Clinical Trials for Glioblastoma Multiforme
Glioblastoma multiforme is an aggressive form of brain cancer that originates from glial cells in the brain. Currently, there are 10 ongoing clinical trials studying various treatment approaches for both newly diagnosed and recurrent glioblastoma, spanning across multiple European countries including Italy, Denmark, France, Norway, Lithuania, Estonia, Latvia, Hungary, Sweden, Belgium, and Spain. These trials are investigating diverse treatment strategies including immunotherapy, targeted medications, cell-based therapies, and novel combinations of existing treatments.
Clinical trial locations
- Belgium
- Denmark
- Estonia
- France
- Hungary
- Italy
- Latvia
- Lithuania
- Norway
- Spain
- Sweden
Long-term safety study of Temferon (modified stem cells with interferon-α2) in patients previously treated for glioblastoma multiforme
This study focuses on the long-term safety of Temferon, an innovative cell therapy for patients who have previously received treatment for this aggressive brain cancer. Temferon involves taking the patient’s own blood stem cells, modifying them in a laboratory to produce interferon alpha-2 (a substance that helps fight cancer), and then returning them to the patient through an intravenous infusion.
Inclusion criteria: Participants must be at least 18 years old and have previously participated in the TEM-GBM_001 study, completing all follow-up visits. They must have received Temferon treatment and be willing to provide written informed consent and follow all study procedures through April 30, 2027.
Exclusion criteria: The study excludes individuals under 18 or over 65 years old, pregnant or breastfeeding women, and those with a history of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ). Patients with active or chronic infections including HIV, Hepatitis B, or Hepatitis C, severe kidney or liver problems, heart conditions, uncontrolled high blood pressure, autoimmune diseases, or mental health conditions affecting consent ability cannot participate. Those currently in other clinical trials, with known allergies to study treatment components, life expectancy less than 3 months, inability to undergo MRI scans, or history of substance abuse in the past 2 years are also excluded.
Focus: The trial monitors long-term safety of Temferon through regular check-ups, blood tests to check for changes in white blood cells, clinical examinations, and brain imaging. Researchers will monitor for any signs of blood disorders or changes in the immune system, assess neurological health, and document any infections or unexpected health changes. The study evaluates whether patients’ conditions are stable, improving, or changing, and tracks overall health and survival.
Investigational drugs: Temferon uses the patient’s own CD34+ blood stem cells modified with a lentiviral vector to produce interferon-α2, a protein that boosts the immune system and potentially slows tumor growth. The modified cells are given back to the patient to deliver targeted treatment directly to the tumor area.
MRI Study with Hyperpolarized Pyruvate for Patients with Glioblastoma
This trial uses an advanced MRI imaging technique with a special substance called hyperpolarized pyruvate to create clearer images of the brain. This helps researchers see changes in brain tissue related to the tumor and its treatment, providing new insights into the tumor’s behavior and treatment effects.
Inclusion criteria: Patients must have a newly diagnosed high-grade glioma (grade 3 or 4) and be scheduled to receive radiotherapy. They must be at least 18 years old with a WHO performance status of 0-2, meaning they can perform daily activities with varying levels of capability. Women of child-bearing age must have a negative pregnancy test and use safe and highly effective birth control during the study. Patients must be able to speak Danish and willing to follow study requirements after giving informed consent.
Exclusion criteria: Patients with any other type of cancer besides glioblastoma, those not within the specified age range, or those who are part of a vulnerable population cannot participate.
Focus: The study involves injecting hyperpolarized pyruvate intravenously before performing MRI scans to observe how the substance moves through the brain and converts into other compounds. This helps assess perfusion, uptake, and conversion in both normal and tumor brain tissue. Follow-up assessments monitor changes over time, including perfusion, microvascular diffusion, and disease progression. The study will conclude by December 31, 2025, with data analyzed to understand treatment impact on progression-free survival and overall survival.
