Clinical Trials for Glioma: Ongoing Research and Treatment Options
There are currently 20 ongoing clinical trials investigating new treatments for glioma, a type of brain tumor that originates from glial cells in the brain and spinal cord. These studies are testing various medications including targeted therapies, immunotherapies, chemotherapy combinations, and imaging agents across multiple countries in Europe. Trials are available for different glioma grades and subtypes, including high-grade glioma, low-grade glioma, glioblastoma, and diffuse intrinsic pontine glioma, with research sites located in countries such as France, Germany, Italy, Spain, Netherlands, Belgium, Denmark, Poland, Norway, Austria, Romania, and Czechia.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- Study of FG001 for Detecting Meningioma or Low-Grade Glioma in Patients Undergoing Neurosurgery
- Study on Using [68Ga]NOTA-AE105 to Visualize and Differentiate Gliomas in Patients
- France
- Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy
- Study on Fluorodopa (18F) for Diagnosing Low-Grade Glioma in Patients Without MRI Contrast Enhancement
- Study on the Safety and Effectiveness of Vorasidenib and Temozolomide for Patients with IDH1 or IDH2 Mutant Glioma
- Study Comparing Trametinib and Vinblastine for Children and Young Adults with Newly Diagnosed Low-Grade Glioma with Wild-Type BRAF Gene
- Study on Quality of Life and Brain Function in Patients with Diffuse Low-Grade Gliomas Treated with Temozolomide
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- Study of Lenvatinib for Children and Young Adults with Relapsed or Refractory Solid Tumors, Including High Grade Glioma and Rhabdomyosarcoma
- Study of Nivolumab with Chemotherapy for Children and Teenagers with Refractory or Relapsing Solid Tumors or Lymphoma
- Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation
- Germany
- Study of Larotrectinib and Drug Combination for Children with Newly Diagnosed High-Grade Glioma with NTRK Fusion
- Study of Temozolomide and Lomustine Followed by Radiotherapy versus Standard Treatment in Patients with Newly Diagnosed Grade 2 or 3 Glioma
- Study on the Safety and Effectiveness of Vorasidenib and Temozolomide for Patients with IDH1 or IDH2 Mutant Glioma
- Study of L19TNF (onfekafusp alfa) with temozolomide chemoradiotherapy for newly diagnosed glioblastoma patients
- Study of L19TNF and Lomustine for Patients with Recurrent or Progressive Glioblastoma
- Study Comparing Fluciclovine (18F) and Fluoroethyltyrosine F-18 PET Scans in Patients with New or Recurrent Brain Tumors and Brain Metastases
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation
- Italy
- Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy
- Study on the Safety and Effectiveness of Vorasidenib and Temozolomide for Patients with IDH1 or IDH2 Mutant Glioma
- Study of L19TNF (onfekafusp alfa) with temozolomide chemoradiotherapy for newly diagnosed glioblastoma patients
- Study of L19TNF and Lomustine for Patients with Recurrent or Progressive Glioblastoma
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- Study of Lenvatinib for Children and Young Adults with Relapsed or Refractory Solid Tumors, Including High Grade Glioma and Rhabdomyosarcoma
- Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation
- Netherlands
- Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy
- Study on the Safety and Effectiveness of Vorasidenib and Temozolomide for Patients with IDH1 or IDH2 Mutant Glioma
- Study on Bevacizumab and Dexamethasone for Treating Brain Radiation Damage in Patients with High-Grade Glioma or Brain Metastases
- Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation
- Norway
- Poland
- Romania
- Spain
- Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy
- Study on the Safety and Effectiveness of Vorasidenib and Temozolomide for Patients with IDH1 or IDH2 Mutant Glioma
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- Study of Lenvatinib for Children and Young Adults with Relapsed or Refractory Solid Tumors, Including High Grade Glioma and Rhabdomyosarcoma
- Study of Vorasidenib for Patients with Residual or Recurrent Grade 2 Glioma with IDH1 or IDH2 Mutation
Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy
This trial is testing a combination treatment for children and young adults who have been newly diagnosed with high-grade glioma and have already completed radiotherapy. The study compares the use of abemaciclib combined with temozolomide against temozolomide used alone.
Who can participate: Patients must have high-grade glioma confirmed by diagnosis, have completed radiotherapy (with or without temozolomide), and have recovered from major side effects of previous treatments. Participants must be able to swallow medications or have a feeding tube and be willing to undergo frequent lab tests and tumor imaging.
