[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"who-grade-4-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:who-grade-4-glioma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,68,94,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100550233","phase-2-an-investigational-scan-ga-68-psma-11-petct-for-detection-of-disease-recurrence-or-progression-in-patients-with-glioma-100550233",false,"NCT06444412","An Investigational Scan (Ga-68 PSMA-11 PET\u002FCT) for Detection of Disease Recurrence or Progression in Patients With Glioma","GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* History of World Health Organization (WHO) grade III or IV infiltrating glioma previously treated with first-line chemoradiotherapy.\n* MRI findings compatible with contrast-enhancing recurrent infiltrating glioma.\n* Planned biopsy or resection of suspected disease recurrence.\n* Willing to sign release of information for any radiation and\u002For follow-up records.\n* Ability to provide informed written consent.\n* Ability to provide tissue for mandatory correlative research component.\n\nExclusion Criteria:\n\n* Unable to undergo a PSMA PET\u002FCT scan (e.g. body habitus, claustrophobia).\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential unwilling to employ adequate contraception","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)\u002Fcomputed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET\u002FCT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET\u002FCT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.",[26,27],"WHO Grade 3 Glioma","WHO Grade 4 Glioma","RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2026-01-12",{"date":36,"type":20},"2028-07-31",{"name":38,"class":39},"Mayo Clinic","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100642450","phase-2-study-of-relatlimab-and-nivolumab-opdualag-in-replication-repair-deficient-hgg-and-dipg-100642450","NCT07644312","Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG","Feasibility and Phase 2a Study of Relatlimab and Nivolumab (Opdualag™) in Adolescent and Young Adult Patients Newly Diagnosed With Replication Repair Deficient High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG)","Inclusion Criteria:\n\n* Patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR.\n* Within the United States, patients must weight ≥ 40 kg at the time of enrollment. For all other countries, patients must weight ≥ 30 kg at the time of enrollment.\n\nDiagnosis:\n\n* Patients with newly-diagnosed HGG, including DIPG, are eligible. All patients mut have histologic confirmation from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG must have been confirmed through TarGeT-SCR.\n* All HGGs must be WHO Grade 3 or 4. Note: WHO Grade 2 gliomas with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons are eligible.\n\nDisease Status:\n\n* Patients must be newly diagnosed.\n* Measurable disease is not required.\n* Patients with primary spinal tumors are eligible.\n* Patients should have no evidence of herniation or impending herniation, and no mass effect leading to severe midline shift.\n* Patients with prior malignancy are eligible.\n* Metastatic disease is excluded.\n* Disseminated or multifocal disease: discussion with Study Chairs is required. Patients with multifocal disease who received upfront CSI are not eligible.\n\nDemonstration of DNA replication repair deficiency (RRD) by fulfilling at least 2 of the following criteria:\n\n* Tumor mutational burden greater than or equal to 5 mutations\u002Fmegabase (Intermediate and high TMB)\n* Genetic diagnosis of germline Constitutional Mismatch Repair Deficiency (CMMRD), Lynch Syndrome, or Polymerase-Proofreading Deficiency (PPD)\n* Validated functional genomic assay (e.g. LOGIC) confirming mismatch repair (MMR) deficiency\n* Immunohistochemistry (IHC) demonstrating loss of protein expression of any of the 4 MMR genes\n\nPerformance Level: Karnofsky ≥ 50 for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age\n\nPrior Therapy for HGG:\n\n* Surgery, RT, and\u002For dexamethasone are permissible. Temozolomide administration is highly discouraged with concurrent RT, but permissible. Anti-VEGF treatment used for vasogenic edema or steroid weaning is permitted. No other prior anticancer therapy for HGG will be allowed. Anti-VEGF use is well-established to not impact outcomes in HGG and is not considered as oncologic treatment but rather as a supportive measure to minimize steroid use in this setting. Discussion with Study Chairs is highly recommended.\n* RT requirements: Patients must have received photon or proton focal RT and administered at a standard dose, including:\n* 54 Gy in 30 fractions for DIPG\n* 54-59.4 Gy in 30-33 fractions for other HGG\n* 45-54 Gy for primary spinal cord HGG Note: Variances in RT dose within 10% of standard doses listed above are acceptable.\n* Timing between diagnosis and start of RT: Patients must have started RT \\\u003C 42 calendar days from initial diagnosis.