Investigational drugs: Hyperpolarized pyruvate is used as a contrast agent during MRI scans to enhance imaging and detect metabolic changes in brain tissue associated with tumors or therapy effects. It works by altering the magnetic properties of pyruvate, a naturally occurring molecule in the body.
Study on Early Temozolomide Treatment for Adults with Glioblastoma
This trial evaluates whether starting treatment with temozolomide earlier than usual can improve overall survival. Temozolomide is an oral chemotherapy drug that works by slowing or stopping cancer cell growth. The study begins treatment within 15 days after surgery or biopsy, earlier than the standard start time, and continues for a maximum of 10 months.
Inclusion criteria: Patients must be 18 years or older with written informed consent and coverage by French or Belgian Social Security. They must have a histologically confirmed new glioblastoma diagnosis, with the time between first surgery or biopsy and planned treatment start being 14 days or less (ideally within 7 days). A Karnofsky performance status of 60% or higher is required, along with adequate biological functions (sufficient white blood cells, platelets, normal kidney and liver function). Previous treatment side effects should be mild (Grade 1 or less), except for hair loss, nausea, vomiting, and neurological symptoms. Females of child-bearing age must have a negative pregnancy test, and all sexually active patients must agree to use effective birth control during the study and for 6 months after. Standard radiation therapy must be possible, and the time between first surgery/biopsy and planned radiation start should be less than 43 days.
Exclusion criteria: Patients with a different type of brain tumor other than a de novo glioblastoma, those not adults (under 18), those unable to follow study procedures or take medication as required, those with other serious health conditions interfering with the study, pregnant or breastfeeding patients, those participating in another clinical trial simultaneously, or those who have had previous treatment for glioblastoma are excluded.
Focus: Following informed consent and eligibility confirmation, patients begin early treatment with temozolomide according to the study protocol, combined with standard radiation therapy (60 Gy in 30 fractions). The study monitors overall survival from randomization until study end or death, tracks adverse events graded by severity, and assesses progression-free survival and quality-adjusted time without symptoms. The study is estimated to end by May 2025.
Investigational drugs: Temozolomide is an oral chemotherapy agent that damages cancer cell DNA, preventing them from dividing and growing. It is classified as an alkylating agent.
Study on Gemcitabine for Patients with Recurrent Glioblastoma
This trial focuses on recurrent cases that have returned after treatment, using an Individualized Systems Medicine approach. The study tests tumor cells with various drugs to find the most effective treatment for each patient’s specific cancer, targeting cancer stem cells believed responsible for tumor growth and recurrence.
Inclusion criteria: Participants must have histologically verified glioblastoma, be ambulatory with an ECOG performance status of 0-1 (able to walk and carry out daily activities without help or with minimal symptoms), be 18 to 70 years of age, have adequate bone marrow, liver, and heart function, and have signed informed consent according to guidelines and regulations.
Exclusion criteria: Patients without recurrent glioblastoma, those not within the specified age range (young adults and adults), or those who are part of a vulnerable population cannot participate.
Focus: After providing signed informed consent and meeting eligibility criteria (age 18-70, confirmed recurrent glioblastoma, ability to perform daily activities with minimal assistance), patients undergo initial assessment of overall health, bone marrow, liver, and heart function. A personalized treatment plan is developed based on high-throughput drug screening of tumor cells. Gemcitabine is administered as an infusion directly into the bloodstream, with dosage and frequency determined by the healthcare team. Regular monitoring includes assessments of tumor size, side effects, overall survival, and response to treatment. The study continues until February 28, 2026.
Investigational drugs: Individualized Systems Medicine involves testing different drugs on tumor stem cell cultures taken from each patient’s cancer to find the most effective medication for targeting cancer stem cells, creating a treatment specifically tailored to the patient’s unique cancer profile.
Study on LSTA1 and Temozolomide for Patients with Newly Diagnosed Glioblastoma Multiforme
This trial tests a new treatment called LSTA1, a special type of protein given as a powder for injection directly into the bloodstream. The study compares LSTA1 combined with standard treatment (temozolomide) against temozolomide alone to determine if adding LSTA1 can improve survival rates. The study is conducted in a double-blind manner to ensure unbiased and reliable results.
