[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-glioma-hgg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-glioma-hgg":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,83,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100399771","phase-1-trametinib-and-everolimus-for-treatment-of-pediatric-and-young-adult-patients-with-recurrent-gliomas-pnoc021-100399771",false,"NCT04485559","Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)","PNOC021: A Phase I Trial Evaluating the Combination of Trametinib and Everolimus in Pediatric and Young Adult Patients With Recurrent Low-Grade Gliomas and High-Grade Gliomas","Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high-grade glioma (HGG) (WHO grade III-VI)\n\n  * Participants with LGG who have had surgery alone are not eligible.\n  * Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected\n  * Participants with spinal cord primaries or disseminated disease are eligible\n* For enrollment, snap frozen tissue (150 mg) or 10 unstained 10 um formalin-fixed, paraffin-embedded (FFPE) slides for comprehensive genomic testing or results of prior testing is required\n\n  * If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs\n* Participants must have evaluable disease\n* Prior therapy: Participants must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, biologics, immunotherapy, or radiotherapy prior to entering this study\n\n  * Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if they had received nitrosourea. Biologic agents: Participant must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent \\>= 7 days prior to study registration. For biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration\n\n    * Participants may have received prior treatment with a mitogen-activated extracellular signal-regulated kinase (MEK) or Mechanistic target of rapamycin (mTOR) inhibitor but must not have developed severe (grade III or IV) clinically significant toxicity. (Participants who developed grade III or IV toxicity which was not presumed by the treating physician to be medically significant should be discussed with the study chair or co-chair)\n  * Monoclonal antibody treatment: Participants must have received their last dose at least four weeks prior to study registration\n  * Radiation: Participants must have: had their last fraction of local irradiation to the primary tumor, craniospinal irradiation (\\> 24 Gy) or total body irradiation \\> 12 weeks prior to registration; investigators are reminded to review potentially eligible cases to confirm disease progression and avoid confusion with pseudo-progression\n  * Bone marrow transplant: Participants must be: \\>= 6 months since allogeneic bone marrow transplant prior to registration; \\>= 3 months since autologous bone marrow\u002Fstem cell prior to registration\n  * Corticosteroids: Participants who are receiving steroids must be on a stable or decreasing dose for at least 1 week prior to registration\n* Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>= 50 for participants =\\\u003C 16 years of age. Participants 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* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (unsupported)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Hemoglobin \\>= 8 m\u002FdL (may be supported)\n* International normalized ratio (INR) =\\\u003C 1.5\n* Creatinine clearance or radioisotope growth factor receptor (rGFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine based on age\u002Fgender as follows:\n\n  * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n  * \\>= 16 years: 1.7 (male), 1.4 (female)\n* Bilirubin (sum of conjugated + unconjugated) =\\\u003C 1.5 x upper limit of normal (ULN) for age\n* Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Serum albumin \\>= 2 g\u002FdL\n* Sodium, potassium, calcium and magnesium within 1.5 x institutional lower limit of normal (LLN) or ULN\n* Participants must have cholesterol level \\\u003C 350 mg\u002FdL and triglycerides \\\u003C 400 mg\u002FdL before starting therapy. In case one or both of these are exceeded, the participant can only be included after initiation of appropriate lipid lowering medication and documentation of cholesterol \\\u003C 350 mg\u002FdL and triglycerides \\\u003C 400mg\u002Fdl before start of therapy\n* Participants with seizure disorder may be enrolled if well controlled. Participants must be on non-enzyme inducing anticonvulsants which are not excluded on study