\n* Timing post-RT: The earliest patent can begin protocl treatment is 28 days post-completion of RT. It is recommended treatment should begin within 25 days, however patients must start treatment on TarGeT-F no later than 8 weeks post-completion of RT.\n\nOrgan Function Requirements:\n\n* ANC ≥ 1000\u002Fmm3\n* Platelet count ≥ 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin \\> 8g\u002FdL (may be transfused)\n* Creatinine clearance or radioisotope GFR≥ 70 mL\u002Fmin\u002F1.73 m2 OR serum creatinine based on age\u002Fgender as follows:\n\n  10 to \\\u003C 13 years: 1.2 mg\u002FdL for males and females 13 to \\\u003C 16 years: 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females\n  * 16 years: 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females\n* AST\u002FALT \\\u003C 3 times the ULN. For the purpose of this study, the ULN for ALT and AST is 45 U\u002FL.\n* Ejection fraction greater than or equal to 50% as measured by echocardiogram or multiple-gated acquisition\n* QTc ≤ 480 msec (by Bazett formula)\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.\n* TSH within institutional guidelines for normal range.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients are excluded.\n* Patients with uncontrolled infection.\n* Patients with bone marrow failure syndrome.\n* Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n* Inflammatory bowel disease\n* Moderate to severe pulmonary conditions defined by need for medical intervention and\u002For limiting activities of daily living or shortness of breath with limited exertion.\n* Personal history of pneumonitis.\n* Cardiac conditions.\n* Patients with a history of severe or life-threatening adverse dermatologic reactions such as SJS or toxic epidermal necrolysis, or other severe reactions that have been associated with prior immune checkpoint inhibitor therapy.\n* Active tuberculosis\n* Active autoimmune disease requiring systemic treatment in the past 2 years\n* Chronic HBV infections with active disease\n* Personal known history of HPC who have not completed curative antiviral treatment\n* Personal known history of HIV\n* Receipt of any organ transplantation\n* Treated with other malignancy within 1 year prior to enrollment with the exception of the following: curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and in situ cervical cancer.\n* Receipt of a live or live-attenuated vaccine within 4 weeks prior to enrollment\n* Previous treatment with relatlimab\n* Patients with ongoing or clinically significant illness, medical or psychiatric conditions that, in the investigator's opinion, could affect the safety of the participant, or could impair assessment of the study's results are not eligible.","12 Years","39 Years",{"count":51,"type":20},12,[23],"The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.",[55,56,26,27,57],"High Grade Glioma","Diffuse Intrinsic Pontine Glioma","Replication Repair Deficient","NOT_YET_RECRUITING","2026-06-08",{"date":61,"type":32},"2026-06-12",{"date":63,"type":20},"2027-03-01",{"date":65,"type":20},"2038-03-01",{"name":67,"class":39},"Nationwide Children's Hospital",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":40},"100590232","phase-1-anti-garp-chimeric-antigen-receptor-t-cell-therapy-for-the-treatment-of-recurrent-grade-iii-or-iv-gliomas-100590232","NCT06964737","Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas","A Phase I, Dose-Escalation Trial of Anti-GARP Chimeric Antigen Receptor-T Cell Therapy in Patients With Recurrent High-Grade Glioma Treated at a Single Medical Center","Inclusion Criteria:\n\n* Patients are ≥ 18 years old\n* Capacity to understand and willingness to provide written informed consent\n* Diagnosis or clinical suspicion of recurrent malignant glioma, including:\n\n  * History of high-grade glioma (World Health Organization \\[WHO\\] grade III or IV), or\n  * Prior, histologically-confirmed diagnosis of grade II glioma with new radiographic findings consistent with a high-grade glioma\n* Imaging and\u002For histopathological confirmation of recurrent disease, or verification of \"high risk\" histology confirmed by a biopsy with measurable disease by the Radiologic Assessment in Neuro-Oncology (RANO) criteria\n* Patient has unifocal disease in one hemisphere and is supratentorial. Lesion and edema can not be located in eloquent locations (e.g., brainstem, pre-\u002Fpost-central gyrus, visual cortex) or within 2 gyri of motor strip.