Inclusion criteria: Participants must be 18 to 75 years old at screening, provide written consent, have good lung function (blood oxygen level at least 60 mm Hg or 92% breathing normal air) and normal heart test results, and use effective birth control methods. They must have a new diagnosis of glioblastoma multiforme confirmed by tissue test according to 2021 WHO guidelines, have undergone tumor removal surgery followed by standard radiation (60Gy/30 fractions) combined with temozolomide for 6 weeks, and have at least 4 weeks recovery from surgery. Patients must be able to have regular MRI scans, have an ECOG Performance Status of 0-2, life expectancy of at least 3 months, and can take or continue corticosteroids on stable or decreasing doses for at least 14 days before study start. Healthy organs and bone marrow function are required.
Exclusion criteria: Patients with a different type of brain tumor, those not newly diagnosed, those not within the specified age range, those unable to follow study procedures or take medication as required, those with other serious health conditions interfering with treatment or outcomes, pregnant or breastfeeding patients, those who participated in another clinical trial recently, those with allergies or adverse reactions to study medication or similar drugs, and those unable to provide informed consent are excluded.
Focus: After meeting eligibility criteria and providing written consent, patients are randomly assigned to receive either LSTA1 in combination with temozolomide or a placebo with temozolomide. LSTA1 is administered through direct intravenous injection or placebo depending on group assignment, while temozolomide is taken orally as 100 mg hard capsules according to the study protocol. Regular medical assessments monitor health and response to treatment, including serial MRIs to evaluate tumor status. The study tracks overall survival and progression-free survival as primary and secondary endpoints, estimated to conclude by December 31, 2026.
Investigational drugs: LSTA1 is an investigational medication being studied to potentially improve outcomes when combined with temozolomide. Temozolomide is the standard chemotherapy medication that slows or stops cancer cell growth in the brain.
Study on the Effects of Dendritic Cell Immunotherapy and Temozolomide in Patients with Glioblastoma
This trial tests a new cell-based immune therapy called Autologous cancer stem cell mRNA transfected dendritic cells (DEN-STEM). This treatment uses the patient’s own cells to create a vaccine targeting cancer stem cells, which play a key role in cancer growth and spread. The treatment is given as an injection under the skin and compared with standard therapy combining radiation and chemotherapy.
Inclusion criteria: Patients must be at least 18 and less than 70 years of age, able to walk and perform daily activities with ECOG performance status of 0 or 1. They must have confirmed glioblastoma that is IDH wild type with a non-methylated MGMT-gene promotor, be a candidate for combined radiation therapy and chemotherapy (Stupps Regimen), and have enough tumor tissue available for vaccine production. A postoperative MRI must show a tumor remnant less than 1 cubic centimeter or less than 10% of the original tumor size. Normal organ function as shown by lab tests is required, along with negative tests for HIV, HBV, HCV, and Treponema pallidum. Signed informed consent and agreement to cooperate with treatment and follow-up according to international and local regulations are necessary.
Exclusion criteria: Patients not diagnosed with glioblastoma, those younger than 18 years old, or those who are part of a vulnerable population cannot participate.
Focus: After eligibility confirmation and signed informed consent, initial assessment includes postoperative MRI to evaluate the tumor remnant (must be less than 1 cm³ or less than 10% of original volume). Patients receive standard Stupp’s Regimen therapy (combined radiation and chemotherapy) to prepare the body for immunotherapy. Tumor tissue is used to produce a vaccine targeting cancer stem cells. Immunotherapy involves administering autologous cancer stem cell mRNA transfected dendritic cells through intradermal injection. Progression-free survival is monitored from first surgery to first certain tumor progress, with MRI evaluations at vaccination start, week 25, and every 3 months thereafter. The study concludes by December 31, 2026.
Investigational drugs: Dendritic Cell Immunotherapy uses the patient’s own immune cells to fight cancer, designed to target cancer stem cells and help the immune system recognize and attack these cells more effectively.