therapy\n* Participants with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration\n* Corrected QT (QTc) interval =\\\u003C 450 msecs\n* Left ventricular ejection fraction (LVEF) \\>= 50%\n* Pulse oximeter (Ox) \\> 93% on room air\n* Hypertension\n\n  * Participants 3-17 years of age must have a blood pressure that is =\\\u003C 95th percentile for age, height, and gender at the time of registration\n  * Participants who are \\>= 18 years of age must have a blood pressure that is \\\u003C 140\u002F90 mm of Hg at the time of registration\n* Participants must agree to use adequate contraception: The effects of trametinib and everolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and males of child fathering potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of trametinib and everolimus administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participants must also enroll in a separate observational study to examine the effects of cancer therapies on them, if it is open to accrual at their site of enrollment\n* A legal parent\u002Fguardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate per institutional guidelines\n\nExclusion Criteria:\n\n* Participants that have received prior therapy with a MEK inhibitor in combination with an mTOR inhibitor\n* Participants who are receiving any other investigational agent for treatment of their tumor\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or trametinib\n* Participants without available tissue from prior surgery. (If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs)\n* Participant is receiving any of the following medications within 7 days prior to enrollment (If participants require (re)initiation of these agents after enrollment and prior to start of therapy they will not be eligible to initiate study therapy):\n\n  * Known strong inducers or inhibitors of CYP3A4\u002F5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos, starfruit, and Seville oranges\n  * Substrates of CYP3A4\u002F5 with a narrow therapeutic index\n  * Herbal preparations\u002Fmedications (except for vitamins) including, but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng. Participants should stop using all herbal medications at least 7 days prior to enrollment\n  * As part of the enrollment\u002Finformed consent procedures, the participant and\u002For legal parent or guardian will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product\n* Women of childbearing potential who are pregnant or breast-feeding\n\n  * Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of enrollment AND within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Human immunodeficiency virus (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised\n* Participants with known hepatitis B or C are not eligible\n* Participants with any clinically significant unrelated systemic illness (serious infectious or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the opinion of the investigator would interfere with the study procedures or results\n* Participants with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above are excluded","ALL","1 Year","25 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high-grade gliomas compared to trametinib or everolimus alone.",[27,28,29],"Recurrent World Health Organization (WHO) Grade II Glioma","Low-grade Glioma","High-Grade Glioma (HGG)",[31,32,33,34],"Mitogen-activated protein kinase (MAPK)","phosphatidylinositol 3-kinase (PI3K)","MAPK","PI3K","RECRUITING","2026-08-14",{"date":38,"type":39},"2026-08-18","ACTUAL",{"date":41,"type":39},"2020-12-09",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"University of California, San Francisco","OTHER",17,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100650738","phase-1-phase-12-study-evaluating-the-safety-pkpd-and-clinical-activity-of-oral-jbi-778-in-patients-with-brain-metastases-leptomeningeal-disease-or-recurrent-high-grade-glioma-100650738","NCT07751744","Phase 1\u002F2 Study Evaluating the Safety, PK\u002FPD, and Clinical Activity of Oral JBI-778 in Patients With Brain Metastases, Leptomeningeal Disease, or Recurrent High Grade Glioma","A Phase 1\u002F2, Multicenter, Open-Label, Dose-Escalation\u002FExpansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered JBI-778 in Patients With Brain Metastasis, Leptomeningeal Disease, or High Grade Recurrent Glioma","Inclusion Criteria:\n\nMale or female patients aged ≥18 years.