\n* If on steroids such as dexamethasone, must be on a low dose (≤ 4mg per day) at the time of treatment, and not at an ascending dosage schedule at time of enrollment\u002Fleukapheresis\n\n  * Prior to apheresis and treatment 1 a 2- week washout should be observed\n* Subjects must not have received bevacizumab therapy and are not planned to start such therapy\n* Karnofsky performance score (KPS) ≥ 60\n* Subject is a surgical candidate for surgery for malignant glioma with the intent of resecting \\>80-90% of the tumor as the ideal treatment option\n* White blood cells (WBC) \\> 4,000 cells\u002FuL\n* Hemoglobin (Hgb) \\> 7 gm\u002FdL\n* Platelets (Plt) \\> 100\u002FdL\n* Serum creatinine ≤ 1.5 x institutional upper limit of normal\n* Liver function tests within 1.5 x institutional upper limit of normal\n* Women of reproductive potential must have a negative pregnancy test within 7 days of study start. All patients of reproductive potential must use a physician-approved contraceptive and refrain from sperm donation for at least two weeks prior, during, and six months after final T cell infusion. Women must refrain from breastfeeding for six months after final T cell infusion\n* Sufficient venous access, to be confirmed prior to apheresis\n* Life expectancy of greater than 12 weeks\n* PI clinical judgement of patients who will likely complete the trial and are able to maintain stable neurologic symptoms during intervention period\n\nExclusion Criteria:\n\n* Patients who have a history of malignancy other than the glioma under investigation in this study, except patients with the following malignancies\u002Ftreatment characteristics, who are eligible at the investigator's discretion:\n\n  * Patients with a history of malignancy that has been treated with curative intent at least 2 years prior to screening and with no evidence of relapse, if no concurrent anti-cancer therapy (except hormonal therapy) is being given\n  * Patients with a history of malignancy with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer\n  * Patients who have prostate cancer with no evidence of metastatic disease and are not on active therapy, except anti-androgen therapy\n* History of autoimmune disease, or other diseases require long-term administration of high-dose steroids \\[\\> 10 mgs\u002Fday\\] or immunosuppressive therapies\n\n  * Research participants who received steroids must have either received their last dose of steroids 7 days or more prior to apheresis or have dosage tapered to \\\u003C 2mg\u002Fkg\u002Fday\n* Patients being treated concurrently (within 14 days prior to study enrollment) with any other investigational agent\n\n  * Examples of other investigational agents that would be exclusionary include supportive care agents\n* Patients receiving anti-cancer agents such as chemotherapy (e.g., temozolomide) must stop treatment 14 days prior to undergoing apheresis and remain off therapy throughout the duration of CAR T therapeutic intervention\n* Patients with active fungal, bacterial, viral, or other infection that requires intravenous antimicrobials\n\n  * Prophylactic antimicrobials are allowed\n  * Patients with active invasive fungal infection should be excluded even if the treatment is oral antimicrobials\n* History of allergy to study products\u002Fdiluents\u002Femulsions\n* Recent history (within last 3 months) of uncontrolled seizures",{"count":76,"type":20},30,[78],"PHASE1","This phase I trial tests the safety, side effects, and best dose of anti-glycoprotein-A repetitions predominant (GARP) chimeric antigen receptor (CAR) T cell therapy and how well it works in treating patients with grade III or IV gliomas that have come back after a period of improvement (recurrent). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as GARP, on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving anti-GARP CAR T cell therapy may be safe, tolerable, and\u002For effective in treating patients with recurrent grade III or IV gliomas.",[81,82,83,84,26,27],"Recurrent Malignant Glioma","Recurrent WHO Grade 3 Glioma","Recurrent WHO Grade 4 Glioma","WHO Grade 2 Glioma","2026-05-04",{"date":87,"type":32},"2026-05-08",{"date":89,"type":32},"2025-05-21",{"date":91,"type":20},"2027-05-31",{"name":93,"class":39},"Ohio State University Comprehensive Cancer Center",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100600005","continuous-glucose-monitoring-for-the-management-of-hyperglycemia-in-patients-with-glioblastoma-100600005","NCT07091864","Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma","Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma","Inclusion Criteria:\n\n* Presumed newly diagnosed GBM based on imaging findings consistent with GBM on brain MRI (e.g., heterogeneously enhancing mass with central necrosis and surrounding edema), as determined by the treating neuro-oncology team\n* Age ≥ 18 years at the time of consent\n* Karnofsky performance status (KPS) ≥ 70 at baseline\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n* Platelet count ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL\u002Fmin\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* Total bilirubin ≤ 1.5 × ULN\n* Willingness and ability to comply with CGM device use and attend dietary counseling sessions as part of the study protocol\n\nExclusion Criteria:\n\n* Recurrent glioblastoma or prior therapy for glioblastoma beyond surgical resection or biopsy\n* History of eating disorders (e.g., anorexia nervosa, bulimia) or substance use disorder within the past 12 months\n* Any other uncontrolled or inadequately managed medical illness (e.g., unstable cardiovascular, hepatic, renal, or