Study on How Bevacizumab Affects the Immune System in Patients with Glioblastoma Multiforme
This trial investigates bevacizumab, administered through intravenous infusion, to observe changes in the immune system. Researchers will monitor how long patients remain free from local relapse, how long the disease does not worsen, and overall survival rates. The study also explores blood components such as extracellular vesicles and their content, including micro-RNA, protein, and free DNA-RNA fragments.
Inclusion criteria: Patients must have a diagnosis of glioblastoma multiforme. Those without recurrent glioblastoma who are before receiving radiotherapy and temozolomide therapy can participate, as can those with recurrent glioblastoma who have already had surgery, radiotherapy, and temozolomide therapy if it is appropriate to start bevacizumab therapy. Patients with known relapse already receiving bevacizumab therapy are eligible. Both male and female patients aged 18 to 64 years can participate.
Exclusion criteria: Patients with any other serious medical conditions interfering with the study, those currently participating in another clinical trial, those who had recent surgery or planning surgery during the study, pregnant or breastfeeding patients, those with known allergy to bevacizumab or its components, uncontrolled high blood pressure, history of bleeding disorders, stroke or heart attack within the last 6 months, active infection requiring treatment, or history of drug or alcohol abuse are excluded.
Focus: Upon joining, patients are informed about the study purpose and procedures. Initial assessment includes physical examinations and laboratory tests to ensure eligibility. Bevacizumab is administered through intravenous infusion at 25 mg/ml, with dosage and frequency determined by the study team. Throughout the study, regular check-ups and tests monitor immune system changes and disease progression. The study is expected to conclude by December 31, 2029, with final assessment evaluating overall outcomes and observed changes.
Investigational drugs: Bevacizumab blocks a protein called vascular endothelial growth factor (VEGF), which helps tumors form new blood vessels. By inhibiting this protein, bevacizumab can slow tumor growth by cutting off its blood supply.
Study on the Effectiveness of Valganciclovir for Patients with Glioblastoma
This trial tests valganciclovir, an anti-viral medication, as an additional treatment alongside standard therapy. The study compares outcomes of patients receiving valganciclovir with those receiving a placebo to evaluate whether it can help patients live longer. Participants continue receiving standard treatment, typically including radiation therapy and temozolomide.
Inclusion criteria: Patients must be 18 years or older, start their first dose within 10 weeks after surgery, have a newly diagnosed glioblastoma with no more than 1 cm3 remaining tumor as shown by post-surgery scan, be eligible for standard treatment (radiation therapy and temozolomide), have information available about MGMT promoter methylation status, have a Karnofsky Performance Status of 70 or higher and ECOG/WHO score of 2 or lower, provide written informed consent, and be cooperative and able to complete all study procedures. Females of child-bearing age must have negative pregnancy test at study start and agree to use highly effective birth control during the study and for 6 months after the last dose. Men are recommended to use condoms with female partners who can become pregnant during the study and for 6 months after treatment.
Exclusion criteria: Patients with remaining tumor larger than 1 cm3 after surgery, those not newly diagnosed with glioblastoma, those not receiving standard therapy, those unable to take valganciclovir, or those who are part of a vulnerable population (such as those unable to give consent) are excluded.
Focus: Upon joining, written informed consent is required. Initial assessment confirms eligibility (age 18 or older, newly diagnosed glioblastoma, meets specific health criteria). Patients receive either valganciclovir or placebo orally, with dosage and frequency determined by the study team, as an add-on to standard therapy (radiation therapy combined with temozolomide). Regular monitoring includes monthly pregnancy tests for females of child-bearing age due to the potential for birth defects. Follow-up visits assess health and treatment effectiveness. The study concludes when the last participant has been followed for 30 months, measuring overall survival from surgery until study end or discontinuation.
Investigational drugs: Valganciclovir is an anti-viral medication administered orally, being studied to determine if it can help improve overall survival by reducing remaining tumor size after surgery when used alongside standard treatment.