\n\nHistologically or cytologically confirmed:\n\nSolid tumors with stable brain metastases (Dose Escalation Part), or Recurrent\u002Fprogressive high-grade glioma, or Brain metastases from NSCLC, breast cancer, or melanoma, or Leptomeningeal disease (Dose Expansion Part).\n\nAdequate organ function:\n\nANC ≥1,500\u002Fmm³ Platelets ≥100,000\u002Fmm³ Hemoglobin \\>8.0 g\u002FdL Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert syndrome) AST\u002FALT ≤2.5 × ULN (≤5 × ULN if liver metastases present) Creatinine clearance ≥60 mL\u002Fmin PT\u002FaPTT ≤1.5 × ULN (or stable anticoagulation therapy) At least one measurable lesion on MRI according to applicable RANO criteria, or positive CSF cytology for leptomeningeal disease.\n\nResolution of clinically significant toxicities from prior therapy to Grade ≤1 (except alopecia, Grade 2 peripheral neuropathy, or chronic Grade 2 endocrinopathies due to prior immunotherapy).\n\nECOG performance status ≤2. Ability to swallow oral medication. Life expectancy ≥3 months. Willing and able to provide written informed consent. Willingness to use effective contraception during treatment and for 3 months after the last dose.\n\nAdditional Dose Escalation Cohort Inclusion Criteria:\n\nHistologically or cytologically confirmed solid tumors with stable treated brain metastases and no available effective treatment options.\n\nNeurologically stable brain metastases without progression or hemorrhage for ≥4 weeks following treatment.\n\nOff systemic corticosteroids for symptomatic brain metastases for ≥14 days before enrollment.\n\nAdditional Dose Expansion Cohort Inclusion Criteria:\n\nRecurrent or progressive high-grade glioma after standard therapy including radiation and temozolomide.\n\nBrain metastases from melanoma, NSCLC, or breast cancer meeting protocol-defined prior treatment requirements.\n\nLeptomeningeal disease with protocol-defined prior therapy requirements.\n\nExclusion Criteria:\n\nSystemic anticancer therapy or investigational therapy within 2 weeks or 5 half-lives before first dose.\n\nMajor surgery within 21 days before first dose or not recovered from surgery. Conditions that may significantly impair drug absorption. Radiotherapy within 2 weeks prior to study treatment (except permitted palliative radiation or stereotactic radiosurgery).\n\nSevere or unstable medical conditions including:\n\nNYHA Class III\u002FIV heart failure Uncontrolled hypertension Uncontrolled diabetes Significant psychiatric illness Uncontrolled arrhythmias Myocardial infarction within 6 months Congenital long QT syndrome or QTcF \\>470 msec. History of optic neuritis or optic neuropathy. Other active malignancy likely to interfere with study assessments. Live vaccine within 30 days before first dose. Known active HIV infection or active hepatitis B or C infection (HCV RNA-negative patients may be eligible).\n\nUse of strong or moderate CYP3A inhibitors within 14 days or 5 half-lives before Cycle 1 Day 1, or grapefruit-containing products within 7 days.\n\nActive gastrointestinal disease or malabsorption syndrome affecting drug absorption.\n\nAcute illness within 14 days before first dose unless approved by investigator and sponsor.\n\nActive infection requiring systemic antimicrobial or antiviral therapy not completed before treatment.\n\nPregnant or breastfeeding women. Concurrent participation in another investigational drug study. Previous treatment with JBI-778 in this study. Any condition that, in the investigator's opinion, places the patient at unacceptable risk or prevents compliance with study requirements.\n\nFor Dose Escalation Part only: ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of brain metastases (except protocol-permitted low-dose corticosteroids).","18 Years",{"count":57,"type":21},113,[24,59],"PHASE2","This is a Phase 1\u002F2, multicenter, open-label, dose-escalation and dose-expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), cerebrospinal fluid penetration, and preliminary antitumor activity of orally administered JBI-778, a selective PRMT5 inhibitor, in patients with brain metastases, leptomeningeal disease, or recurrent high-grade glioma. The study consists of a dose-escalation phase to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), followed by expansion cohorts to evaluate preliminary efficacy at the RP2D.",[62,63,64,65],"Brain Metastases From Solid Tumors","Leptomeningeal Disease","High Grade Glioma (HGG)","Glioblastoma (GBM)",[67,68,69,63,70,71],"JBI-778","PRMT5 Inhibitor","Brain Metastases","High-Grade Glioma","Glioblastoma","NOT_YET_RECRUITING","2026-08-03",{"date":75,"type":39},"2026-08-07",{"date":77,"type":21},"2028-04-01",{"date":79,"type":21},"2030-03-31",{"name":81,"class":82},"Jubilant Therapeutics Inc.","INDUSTRY",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100648706","feasibility-assessment-of-a-medical-device-for-tumour-cell-retention-and-radiotherapy-sensitization-in-patients-with-suspected-high-grade-glioma-100648706","NCT07725640","Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma","CT-GlioHook","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent prior to the performance of any study-specific procedures.