psychiatric condition) that, in the opinion of the investigator, would interfere with study participation or interpretation of results\n* Concurrent diagnosis of another active malignancy requiring treatment\n* Pregnancy or breastfeeding at the time of enrollment\n* Documented history of type 1 diabetes mellitus",{"count":102,"type":20},116,[104],"NA","This clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) levels and improve survival. Glioblastoma is the most common malignant primary brain tumor in adults, with an average survival time of approximately 15-18 months despite therapy. Studies have shown that having a higher-than-normal amount of glucose in the blood (hyperglycemia) during radiation therapy is associated with poorer survival outcomes in glioblastoma patients. Hyperglycemia in glioblastoma patients is often driven by steroids that are commonly used during treatment. CGM uses a device that places a sensor under the skin that monitors glucose levels at regular intervals, providing real-time, or near real-time, glucose information. This can help to identify when a patient has changes in their glucose levels so they may receive necessary interventions or medications sooner. CGM may be an effective way for glioblastoma patients to manage their glucose levels, which may improve survival.",[107,27],"Glioblastoma, IDH-Wildtype","2026-05-01",{"date":110,"type":32},"2026-05-07",{"date":112,"type":32},"2025-07-29",{"date":114,"type":20},"2027-11-30",{"name":38,"class":39},3,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":49,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100608845","phase-2-study-of-tovorafenib-in-high-grade-glioma-and-diffuse-intrinsic-pontine-glioma-dipg-100608845","NCT07206849","Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)","A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway","Inclusion Criteria:\n\n* Patient must have previously enrolled on TarGeT-SCR.\n\n  1. Age Patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR.\n  2. Body Surface Area (BSA) Patients must have a BSA \\>0.3m2.\n  3. Diagnosis:\n\n     * Patients with a newly-diagnosed HGG, including DIPG, which harbor alterations in the MAPK pathway are eligible. All patients must have tumor tissue from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.\n     * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2\u002F3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4 glioma.\n     * All other HGGs must be WHO Grade 3 or 4.\n  4. Disease Status\n\n     • Patients must be newly diagnosed and enroll and start treatment within 35 days of completion of radiotherapy.\n\n     • Measurable disease is not required. Patients without measurable disease are eligible.\n     * Patients with primary spinal tumors are eligible.\n     * Patients with secondary or radiation-induced HGG are eligible.\n  5. TarGeT-B Strata Definitions\n\n     Patients must be able to be assigned to one of the strata below:\n\n     • Stratum A: Patients with intracranial, localized, non-pontine, and non-thalamic HGG harboring a BRAFV600 mutation (who do not meet criteria for Strata B or C).\n     * Stratum B: Patients with DIPG\u002FDMG as defined in Section 4.1.3 OR patients with localized, non-pontine, non-thalamic HGG harboring a MAPK alteration not included in Stratum A (KIAA1549:BRAF fusion, KRAS\u002FNRAS, CRAF\u002FRAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.\n     * Stratum C: Patients with metastatic HGG (including metastatic DIPG\u002FDMG) harboring a MAPK alteration (BRAFV600, KIAA1549:BRAF fusion, KRAS\u002FNRAS, CRAF\u002FRAF1, other RAF mutation, or FGFR alteration).\n  6. Presence of at least one relevant actionable somatic alteration:\n\n     • MAPK pathway alteration(s): BRAFV600 mutation (Strata A or C)\n     * KIAA1549:BRAF fusion (Strata B or C)\n     * KRAS\u002FNRAS alteration (Strata B or C)\n     * CRAF\u002FRAF1 alteration (Strata B or C)\n     * other RAF mutations (Strata B or C)\n     * FGFR alteration (Strata B or C)\n  7. Performance Level:\n\n     Karnofsky ≥ 50 for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n  8. Prior Therapy for HGG:\n\n     o Surgery, radiation (RT), and\u002For dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible but discouraged for patients with DIPG\u002FDMG. No other prior anticancer therapy for HGG will be allowed.\n\n     o Radiation therapy requirements: Patients must have received photon or proton focal radiotherapy if enrolling on Stratum A or B. Patients must have received craniospinal irradiation if enrolling on Stratum C.\n\n     o Radiotherapy, delivered photon or proton beam, must have been administered at a standard dose, including:\n\n     o 54 Gy in 30 fractions for DIPG\n\n     o 54-59.4 Gy in 30-33 fractions for other HGG\n\n     o 45-54 Gy for primary spinal cord HGG\n\n     o And\u002For 36-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54-60 Gy for intracranial metastasis.\n\n     o Any variances in the radiotherapy dose within 10% of standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.