Study on the Safety and Effectiveness of Nivolumab, Ipilimumab, and Myeloid Dendritic Cells for Patients with Recurrent Glioblastoma After Surgery
This trial uses two medications—ipilimumab (injected directly into the tumor area) and nivolumab (given through intravenous infusion)—along with a special cell therapy involving CD1c+/CD141+ myeloid dendritic cells taken from the patient’s own blood. The study assesses the safety and anti-tumor activity of these treatments when used together after surgical tumor removal.
Inclusion criteria: Participants must have signed written consent, have ECOG performance status score of 0, 1, or 2, have at least 4 months since last radiation therapy (unless brain MRI shows tumor progression), have well-functioning organs as shown by specific blood tests, not have been treated with nivolumab, ipilimumab, or therapies targeting CTLA-4 or PD-1/-L1 before, not have digestive system issues affecting medication intake or absorption, have controlled blood pressure within normal limits, not be participating in another clinical trial or require ongoing blood-thinning medication, not have active autoimmune disease (except certain conditions like type I diabetes or skin disorders not needing systemic treatment), not be taking high doses of steroids or immune-suppressing medications, be 18 years or older, have good veins for leukapheresis (collecting white blood cells), not have uncontrolled seizures, not have had heart attack or serious heart issues in the past year, not have HIV or AIDS-related illnesses, not have serious medical conditions or infections affecting treatment ability, not have had other cancers (except certain types treated successfully with no disease signs for 5 years), not have severe medical or psychiatric conditions making study participation risky, not have dementia or mental issues preventing understanding of study requirements. Women who can have children must have negative pregnancy test and agree to use effective birth control during the study; men must also agree to use effective birth control. For Cohort 5, no issues preventing brain surgery for recurrence; for Cohort 6, recurrent tumor suitable for safe biopsy and resection cavity from previous surgery present. Any previous treatment side effects should be mild or resolved (except hair loss). Patients must be willing to follow study schedule, have confirmed glioblastoma diagnosis with return or progression after previous treatments (surgery, radiation, chemotherapy), have tumor measurable on MRI scan with no significant bleeding inside, not have ventriculo-peritoneal drain, and not have issues preventing certain types of brain scans.
Exclusion criteria: Patients not diagnosed with glioblastoma, those not adults (18 years or older), those who belong to a vulnerable population, those who do not meet other specific health criteria, those who are not able to follow study procedures or take medication as required, those with other serious health conditions interfering with the study or making it unsafe, pregnant or breastfeeding patients, or those participating in another clinical trial simultaneously are excluded.
Focus: The trial begins with surgical removal of the recurrent tumor (biopsy or extensive procedure), followed by ipilimumab injection directly into the tumor site and nivolumab infusion through a vein. Further nivolumab doses are administered through intravenous infusion combined with additional ipilimumab injections into the cavity left by tumor removal, with frequency and dosage determined by trial protocol and individual response. Regular monitoring includes medical check-ups, imaging tests such as MRI, and laboratory tests to assess organ function and detect side effects, ensuring treatment safety and observing anti-tumor effects. The trial concludes with final evaluation of patient condition, assessing overall survival, progression-free survival, and any changes in tumor size or characteristics.
Investigational drugs: Ipilimumab is administered directly into the tumor to enhance the body’s immune response against cancer by blocking a protein that normally keeps immune cells from attacking the body’s own tissues. Nivolumab is given both directly into the tumor and through a vein, enhancing the immune system’s ability to fight cancer by targeting a specific protein that prevents immune cells from attacking cancer cells. Both are immune checkpoint inhibitors. Autologous CD1c(BDCA-1)+/CD141(BDCA-3)+ myDC refers to special immune cells taken from the patient’s own body, modified, and injected back to help stimulate a stronger immune response against the tumor.