Who cannot participate: Patients without a confirmed high-grade glioma diagnosis, those who haven’t completed radiotherapy, individuals outside the specified age range, those unable to take the study medications, or members of vulnerable populations not included in the study design are excluded.
What the study investigates: The trial evaluates whether adding abemaciclib to standard temozolomide chemotherapy can improve outcomes for patients after radiotherapy. Researchers monitor participants through regular check-ups, lab tests, and imaging to assess treatment effectiveness and any side effects.
Investigational drugs: Abemaciclib is an oral medication being tested to see if it enhances the effectiveness of standard chemotherapy. It works by inhibiting proteins involved in cell division, potentially slowing cancer cell growth. Temozolomide is a chemotherapy drug that interferes with cancer cell DNA to prevent their multiplication.
Study of Larotrectinib and Drug Combination for Children with Newly Diagnosed High-Grade Glioma with NTRK Fusion
This study investigates larotrectinib treatment for young children with newly diagnosed high-grade glioma that has a specific genetic change called NTRK fusion. The trial evaluates both larotrectinib alone and in combination with chemotherapy drugs.
Who can participate: Eligible patients must be 21 years old or younger with newly diagnosed high-grade glioma (including diffuse intrinsic pontine glioma) confirmed to have NTRK fusion. Participants must have adequate organ function, good performance status, and have not received previous anti-cancer chemotherapy beyond surgery.
Who cannot participate: Patients without newly diagnosed high-grade glioma with NTRK fusion, those outside the age range, individuals unable to safely receive the study medication, or those not meeting health criteria are excluded.
What the study investigates: The trial assesses how well larotrectinib controls disease after two treatment cycles and evaluates its safety when used alone and in combination with chemotherapy drugs including carboplatin, methotrexate, vincristine, cyclophosphamide, and etoposide.
Investigational drugs: Larotrectinib is an oral medication that targets tumors with NTRK gene fusions. It works by inhibiting TRK proteins involved in cancer cell growth and survival, representing a form of targeted therapy.
Study of Temozolomide and Lomustine Followed by Radiotherapy versus Standard Treatment in Patients with Newly Diagnosed Grade 2 or 3 Glioma
This trial compares two treatment approaches for adults with newly diagnosed grade 2 or 3 glioma that has a specific genetic characteristic called 1p/19q co-deletion.
Who can participate: Patients must be at least 18 years old with a confirmed grade 2 or 3 glioma, adequate organ function, proper surgical site healing, and an MRI performed within 72 hours after surgery. The tumor must have an IDH mutation and 1p/19q co-deletion. Participants must have a performance score of 60% or higher and life expectancy greater than 6 months.
Who cannot participate: Individuals who have received previous chemotherapy or brain radiation, those with other cancers requiring immediate treatment, severe organ disease, pregnancy, inability to undergo MRI, uncontrolled seizures, active infections, or allergies to study medications are excluded.
What the study investigates: The study evaluates whether combining temozolomide and lomustine chemotherapy before radiotherapy provides better outcomes than starting with radiotherapy followed by PCV chemotherapy. Researchers monitor brain function, quality of life, and survival.
Investigational drugs: Temozolomide and lomustine are oral chemotherapy medications that damage cancer cell DNA. Procarbazine is another oral chemotherapy drug, while vincristine is given intravenously. All work by interfering with cancer cell growth through different mechanisms.
Study on Fluorodopa (18F) for Diagnosing Low-Grade Glioma in Patients Without MRI Contrast Enhancement
This trial explores using a special imaging agent called 18F-FDOPA to help identify more aggressive forms of low-grade glioma that don’t show up well on regular MRI scans.
Who can participate: Patients must be between 18 and 75 years old with a suspected low-grade glioma that doesn’t show contrast on MRI. They must have good general health (WHO condition score of 2 or less), an MRI performed within 3 weeks before joining, and have biopsy or surgery planned within 6 months of the PET scan.
Who cannot participate: Patients with previous brain tumor treatments, severe medical conditions that could interfere, pregnancy or breastfeeding, inability to undergo PET scans, allergies to scan substances, participation in other trials, substance abuse history, or inability to provide informed consent are excluded.
What the study investigates: The trial evaluates how well 18F-FDOPA PET scanning can identify tumor characteristics and help determine tumor aggressiveness, comparing scan results with tissue samples obtained from biopsy or surgery.
