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Study on the Effectiveness of Optune with Temozolomide and Pembrolizumab in Patients with Newly Diagnosed Glioblastoma

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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 called glioblastoma, which is a newly diagnosed condition in the patients participating. The study is testing the effectiveness of a treatment method that combines a medical device called Optune with medications temozolomide and pembrolizumab. Optune is a portable device that uses electric fields, known as Tumor Treating Fields, to target and kill cancer cells in the brain. Temozolomide is a chemotherapy drug taken orally, while pembrolizumab is an immunotherapy drug given through an intravenous infusion. Some participants will receive a placebo instead of pembrolizumab to compare the outcomes.

The purpose of the study is to compare the overall survival of patients receiving the combination of Optune, temozolomide, and pembrolizumab with those receiving Optune, temozolomide, and a placebo. Participants will be randomly assigned to one of these two groups. The study will be conducted over a period of time, with regular monitoring and assessments to track the progress and effects of the treatment. The trial aims to provide valuable information on whether the addition of pembrolizumab to the existing treatment can improve survival rates for patients with newly diagnosed glioblastoma.

Throughout the study, participants will undergo various evaluations to ensure their safety and to gather data on the treatment's effectiveness. The trial will help determine if this combination of treatments can offer a better outcome for patients facing this aggressive form of brain cancer. The study is expected to continue until 2028, with the goal of advancing the understanding and management of glioblastoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    The treatment begins with the use of Optune, a device that delivers Tumor Treating Fields (TTFields) to the brain. This is used in combination with temozolomide, a chemotherapy medication.

    The temozolomide is taken orally at a dose of 150-200 mg per square meter of body surface area daily for 5 days, followed by a 23-day rest period, making a 28-day cycle.

  2. Step 2

    Administration of pembrolizumab or placebo

    In addition to the above treatment, either pembrolizumab or a placebo is administered. Pembrolizumab is given as an intravenous infusion.

    The purpose of this step is to compare the effects of pembrolizumab with a placebo when used alongside Optune and temozolomide.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor the patient's health and the effectiveness of the treatment.

    These assessments include measuring overall survival and progression-free survival, which refers to the length of time during and after treatment that the patient lives with the disease without it getting worse.

  4. Step 4

    Completion of trial

    The trial is expected to continue until October 2028, with regular follow-ups to assess long-term outcomes.

    The primary goal is to determine the overall survival benefit of the treatment combination compared to the use of Optune and temozolomide with a placebo.

Who can join the trial?

11 criteria

  • The participant or their legally acceptable representative must have given documented informed consent to join the study.
  • The participant must be at least 18 years old on the day they provide informed consent.
  • The participant must have a new diagnosis of GBM (Glioblastoma) according to the WHO 2021 Classification.
  • The participant must have recovered from surgery aimed at removing as much of the tumor as possible. This includes complete removal, partial removal, or just a biopsy. The use of Gliadel wafers during surgery is allowed. Gliadel wafers are small implants used to deliver chemotherapy directly to the brain.
  • The participant must have completed standard treatment with radiation therapy (RT) and chemotherapy with temozolomide (TMZ) according to local medical practices.
  • The participant must be able to start the study treatment at least 4 weeks after the last dose of either temozolomide or radiotherapy.
  • The participant must be willing to receive treatment with Optune along with maintenance temozolomide. Optune is a device used to treat brain tumors.
  • The participant must have had tissue samples submitted for MGMT Promoter Methylation testing before being randomly assigned to a treatment group. This test helps determine how the tumor might respond to treatment.
  • The participant must have an ECOG Performance Status of 0 to 1, assessed within 7 days before randomization. This status is a scale used to assess how a disease affects a patient's daily living abilities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The participant must have a life expectancy of at least 3 months.
  • If applicable, the participant must have a stable or decreasing dose of corticosteroids (such as dexamethasone ≤ 2mg) for the last 7 days before being randomly assigned to a treatment group. Corticosteroids are medications used to reduce inflammation and swelling.

Who cannot join the trial?

7 criteria

  • Patients who have not been newly diagnosed with Glioblastoma cannot participate. Glioblastoma is a type of brain cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or who have conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other serious medical conditions that could affect their safety or the study results cannot participate.
  • Patients who are taking certain medications that might interfere with the study treatment cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
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Investigated drugs

  • Optune

    is a device used in the treatment of glioblastoma, a type of brain cancer. It works by delivering electric fields, known as Tumor Treating Fields (TTFields), to the tumor site. These fields can disrupt cancer cell division, potentially slowing down or stopping the growth of the tumor.

  • Temozolomide

    is a chemotherapy medication used to treat certain brain cancers, including glioblastoma. It works by damaging the DNA of cancer cells, which can prevent them from growing and dividing.

  • Pembrolizumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in various types of cancer treatments and works by blocking a specific protein that prevents the immune system from attacking cancer cells.

What is already known about the treatment

  • Optune

    Optune is a medical device used in the treatment of newly diagnosed glioblastoma, a type of brain cancer. It is administered through a wearable cap that delivers low-intensity, alternating electric fields known as Tumor Treating Fields (TTFields) directly to the tumor site. This device is currently recognized in medical literature as a supportive treatment for glioblastoma, often used alongside other therapies. The main therapeutic indication is to improve overall survival in patients with this aggressive cancer. Optune works by disrupting cancer cell division at the molecular level, thereby slowing down tumor growth. It is classified as a non-invasive cancer treatment device.

  • Temozolomide

    Temozolomide is an oral chemotherapy medication used in the treatment of newly diagnosed glioblastoma. It is taken in pill form and is often used in combination with other treatments like Optune. In medical literature, it is well-established as a standard treatment for this type of brain cancer. The main therapeutic indication is to kill cancer cells and reduce tumor size. At the molecular level, temozolomide works by damaging the DNA of cancer cells, which prevents them from multiplying. It is classified as an alkylating agent in pharmacology.

  • Pembrolizumab

    Pembrolizumab is an immunotherapy drug administered through intravenous infusion, used in the treatment of newly diagnosed glioblastoma as part of clinical trials. It is currently being studied for its effectiveness in combination with other treatments like Optune and temozolomide. The main therapeutic indication is to enhance the body's immune response against cancer cells. Pembrolizumab works by blocking a specific protein on immune cells, allowing them to better recognize and attack cancer cells. It is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often leading to increased pressure within the skull. Symptoms can include headaches, nausea, vomiting, and neurological deficits such as weakness or speech difficulties, depending on the tumor's location. As the disease progresses, it can cause more severe neurological impairments and changes in personality or behavior. Glioblastoma is typically diagnosed through imaging studies and biopsy, revealing its characteristic features. The disease is challenging to manage due to its tendency to infiltrate surrounding brain tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513550-30-00Protocol codeEF-41/KEYNOTE D58Estimated enrolment741 patientsSponsorNovocure GmbH

sourced from the EU Clinical Trials Register and site verification

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