Study of Berubicin versus Lomustine in adult patients with recurrent Glioblastoma Multiforme after first-line treatment failure
This study tests a new medication called Berubicin, given through intravenous infusion, comparing it to Lomustine taken as an oral capsule. The trial evaluates how well Berubicin works compared to Lomustine in extending survival time for patients whose tumor has returned after their first treatment. The study is open-label, meaning both doctors and patients know which treatment is being given.
Inclusion criteria: Participants must provide written informed consent and be willing to follow study procedures, be at least 18 years old, have a Karnofsky Performance Score of 60 or higher (able to perform daily activities), have confirmed diagnosis based on tissue examination, have received no more than one previous line of treatment, have recovered from previous treatment side effects to mild level or less, be on stable or decreasing steroids for at least 5 days before brain MRI, have adequate blood cell counts, liver function, and kidney function (white blood cell count ≥ 3,000/microliter, platelet count ≥ 75,000/microliter, hemoglobin ≥ 10 g/dL). Women who can become pregnant must have negative pregnancy test and use effective birth control during study and for 6.25 months after; men must use effective birth control during study and for 3.5 months after. Patients must be free of other cancers for at least 5 years (except successfully treated skin cancer or cervical cancer in situ), and tumor must be located in the upper part of the brain with no spread to the spine or brain fluid.
Exclusion criteria: Prior exposure to berubicin or similar chemotherapy drugs in the same class, active untreated brain metastases, severe heart problems or uncontrolled high blood pressure, significant liver or kidney dysfunction, history of other cancers within the past 5 years (except successfully treated non-melanoma skin cancer), pregnancy or breastfeeding, active serious infections requiring treatment, major surgery within 4 weeks before study start, participation in another clinical trial within 30 days, known allergies to study medications or components, inability to swallow oral medications, severe psychiatric conditions interfering with study participation, life expectancy less than 3 months, immunocompromised status, or use of certain medications that might interact with the study drug are excluded.
Focus: Medical records are reviewed to confirm diagnosis and verify no more than one prior treatment line. Brain MRI scan documents disease progression. Basic laboratory tests check blood counts, liver, and kidney function to ensure eligibility. Patients are randomly assigned to receive either Berubicin (intravenous infusion) or Lomustine (oral capsules). Throughout treatment, regular brain MRI scans monitor response, blood tests monitor health, and doctors assess side effects. After completing treatment, regular check-ups and brain MRI scans continue to monitor disease status until January 2026. Patients must maintain effective birth control during the study and for several months after treatment completion, attend scheduled appointments regularly, and report new symptoms or side effects promptly.
Investigational drugs: Berubicin is a chemotherapy medication given through intravenous infusion, attacking cancer cells to stop them from growing and spreading. It belongs to the anthracycline class and interferes with DNA synthesis in cancer cells. Lomustine is an oral chemotherapy medication in the nitrosourea family that damages cancer cell DNA to prevent them from dividing and growing, serving as a standard comparative treatment.
Summary
The 10 ongoing clinical trials for glioblastoma multiforme span multiple European countries, with notable concentrations in Norway (three trials), and multiple trials in France, Italy, and Spain. The research landscape shows a diverse approach to treatment, ranging from traditional chemotherapy modifications to cutting-edge immunotherapy and personalized medicine strategies.
Several trials focus on immunotherapy approaches, including dendritic cell vaccines, checkpoint inhibitors like nivolumab and ipilimumab, and novel cell-based therapies such as Temferon. There is also significant interest in optimizing existing treatments, with studies examining early temozolomide administration and combination approaches. Advanced imaging techniques using hyperpolarized pyruvate represent an innovative diagnostic direction, while personalized medicine approaches based on individual tumor characteristics are being explored in the Norwegian gemcitabine trial.
The trials address both newly diagnosed and recurrent cases, recognizing the different treatment challenges at each stage. Most studies require participants to be adults (18 years or older) with confirmed diagnoses and adequate organ function. Common exclusion criteria include pregnancy, other active cancers, and severe organ dysfunction. The geographic distribution of these trials across Europe provides patients in many countries access to experimental treatments that may offer hope where standard therapies have proven insufficient.