Investigational drugs: 18F-FDOPA is a radiopharmaceutical imaging agent given by injection that helps visualize brain tumors during PET scans by mimicking natural brain substances and highlighting areas of abnormal cell activity.
Study on the Safety and Effectiveness of Sirolimus for Treating High-Grade Glioma in Children
This study investigates whether rapamycin (sirolimus) can safely and effectively treat high-grade glioma in children by targeting specific pathways involved in tumor growth.
Who can participate: Children between 3 and 18 years old with confirmed WHO grade III or IV glioma can participate. Parents or legal guardians must provide informed consent (patients over 13 must also consent). Female patients of reproductive age must have negative pregnancy tests and agree to use effective birth control.
Who cannot participate: Patients without high-grade glioma diagnosis, those outside the age range, individuals unable to follow study procedures, those with interfering medical conditions, current participation in other trials, recent surgeries, pregnancy or breastfeeding, medication allergies, or certain medical history are excluded.
What the study investigates: The trial assesses the safety, tolerability, and effectiveness of rapamycin oral solution in treating childhood high-grade glioma. Researchers monitor overall survival, event-free survival, progression-free survival, and response rates at various intervals up to 5 years.
Investigational drugs: Rapamycin (sirolimus) is an oral medication that inhibits the mTOR protein involved in cell growth. Originally used as an immunosuppressant, it’s being studied for potential benefits in treating brain tumors associated with mTOR pathway activation.
Study on the Safety and Effectiveness of Vorasidenib and Temozolomide for Patients with IDH1 or IDH2 Mutant Glioma
This trial tests combining vorasidenib with temozolomide chemotherapy in patients with gliomas that have specific IDH1 or IDH2 genetic mutations.
Who can participate: Patients must be at least 18 years old, weigh at least 40 kg, and have confirmed IDH-mutant glioma with specific genetic characteristics. Requirements include good liver, kidney, and bone marrow function, controlled blood pressure, recovery from previous treatment side effects, and expected survival of at least 3 months. Female participants of childbearing potential must have negative pregnancy tests.
Who cannot participate: Patients with other cancers, recent heart problems, uncontrolled high blood pressure, pregnancy or breastfeeding, active infections requiring antibiotics, recent investigational drug use, allergic reactions to similar drugs, absorption problems, or severe organ disease are excluded.
What the study investigates: The study evaluates the safety and effectiveness of combining vorasidenib with temozolomide, conducting initial dose-finding before assessing how well the combination controls tumor growth and improves survival.
Investigational drugs: Vorasidenib is an oral targeted therapy being tested for treating IDH-mutant gliomas. It works by targeting specific mutations in tumor cells. Temozolomide is an established chemotherapy drug that damages cancer cell DNA to stop their growth.
Study Comparing Trametinib and Vinblastine for Children and Young Adults with Newly Diagnosed Low-Grade Glioma with Wild-Type BRAF Gene
This study compares a new daily oral medication (trametinib) with standard weekly intravenous treatment (vinblastine) for young patients with low-grade glioma that doesn’t have BRAF mutation.
Who can participate: Patients between 1 month and 25 years old with confirmed grade 1 glioma, mixed glio-neuronal tumors, or pleomorphic xanthoastrocytoma requiring post-surgery treatment can participate. They must have adequate organ function, good performance status (at least 50%), no previous anti-cancer chemotherapy, and tumors without BRAFv600 mutation. The study requires informed consent from patients or guardians.
Who cannot participate: Patients with different tumor types, NF1 genetic condition, BRAF gene changes, those outside the age range, inability to follow procedures, interfering medical conditions, pregnancy or breastfeeding, current trial participation, recent treatments, or allergies to study medications are excluded.
What the study investigates: The trial evaluates whether daily oral trametinib is better than weekly intravenous vinblastine in managing disease over 18 months, with 72 weeks of treatment and ongoing monitoring for up to three years.
Investigational drugs: Trametinib is an oral MEK inhibitor being tested for improved treatment outcomes. Vinblastine is standard intravenous chemotherapy that interferes with cell division. Both aim to control tumor growth through different mechanisms.
Study of FG001 for Detecting Meningioma or Low-Grade Glioma in Patients Undergoing Neurosurgery
This trial investigates using FG001, an optical imaging agent, to help surgeons better visualize and locate brain tumors during surgery.
Who can participate: Patients must be 18 years or older with primary brain tumors (meningioma or presumed low-grade glioma) visible on MRI, scheduled for neurosurgery to remove cancer tissue. They must be able to understand study information and provide written consent, with women of childbearing potential agreeing to use reliable birth control during and for 30 days after the study.