\n2. Age ≥18 and \\\u003C70 years at the time of consent.\n3. Suspected newly diagnosed unifocal high-grade glioma, as suggested by preoperative MRI imaging.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Supratentorial and\u002For lobar tumor mass with a volume of less than 60cm3 as assessed by preoperative MRI.\n6. Patient scheduled to undergo surgical resection of the target brain lesion, with an expected extent of resection (EOR) ≥90% based on preoperative imaging and surgical planning and according to the investigator's criteria. The anticipated EOR should be verified intraoperatively using a validated available method depending on availability at study site, such as 5-aminolevulinic acid (5-ALA) fluorescence guidance, ultrasound, or MRI.\n7. Candidate to receive standard-of-care treatment for newly diagnosed glioblastoma, according to current clinical practice and the investigator's judgment.\n8. Able to undergo contrast-enhanced MRI.\n9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and study procedures and accessible for follow-up after completion of study treatment.\n10. For women of childbearing potential (WOCBP):\n\n    * Must have a negative serum or urine pregnancy test within 7 days prior to inclusion.\n    * Must not be pregnant or breastfeeding at the time of inclusion.\n    * Must agree to use a highly effective method of contraception during the entire study participation period and for at least 6 months after the last dose of temozolomide.\n11. Male and female patients of reproductive potential must agree to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C3 months, as estimated by the investigator.\n2. Surgical resection cannot be assured or is considered not feasible or unsafe based on preoperative assessment.\n3. Tumor located in the posterior fossa or involving critical subcortical structures (e.g., midbrain, brainstem, ventricles, or basal ganglia), where safe surgical resection cannot be achieved.\n4. Presence of multifocal, bilateral, or recurrent tumor, or prior diagnosis of glioblastoma or other intracranial malignancy.\n5. Extent of tumor resection \\\u003C90%. The EOR should be verified intraoperatively using a validated available method depending on availability at study site, such as 5-aminolevulinic acid (5-ALA) fluorescence guidance, ultrasound, or MRI. However, it is up to the neurosurgeon to assess, after reviewing the available data and the resection itself, whether the patient meets the criteria for implantation.\n6. Significant active or uncontrolled concurrent medical conditions, including but not limited to:\n\n   * Active infection requiring systemic therapy,\n   * Symptomatic congestive heart failure,\n   * Unstable angina pectoris,\n   * Clinically significant cardiac arrhythmia,\n   * Uncontrolled hypertension,\n   * Severe pulmonary, hepatic, or renal disease,\n   * Psychiatric or social conditions that, in the opinion of the investigator, would interfere with study compliance or follow-up.\n   * Severe blood clotting disorders\n7. Known hypersensitivity to bovine-derived collagen or other components of the medical device.\n8. Contraindication to contrast-enhanced MRI, including known allergy to gadolinium or presence of non-MRI-compatible implants.\n9. Contraindication to receive radiotherapy or temozolomide, including prior cranial irradiation exceeding safe cumulative dose limits.\n10. Participation in another interventional clinical trial or use of an investigational product within 30 days prior to inclusion, or planned participation during this clinical investigation.\n11. Women who are pregnant or breastfeeding.\n12. Men or women of reproductive potential unwilling to use adequate contraception, as defined in the inclusion criteria.