New Brain Tumor Clinical Trials: January- March 2024

It can be hard to keep track of new clinical trial opportunities opening across the United States. There are many clinical trials actively enrolling patients. This report provides a summary of the studies that have recently opened or started recruiting (January 1, 2024 – April 9, 2024) for patients with a primary brain tumor*. Follow the hyperlink for each study to learn more and to contact the party responsible for enrolling patients.** 

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• Surgical Pembro +/- Olaparib w TMZ for rGBM
  • A phase II study to evaluate combinations of an immunotherapy and DNA Damage Response Inhibitor drug as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. (Note: NBTS has provided funding for this trial in association with our DNA Damage Response Consortium).
• Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
  • This phase II trial studies how well the drugs vismodegib, GSK2256098, Abemaciclib, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). 
• Clinical Trial of the ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Recurrent Brain Tumors
  • A phase 0/I clinical trial to evaluate the investigational drug, WSD0628, in combination with radiation for patients with recurrent brain tumors.
• Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM (SONOBIRD)
  • The objective of this randomized, pivotal trial is to show that the combination of carboplatin with the SonoCloud-9 ultrasound device will increase efficacy of the drug in patients with recurrent glioblastoma (GBM).

• Sonodynamic Therapy in Patients With Recurrent Glioblastoma (GBM 001)
  • This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent glioblastoma (GBM).
• A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma (GBM)
  • The primary objective of this non-randomized, phase I/II clinical trial is to determine the safety and tolerability of two doses of light in intraoperative photodynamic therapy (PDT) added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 69 with newly diagnosed glioblastoma (GBM).
• Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (GBM)
  • In this phase IIa clinical trial, researchers will implant a novel device with 9 ultrasound emitters, allowing temporary and reversible opening of the blood-brain barrier to maximize brain penetration of drugs that modulate the immune system.
• Surgical Study on Upfront or Recurrent High-Grade Glioma (WHO Grade III and IV) Electrical Activity
  • This phase I trial will test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings.
• Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma
  • The purpose of this trial is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects’ brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.
• Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
  • This phase II trial tests how well the drug erdafitinib works in controlling IDH-wild type (WT) gliomas with FGFR-TACC gene fusion that have returned or that have grown, spread, or gotten worse (progressed).

• PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
  • This phase I/II trial will test an investigational drug (PLX038) in people with tumors of the brain or spinal cord.
• CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/​DIPG in Children and Young Adults
  • A phase I trial of a new immunotherapy called CD200AR-L in combination with the drug imiquimod, and an anti-tumor vaccine called GBM6-AD to treat malignant glioma in children and young adults.

