – Glioblastoma multiforme is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and a tendency to invade nearby brain tissue, making it difficult to remove completely through surgery. The disease often leads to increased pressure within the skull, causing symptoms such as headaches, nausea, and changes in mental function. As the tumor grows, it can affect various brain functions depending on its location, leading to symptoms like seizures, weakness, or speech difficulties. Glioblastoma multiforme is known for its aggressive nature and ability to recur even after treatment. The progression of the disease can vary, but it typically involves a continuous increase in tumor size and worsening of neurological symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512136-30-00Estimated enrolment175 patientsSponsorOrszagos Onkologiai Intezet

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