\n13. Inability or unwillingness to comply with clinical investigation procedures, follow-up schedule, or CIP requirements, as judged by the investigator.","70 Years",{"count":92,"type":21},15,[94],"NA","This is a prospective, multicenter, single-arm, pilot clinical investigation, aimed at evaluating the safety and preliminary efficacy of the GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment.\n\nGlioHook is a sterile medical device designed to be implanted after tumour resection surgery in suspected high grade glioma patients, covering the entire surface of the tumour resection margins, decreasing infiltration and focalizing the disease, while improving the effects of radiotherapy. Once implanted, GlioHook exerts a dual mechanism that combines tumour cell focalization and radiosensitization.",[97,29,98],"Glioma","Surgical Resection",[100,70,101,102],"Implant","Radiotherapy","Temozolomide","2026-07-24",{"date":105,"type":39},"2026-07-27",{"date":107,"type":21},"2026-10-30",{"date":109,"type":21},"2028-10-30",{"name":111,"class":82},"Batea Oncology",3,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100636575","phase-1-a-safety-and-efficacy-study-of-combined-fianlimab--cemiplimab-in-children-and-young-adults-with-recurrent-or-progressive-high-grade-glioma-or-posterior-fossa-a-ependymoma-100636575","NCT07567469","A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma","A Phase 1\u002F2 Open-Label, Safety and Efficacy Study of Neoadjuvant Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) and Cemiplimab Alone Followed by Adjuvant Fianlimab in Combination With Cemiplimab in Pediatric and Young Adult Participants With Recurrent or Progressive High-Grade Glioma or Pediatric and Adult Participants With Recurrent or Progressive Posterior Fossa-A Ependymoma","Key Inclusion Criteria:\n\n1. Participant must be diagnosed with recurrent\u002Fprogressive HGG or PF-A ependymoma with unequivocal progression on Magnetic Resonance Imaging (MRI) as described in the protocol\n2. Participant must have histologically confirmed (at initial diagnosis or relapse) HGG or PF-A ependymoma\n3. Participant must be an adequate medical candidate for surgical resection as described in the protocol\n4. Karnofsky Performance Status (KPS) score ≥50 (in participants ≥16 years) or Lansky Performance Status (LPS) score ≥50 (in participants \\\u003C16 years) as described in the protocol\n5. Adequate organ function as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Active autoimmune disease requiring systemic immunosuppressive therapy in the past 2 years\n2. Active, serious medical illness, infection or other systemic illness which would limit participation in the trial\n3. Has not yet recovered from any acute toxicities resulting from prior therapy\n4. History of myocarditis\n5. Prior treatment with antibodies to Programmed Cell Death Protein -1 (PD-1), Programmed Cell Death Protein Ligand -1 (PD-L1), Lymphocyte Activation Gene 3 (LAG3), or Cytotoxic T-Lymphocyte Associated protein 4 (CTLA-4)\n6. Treatment with high dose systemic corticosteroids as described in the protocol\n7. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management\n\nNote: Other protocol defined Inclusion\u002F Exclusion Criteria apply","0 Years","39 Years",{"count":123,"type":21},120,[24,59],"This study is researching an experimental drug called cemiplimab (called \"study drug\") and the combination of experimental drugs of fianlimab and cemiplimab (called \"study drugs\"). The study is focused on children and young adults with recurrent or progressive High-Grade Glioma (HGG) or ependymoma. \"Recurrent\" means that the cancer came back after treatment. \"Progressive\" means that the tumor has grown or spread.\n\nThe aim of the study is to see how safe, tolerable, and effective cemiplimab and the combination of fianlimab and cemiplimab are.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from receiving the study drug(s)\n* Do the study drug(s) help study participants live longer without their tumors growing or spreading\n* How much of the study drug(s) is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug\\[s\\] less effective or lead to side effects)",[29,127],"Posterior Fossa-A Ependymoma",[129,130,131,132,133],"Recurrent","Progressive","Pediatric Central Nervous System (CNS) tumors","Posterior Fossa A (PF-A)","Ependymoma","2026-04-28",{"date":136,"type":39},"2026-05-05",{"date":138,"type":21},"2026-08-31",{"date":140,"type":21},"2034-08-17",{"name":142,"class":82},"Regeneron Pharmaceuticals"]