[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed-glioblastoma":219},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,60,94,124,156,182,204,235],{"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":33,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100618049","phase-2-study-of-silevertinib-with-temozolomide-for-the-treatment-of-newly-diagnosed-gbm-with-unmethylated-mgmt-and-egfrviii-100618049",false,"NCT07326566","Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","Key Inclusion Criteria:\n\n* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).\n* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).\n* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.\n* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.\n* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.\n* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.\n* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.\n\nKey Exclusion Criteria:\n\n* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.\n* Progression of GBM prior to Enrollment, Screening, or Randomization.\n* Biopsy-only\u002Fno resectional surgery.\n* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.\n* Intent to use Optune® (TTF).\n* Significant other uncontrolled health conditions or other malignancies.","ALL","18 Years",{"count":19,"type":20},162,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.\n\nSpecifically, this study is being done to find answers to the following questions:\n\n* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?\n* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?\n* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?",[26,27,28,29,30,31,32],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","GBM","Glioblastoma Multiforme (GBM)","Glioma","Central Nervous System Diseases","Brain Cancer",[34,35,36,37,38,39,40,41,42,43,44,45,46],"EGFR","Glioblastoma","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","temozolomide","Temodar","silevertinib","BDTX-1535","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)","RECRUITING","2026-06-18",{"date":50,"type":51},"2026-06-22","ACTUAL",{"date":53,"type":51},"2026-05-05",{"date":55,"type":20},"2029-03",{"name":57,"class":58},"Black Diamond Therapeutics, Inc.","INDUSTRY",14,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100619555","phase-1-study-of-an-aav-mediated-dual-payload-gene-therapy-in-patients-with-high-grade-glioma-100619555","NCT07346144","Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","A Phase I\u002FII Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","ADePT","Inclusion Criteria:\n\n* Aged 18-70 years\n* Karnofsky performance status ≥70\n* Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI\n* Recurrent patients: First radiological progression (as determined by the multidisciplinary team \\[MDT\\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological\u002Fmolecular diagnosis of GBM\n* Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)\n* Debulking surgery is indicated for optimal patient care\n* Able to swallow oral medication\n* Willing to avoid live vaccines\n* Adequate organ function\n* Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0.\n* All patients must agree to practice true abstinence or to use highly effective contraception\n* Patient is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patient who is pregnant, lactating or planning pregnancy during the course of the study\n* Immunodeficiency or active auto-immune disease requiring systemic therapy.\n* Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery\n* Live vaccine within 28 days prior to Day 0\n* Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0\n* History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection\n* Received previous treatment with a gene therapy\n* Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment\n* Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted\n* Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007\n* Contraindication to MRI with gadolinium\n* Any condition expected to interfere with the intended timing of debulking surgery\n* Previous non-glioma cancer within 3 years (other than treated squamous\u002Fbasal cell skin cancer, treated early-stage cervical cancer or treated\u002Fbiochemically stable, organ confined prostate cancer)\n* Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study\n* Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product\n* Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the study\n* Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study\n\nNewly diagnosed patients only:\n\n* Any prior therapy for glioma\n* Intended use of tumour treating fields\n\nRecurrent patients only:\n\n* Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity\n* Intended use of tumour treating fields","70 Years",{"count":70,"type":20},68,[72,23],"PHASE1","The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma.\n\nTGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour.\n\nPatients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery.\n\nThe study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM.