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Study of Pembrolizumab Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme Patients

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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 Multiforme (GBM), which is an aggressive type of brain tumor. The research examines a treatment approach that combines standard therapy (known as the Stupp protocol) with a medication called Pembrolizumab (also known as Keytruda). The standard therapy includes both chemotherapy and radiation treatment.

The purpose of this research is to evaluate how safe and effective it is to add Pembrolizumab treatment both before and after the standard therapy for patients with Glioblastoma Multiforme. Pembrolizumab is given through intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The medication dose is 200 milligrams per treatment session.

During the study, participants will receive Pembrolizumab along with the standard combination of chemotherapy and radiation therapy. The treatment period may continue for up to 48 months. Throughout the study, doctors will monitor participants' health status and measure how well they are responding to the treatment. They will also track any side effects that may occur and assess the overall impact on patients' quality of life.

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

    You will receive pembrolizumab through an intravenous infusion (directly into your vein). The medication is called KEYTRUDA, with a concentration of 25 mg/mL.

    This treatment will be given before the standard brain tumor treatment (called neoadjuvant therapy).

  2. Step 2

    Standard treatment protocol

    You will undergo the standard treatment known as the Stupp protocol, which includes:

    Surgery to remove the brain tumor where possible

    Radiation therapy to the brain

    Chemotherapy treatment

  3. Step 3

    Continued treatment phase

    After completing the standard treatment, you will continue receiving pembrolizumab infusions (called adjuvant therapy)

    Regular health assessments will monitor your condition throughout the treatment period

  4. Step 4

    Monitoring and evaluation

    Your health status will be regularly assessed using various questionnaires that measure quality of life

    Brain scans will be performed to evaluate your response to treatment

    Blood tests will be conducted to monitor your organ function

    Any side effects will be recorded and monitored

  5. Step 5

    Study duration

    The study is scheduled to continue until January 2026

    Your participation will require maintaining the prescribed treatment schedule and attending all planned medical visits

Who can join the trial?

15 criteria

  • Patient must sign an informed consent form to participate in the study
  • Age requirements: must be between 18 and 70 years old
  • Women who can become pregnant must agree to either:
    • Remain abstinent, or
    • Use double barrier contraception methods during treatment and for 120 days after the last imaging scan
    • Men must agree to either:
      • Remain abstinent, or
      • Use double barrier contraception methods during treatment and for 120 days after the last imaging scan
      • Must be able to follow study protocol requirements
      • Must have confirmed Glioblastoma Multiforme diagnosis through brain scans (CT and MRI)
      • Tumor must be in a location where surgery is possible
      • Must have good physical performance (Karnofsky score of 80 or higher, meaning able to carry out normal activities with minimal symptoms)
      • Life expectancy of at least 3 months
      • Must have adequate organ function, including:
        • Acceptable blood counts (hemoglobin, white blood cells, platelets)
        • Normal liver function
        • Normal kidney function
        • Normal blood clotting measures

Who cannot join the trial?

15 criteria

  • History of autoimmune disease requiring systemic treatment in the past 2 years (a condition where the body's immune system attacks healthy cells)
  • Active hepatitis B or C infection (liver infections)
  • Known HIV infection or AIDS
  • Previous treatment with immune checkpoint inhibitors (a type of cancer immunotherapy)
  • Uncontrolled high blood pressure (above 150/90 mmHg)
  • Serious heart conditions, including:
    • Heart attack within last 6 months
    • Unstable chest pain
    • Severe heart rhythm problems
    • Active infection requiring systemic therapy (treatment that affects the whole body)
    • Other active cancers requiring treatment (except for non-melanoma skin cancer or cervical cancer in situ)
    • Pregnancy or breastfeeding
    • Known allergy or sensitivity to study medications
    • Participation in other clinical trials within 30 days before this study
    • Mental conditions that could interfere with study compliance
    • Life expectancy less than 3 months
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Investigated drugs

Pembrolizumab is a medication that helps your immune system fight cancer cells. It belongs to a group of drugs called immunotherapy. In this trial, it's being tested as an additional treatment before and after standard therapy for brain cancer (glioblastoma). Temozolomide is a chemotherapy medication that is part of the standard treatment (Stupp protocol) for glioblastoma. It works by stopping cancer cells from growing and dividing. Radiation therapy is also part of the standard treatment (Stupp protocol). While not a medication, it uses high-energy rays to target and destroy cancer cells in the brain. Note: The Stupp protocol mentioned in the trial refers to the combination of radiation therapy and temozolomide, which is the current standard treatment for glioblastoma.

What is already known about the treatment

  • Pembrolizumab

    A humanized antibody medication administered through intravenous infusion, primarily used in cancer immunotherapy, including the treatment of glioblastoma multiforme (GBM). This medication works by blocking the PD-1 protein on T cells, which helps the immune system recognize and attack cancer cells more effectively. As part of the immune checkpoint inhibitor class of drugs, Pembrolizumab is being studied in combination with standard chemoradiotherapy (Stupp protocol) for newly diagnosed GBM patients, representing a promising approach in neoadjuvant and adjuvant treatment settings. The medication has shown significant potential in various cancer treatments and continues to be investigated in clinical trials to expand its therapeutic applications.

  • Temozolomide

    An oral chemotherapy medication that is part of the standard treatment (Stupp protocol) for glioblastoma multiforme. This alkylating agent works by damaging the DNA of cancer cells, preventing them from dividing and ultimately leading to their death. Temozolomide is typically administered daily during radiation therapy and then in a cyclic schedule afterward, representing a cornerstone of GBM treatment. The medication can cross the blood-brain barrier effectively, making it particularly valuable for treating brain tumors.

Investigated diseases

Glioblastoma Multiforme - A primary brain tumor that develops from glial cells in the brain. This aggressive tumor forms in the supportive tissue of the brain and typically appears in the cerebral hemispheres. The tumor grows rapidly and can spread throughout brain tissue, creating pressure within the skull. Glioblastoma can cause symptoms such as headaches, nausea, seizures, and changes in behavior or memory. The condition may also affect physical function, depending on which part of the brain is involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517535-52-00Protocol code2019/ABM/01/00062Estimated enrolment36 patientsSponsorAgencja Badań Medycznych

sourced from the EU Clinical Trials Register and site verification

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