• NEO100 and High-Grade Meningioma
  • A phase II trial to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma, or recurrent high-grade meningioma.
• A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
  • The purpose of this early phase I study is to find out whether a novel imaging method called 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.
• Study of IK-595 in RAS- or RAF-altered Advanced Tumors
  • This is a pilot, phase I trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors – including certain brain cancer patients –  with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit.
• An Open-Label Phase II Study of Nivolumab in Adult Participants With Progressive/​ Recurrent Meningioma
  • This research is a phase II clinical trial, which means it will test the safety and effectiveness of nivolumab alone (Cohort 1) or in combination with ipilimumab (Cohort 2). Both nivolumab and ipilimumab are antibodies (types of human protein) that work to stop tumor cells from growing and multiplying by immunotherapy. Immunotherapy is trying to have the body’s own immune system work against tumor cells.
• Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
  • This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment.
• ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (ACTION)
  • This phase III trial in patients with newly diagnosed H3 K27M-mutant diffuse glioma will assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
• Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma
  • This phase I/II trial studies the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating patients with grade II-III meningioma that has come back (recurrent).
• Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
  • This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery.
• Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma
  • This phase II trial studies the effect of stereotactic radiosurgery and the immunotherapy, pembrolizumab, in treating patients with meningioma that has come back (recurrent). 
• A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
  • This phase I/II trial is studying radiation therapy as a possible treatment for meningioma, or a tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT).
• 68-Ga DOTATATE PET/​MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors (DOMINO-START)
  • This study is to determine the diagnostic utility of a novel form of imaging called 68Ga-DOTATATE PET/MRI in the diagnosis and management of patients with SSTR-positive CNS tumors (focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain, such as small cell carcinoma of the lung), specifically whether 68Ga-DOTATATE PET/MRI demonstrates utility distinguishing between tumor recurrence and post-treatment change. 
• Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) 
  • This is a multi-arm phase II platform-basket screening study designed to test multiple experimental therapies simultaneously in patients with NF2-related schwannomatosis (NF2-SWN, formerly known as neurofibromatosis type 2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas.
• Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers
  • This phase II trial aims to learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.
• Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT (MEMMAT)
  • In this study the investigators will evaluate the use of biweekly intravenous bevacizumab (Avastin) in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal delivery of the drugs etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults.
• Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/​or Refractory Solid and CNS Tumors (AflacST1502)
  • This phase II study aims to determine the efficacy of daily dosing of the drugs sirolimus and celecoxib, with low dose etoposide alternating with cyclophosphamide for pediatric participants with relapsed or refractory tumors.
• HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma
  • This is a Phase I study to evaluate the safety profile of a type of immune therapy called HER2 CAR T cells (short for HER2 chimeric antigen receptor T cells). In addition to looking for side effects, we will study how well this treatment works against a brain tumor called ependymoma that has come back after treatment (recurrent) or has not responded well to treatment (progressive) in children. 
• Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG
  • This is a multicenter trial of the Optune device to examine the feasibility and to describe the device-related toxicity in children with supratentorial high grade glioma (HGG) or ependymoma (Stratum 1) and to examine the feasibility and efficacy of concurrent Optune and standard focal radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum 2).
• A Pilot Study of SurVaxM in Children With Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma, and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
  • This is a multicenter pilot study of SurVaxM (an immunotherapy) for children and young adults with progressive or relapsed medulloblastoma, high-grade glioma, ependymoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG).
• Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma (GBM), Ependymoma, or Medulloblastoma
  • This phase I trial investigates the side effects of brain tumor-specific immune cells (IL13Ralpha2-CAR T cells) in treating patients with leptomeningeal disease from glioblastoma (GBM), ependymoma, or medulloblastoma.
• Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas (DIPG), Hypermutated Brain Tumors, Ependymoma, or Medulloblastoma
  • This phase I trial studies the side effects and best dose of the immunotherapy pembrolizumab and to see how well it works in treating younger patients with high-grade gliomas, diffuse intrinsic pontine gliomas (DIPG), brain tumors with a high number of genetic mutations, ependymoma, or medulloblastoma that have come back (recurrent), progressed, or have not responded to previous treatment (refractory).
• Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
  • Loc3CAR is a phase I clinical trial evaluating the use of autologous B7-H3-CAR T cells for participants 21-years old or younger with primary brain cancers. 
• Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
  • This phase II Pediatric MATCH trial studies how well the drug ensartinib works in treating patients with solid tumors (including brain tumors), non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or do not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). 
• A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
  • This phase Ib/II trial’s purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment.
• A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma (GBM) Patients
  • This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed glioblastoma (GBM) patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed.
• Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
  • This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors (including brain tumors), non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. 
• Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Study
  • This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, and determine if there is a difference in the outcome of the treatment, and most importantly, the patients’ quality of life.
• PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy (PEACH)
  • A phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy.
• Treatment of Relapsed/​Refractory Intracranial Glioma in Patients Under 22 Years of Age
  • A phase I/II trial to assess the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients < 22 years of age.
• Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma (DIPG), Diffuse Midline Glioma (DMG), And Recurrent Or Refractory Central Nervous System Tumors
  • This is a phase I study of central nervous system (CNS) locoregional adoptive therapy with SC-CAR4BRAIN, an autologous CD4+ and CD8+ T cells lentivirally transduced to express combinations of B7-H3, EGFR806, HER2, and IL13-zetakine chimeric antigen receptors (CAR). CAR T cells are delivered via an indwelling catheter into the ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors.
• Guided Meditation During Radiation Therapy for Brain Tumors (Med-RT)
  • This trial seeks to answer the primary question of, “What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions?”
• Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
  • This observational trial evaluates the use of what’s known as an “Ommaya reservoir,” placed during a biopsy in patients with brain tumors. An Ommaya reservoir is a small device that’s implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap, and could help identify biomarkers in patients’s CSF as a promising minimally invasive approach for monitoring tumor growth and response to therapy.
• A Phase II Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With Diffuse Intrinsic Pontine Glioma (DIPG)
  • The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in subjects with diffuse intrinsic pontine glioma (DIPG).
• CONVIVO Endomicroscopy
  • The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating between healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.

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TAGGED WITH: Oligodendroglioma, glioblastoma, Medulloblastoma, astrocytoma, meningioma, DIPG, AT/RT, Clinical trials, Ependymoma, DMG

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