\n\nApproximately 68 people aged 18-70 will take part in the study.",[26,75,76,27],"High Grade Gliomas","Recurrent Glioblastoma",[35,78,79,80,81,82,83],"Immunotherapy","Gene Therapy","AAV","HSV-tk","IL-12","TGX-007","2026-06-11",{"date":86,"type":51},"2026-06-12",{"date":88,"type":51},"2026-04-21",{"date":90,"type":20},"2033-09",{"name":92,"class":58},"Trogenix ltd",2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100563920","phase-1-new-adjuvant-vaccine-in-glioblastoma-a-phase-12a-study-100563920","NCT06622434","New Adjuvant Vaccine in Glioblastoma, a Phase 1\u002F2a Study","New Adjuvant Vaccine in Glioblastoma, a Phase 1\u002F2a Study (NAVIG-1)","NAVIG-1","Inclusion Criteria:\n\n* age between 18 and 75 years old\n* free, informed and written consent signed\n* Histologically confirmed glioblastoma\n* Patients previously treated with concurrent radiotherapy (at least 45 Gy) with concomitant temozolomide, before the beginning of the 6 additional monthly cycles of temozolomide. Radiation therapy must have been completed 28 to 45 days prior to the first study treatment\n* Karnofsky Performance Status ≥ 60%\n* Phase 1 only: Patients must be human leukocyte antigen (HLA)-A2 positive.\n* Phase 1 only: PTPRZ1 expression in the tumor\n* Available tumor tissue for post hoc (retrospective) assessment of TERT promoter mutations and MGMT promoter methylation status\n* Life expectancy ≥ 3 months\n* Adequate organ function laboratory values within 15 days before initiation of treatment (see table in section 6.1)\n* Women or Male of childbearing potential (WOCBP) must use contraceptive methods during and for 180 days after the last dose of temozolomide or up to 120 days after the last dose of vaccine, whichever is longer (see section 6.3). No sperm donation during the study and until 7 months after the end of the treatment period.\n* Patient affiliated to the social security scheme\n\nExclusion Criteria:\n\n* Known extracranial metastatic or leptomeningeal disease\n* Grade 4 astrocytoma IDH mutant\n* Steroid requirement \\>10 mg prednisone daily (or equivalent) at time of inclusion\n* Patients with prior malignancy active within the last 3 years\n* Patients receiving immunomodulatory or immunosuppressive therapy\n* Carmustine wafers (GliadelR) implantation during surgery\n* Phase 1 only: patient eligible and willing to be treated with Optune (TTF fields)\n* History of autoimmune disease (lupus, rheumatoid arthritis, inflammatory bowel disease...)\n* Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists\n* Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study.\n* Uncontrolled active systemic fungal, bacterial, viral, or other infection within the previous 4 weeks or requirement for intravenous (IV) antibiotics within the last two weeks\n* Breast-feeding or pregnant women.\n* Contra-indications to IRM\n* Contra-indications to investigational medicinal product and\u002For to auxiliary medicinal products\n* Participation to another interventional clinical trial, clinical investigation or another interventional study or being in the exclusion period at the end of a previous study\n* Patient unable to follow the procedures and constraints of the protocol\n* Patient under legal protection (protection of the court, or in curatorship or guardianship).","75 Years",{"count":104,"type":20},35,[72,23],"This phase I\u002FII trial evaluates the safety and the immunological efficacy of a cancer vaccine against 2 glioma-associated antigens in newly-diagnosed glioblastomas.\n\nThe objectives of this study are as follows:\n\nPrimary objective\n\n* phase 1:\n* to assess the maximum tolerated dose (MTD) and select the recommend Phase 2a dose\n* phase 2a:\n* to assess anti- TERT specific T cell responses at 2 months at the selected dose level\n\nSecondary objectives:\n\n* To assess Short and long-time immunological safety\n* To assess Evolution of anti-PTPRZ1 and anti-TERT immune T cell responses over time\n* To assess Progression free survival (RANO 2.0 criteria)\n* To assess Overall survival\n* To assess Quality of life by EORTC QLQ30 and BN20 questionnaires\n* To evaluate cardiac safety and monitor for the potential development of anti-melanin antibodies in a cohort of 8 patients enrolled in the Phase 2a study\n\nas well as objective of ancillary study: to determine the mechanism of action of potential tumour escape in GBM (T-cell lymphocyte phenotype; antigen expression and checkpoint inhibitors on tumour cells at relapse, if available), analysis of circulating antibodies against TERT epitope and\u002For melanin, and identification of predictive biomarkers of response.\n\nUltimately, this trial together will lead to the implementation of future phase III trial in GBM.