Who cannot participate: Patients without meningioma or glioma diagnosis, those outside the age range, or members of vulnerable populations are excluded.
What the study investigates: The study evaluates how effectively FG001 highlights tumor tissue during surgery, making it easier for surgeons to locate and remove tumors accurately. Researchers monitor safety and compare imaging results with tissue analysis.
Investigational drugs: FG001 is an optical imaging agent given as a single intravenous dose before surgery to enhance tumor visualization, helping surgeons identify and remove meningiomas and low-grade gliomas more precisely.
Study of L19TNF (onfekafusp alfa) with temozolomide chemoradiotherapy for newly diagnosed glioblastoma patients
This study evaluates combining L19TNF (Fibromun) with standard temozolomide chemotherapy and radiation therapy for newly diagnosed glioblastoma patients.
Who can participate: Patients must be 18 years or older with newly diagnosed glioblastoma confirmed through tissue examination and a Karnofsky Performance Score of 70% or higher. They must test negative for HIV and hepatitis, with women of childbearing potential having negative pregnancy tests and agreeing to use effective birth control. Participants must be willing to attend scheduled visits, follow treatment plans, and complete laboratory tests.
Who cannot participate: Patients under 18 or over 70 years, those with previous brain tumor treatments, other cancers, severe organ problems, uncontrolled blood pressure, active infections, pregnancy or breastfeeding, allergies to similar treatments, inability to undergo MRI, recent trial participation, mental conditions affecting consent, autoimmune diseases, recent surgery, or interfering medications are excluded.
What the study investigates: The trial assesses whether adding L19TNF to standard treatment is safe and effective, with regular monitoring through brain scans, blood tests, and health assessments over 12 months to evaluate treatment response and side effects.
Investigational drugs: L19TNF is an experimental antibody-cytokine fusion protein given intravenously that targets tumor tissues. Temozolomide is standard oral chemotherapy that damages cancer cell DNA. Both are combined with radiation therapy in this study.
Study of L19TNF and Lomustine for Patients with Recurrent or Progressive Glioblastoma
This trial tests combining L19TNF with lomustine chemotherapy for patients whose glioblastoma has returned or worsened after initial treatment.
Who can participate: Patients must be 18 or older, willing to attend visits and follow treatment plans, with confirmed glioblastoma progression according to 2021 WHO classification and RANO criteria. They need known MGMT promoter status, Karnofsky Performance Status of 60% or higher, and negative tests for HIV, HBV, and HCV. Female participants must have negative pregnancy tests and agree to contraception for 6 months after treatment, while males must use two contraception methods during the study and for 6 months after.
Who cannot participate: Patients without glioblastoma diagnosis, those outside the age range, vulnerable populations, inability to follow procedures, interfering medical conditions, pregnancy or breastfeeding, recent surgeries, current trial participation, medication allergies, or severe medical history are excluded.
What the study investigates: The study determines the best dose combination of L19TNF and lomustine for managing recurrent or progressive glioblastoma, monitoring patients through regular assessments including imaging, blood tests, and safety evaluations.
Investigational drugs: L19TNF is an immunotherapy agent given intravenously that helps the immune system attack cancer cells by targeting specific proteins. Lomustine is oral chemotherapy that interferes with cancer cell DNA to prevent growth and division.
Summary
The 20 ongoing clinical trials for glioma represent diverse research efforts across Europe, with notable concentration of studies in France, Germany, Italy, and Spain. Multiple trials focus on pediatric populations, reflecting the significant burden of these tumors in children and young adults.
Several trials investigate targeted therapies for specific genetic subtypes, particularly IDH-mutant gliomas, with vorasidenib appearing in multiple studies. Immunotherapy approaches, including checkpoint inhibitors like nivolumab and novel agents like L19TNF, represent another major research direction. Combination therapies pairing new agents with established chemotherapy drugs such as temozolomide feature prominently.
Imaging studies using novel tracers like 18F-FDOPA, 68Ga-NOTA-AE105, and 18F-Fluciclovine aim to improve diagnostic accuracy and treatment monitoring. The research spans various disease stages from newly diagnosed to recurrent disease, and different tumor grades from low-grade to aggressive glioblastoma.
These trials reflect the complexity of treating gliomas and the ongoing effort to develop more effective, targeted approaches based on tumor genetics and biology. Patients interested in participating should discuss eligibility and suitability with their healthcare providers.