\n\n     o Timing between diagnosis and start of RT: Patients must have started RT within 31 calendar days of initial diagnosis which is defined as the date of diagnostic biopsy or resection. If a patient underwent two upfront surgeries e.g., biopsy then resection or debulking, this is the date of the second surgery.\n     * Timing post-RT: Patients must enroll and start treatment on TarGeT-B no later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT.\n  9. Organ Function Requirements\n* Adequate Bone Marrow Function Defined as:\n\n  • Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm3.\n\n  • Platelet count \\>= 100,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n\n  • Hemoglobin \\>8 g\u002FdL (may be transfused).\n* Adequate Renal Function Defined as:\n\nCreatinine clearance or radioisotope GFR \\> 70ml\u002Fmin\u002F1.73 m2 OR serum creatinine based on age\u002Fgender as follows:\n\nMaximum Serum Creatinine (mg\u002FdL) Age Male Female 1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n\n* 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n\n  * Adequate Liver Function Defined as:\n\n    * Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN).\n    * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 3 times the ULN.\n    * Serum albumin ≥ 2g\u002FdL.\n  * Adequate Cardiac Function Defined as:\n\n    • Left Ventricular Ejection fraction of ≥ 50% as measured by echocardiogram or multiple-gated acquisition (MUGA).\n    * QTc ≤ 450 msec (by Bazett formula).\n  * Adequate Neurologic Function Defined as:\n\n    * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled (see Appendix II).\n  * Normal Thyroid Function Defined as:\n\n    • Free throxine (T4) within institutional guidelines for normal range. It is acceptable for patient to be on thyroid supplementation as long as free T4 is within institutional guidelines for normal range prior to starting treatment.\n\n    10\\) Informed Consent All patients and\u002For their parents or legally authorized representatives must sign a written Informed Consent and Assent, when appropriate, will be obtained according to institutional guidelines.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding.\n2. Other Exclusion Criteria\n\n   • Patients with neurofibromatosis type 1 (NF-1) are not eligible for this study.\n\n   • Infection: Patients who have an uncontrolled infection are not eligible.\n\n   • Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.\n\n   • Patients with uncontrolled GI disease or other condition that could affect absorption or predispose participant to gastrointestinal ulceration are not eligible.\n3. Concomitant Medications • Corticosteroids: Patients receiving corticosteroids are eligible, but the use of corticosteroids must be reported.\n\n   • Investigational Agents\u002FDrugs: Patients who are currently receiving another investigational drug are not eligible. This includes targeted agents, monoclonal antibodies, herbal supplements, or other investigational agents other than tovorafenib.\n\n   • Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible with the exception of temozolomide given concurrently with radiotherapy.\n\n   • Anticonvulsants: Patients who are receiving enzyme-inducing anticonvulsants as listed in Appendix II, are not eligible.\n\n   • Patients who are receiving medications known to prolong QTc interval as listed in Appendix III are not eligible.\n\n   • As tovorafenib is a substrate of CYP2C8, patients should not take strong inhibitors or inducers of CYP2C8 (See Appendix VI), as they could alter the drug's pharmacokinetics. Medications that are substrates of CYP2C8 or CYP3A4 are allowed but should be used with caution.\n\n   • Medications that are substrates of breast cancer resistance protein (BCRP) with a narrow therapeutic index are prohibited during this study (Appendix IV).\n   * Patients who are receiving duloxetine, alosetron, or theophylline (CYP1A2 inhibitors) are not eligible.\n   * Patients on beta-blockers are not eligible.\n   * Selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), Fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft) should be used with caution but are not contraindicated.\n   * Anticoagulants: patients who are receiving therapeutic anticoagulants including warfarin, low-molecular weight heparin are not eligible.\n\n5\\) Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the participant, or could impair the assessment of study results are not eligible.","12 Months",{"count":126,"type":20},79,[23],"The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets.\n\nThe main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.",[130,131,56,55,26,27,132],"High Grade Glioma (HGG) of the Brain With BRAF Aberration","High Grade Glioma (III or IV)","Metastatic Brain Tumor",[134,135],"tovorafenib","high grade glioma","2026-04-03",{"date":138,"type":32},"2026-04-08",{"date":140,"type":20},"2026-05",{"date":142,"type":20},"2037-05",{"name":67,"class":39}]