\n\nAll patients enrolled in the study will receive standard treatment consisting of surgical resection of the tumor followed by radio-chemotherapy. Immunotherapy will begin 4 weeks after the completion of radiotherapy.",[27],[109,35,110,111,112,113],"Cancer vaccine","Telomerase","TERT","PTPRZ1","Immunomodulation","2026-06-09",{"date":84,"type":51},{"date":117,"type":51},"2024-11-08",{"date":119,"type":20},"2028-03-08",{"name":121,"class":122},"Assistance Publique - Hôpitaux de Paris","OTHER",3,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100505680","phase-2-phase-2a-immune-modulation-with-ultrasound-for-newly-diagnosed-glioblastoma-100505680","NCT05864534","Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma","A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Have newly diagnosed pathologically proven glioblastoma, isocitric dehydrogenase-1\u002F2 wild-type\n* Tumor with methyl guanine methyl transferase (MGMT) gene promoter unmethylated\n* Available paraffin embedded tumor tissue for the study\n* Have completed standard radiotherapy with or without temozolomide\n* 18 years of age or older\n* Able to undergo contrast-enhanced MRI\n* Have an Eastern Cooperative Oncology Group\u002FWorld Health Organization performance status ≤ 2\n* Size and location of the residual tumor and\u002For resection cavity must allow to be able to be covered by the sonication field\n* Have not received any prior treatment with immunotherapeutic agents treatments for glioblastoma or other indications\n* Have the ability to understand and willingness to sign a written informed consent prior to registration on study.\n* Be willing and able to comply with the protocol.\n* Have adequate organ and bone marrow function\n* Agree to use adequate contraception if appropriate\n\nExclusion Criteria: Patients will be ineligible if they have:\n\n* Multifocal tumor (unless all localized in a 50-mm diameter area accessible to ultrasound field) or tumor located in the posterior fossa.\n* Uncontrolled epilepsy.\n* Received other investigational agents within 2 weeks of registration\n* Received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.\n* Contraindication to checkpoint inhibitor therapy (e.g., history of autoimmune disease)\n* Uncontrolled illness\n* History of active malignancy other than the brain tumor within 12 months prior to registration.\n* Are pregnant or breastfeeding.",{"count":132,"type":20},25,[23],"Brain tumor treatment is hampered by the blood-brain barrier (BBB). This barrier prevents drugs carried in the bloodstream from getting into the brain. If the BBB can be opened, making it temporarily more permeable, drugs may able to better reach the brain tumor. In this trial we will implant a novel device with 9 ultrasound emitters, allowing temporary and reversible opening of the BBB to maximize brain penetration of drugs that modulate the immune system. The device will be implanted after radiation is completed. Immune modulating drugs will be given every 3 weeks in conjunction with activation of the device to open the BBB.\n\nThe objectives of this trial are to establish whether it is safe and feasible to administer immune modulating drugs in this manner, and identify whether the treatment is effective in treating glioblastoma.",[27,136,137,138],"Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype","Gliosarcoma","Glioblastoma Multiforme",[78,140,141,142,143,144,145],"Ultrasound","Blood-brain barrier","Sonocloud","Balstilimab (BAL)","Botensilimab (BOT)","Doxorubicin (DOX)","2026-05-08",{"date":148,"type":51},"2026-05-13",{"date":150,"type":51},"2024-01-19",{"date":152,"type":20},"2031-08-31",{"name":154,"class":122},"Northwestern University",1,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":155},"100431875","phase-1-brite---bispecific-t-cell-engager-for-patients-with-glioblastoma-100431875","NCT04903795","BRiTE - Bispecific T Cell Engager for Patients With Glioblastoma","A Phase 1 Study of Bispecific T Cell Engager (BRiTE) in Patients With Newly Diagnosed or Recurrent Glioblastoma","BRiTE","Inclusion Criteria:\n\n1. Age ≥ 18 years old at the time of entry into the study\n2. For both newly diagnosed and recurrent patients, pathologically documented supratentorial WHO grade 4 GBM with a confirmed EGFRvIII mutation at the most recent diagnosis, with radiographic contrast enhancing disease that is ≤ 4 cm in maximal diameter in any plane before resection.\n\n   i. ndGBM patients: Must have undergone surgical resection of their tumor. Patients are still eligible if they have measurable or non-measurable residual enhancing tumor following resection, providing they meet all other eligibility criteria. Newly diagnosed patients must complete standard of care RT with or without TMZ before participation, depending on the MGMT promoter methylation status as follows:\n   1. Patients with methylated MGMT promoter status should have received standard of care concomitant RT and TMZ, followed by 6 cycles of adjuvant TMZ, before they can participate in this study\n   2. Patients with an unmethylated MGMT promoter status should have received standard of care RT, but need not have received concomitant TMZ or 6 cycles of adjuvant TMZ and can be enrolled after 4 weeks from completion of standard of care RT\n   3. Patients whose MGMT status is unknown or indeterminate will be treated as though they have a methylated MGMT promotor status for eligibility purposes\n   4. RT for 3 or 6-week courses are accepted as follows:\n\n      * Typically, 59.4-60 Gy over approximately 6 weeks duration, if under 65 years old\n      * A minimum of 40 Gy over 3 weeks duration, if 65 years or older\n   5. Patients who progress during RT or within 4 weeks after completion of RT are not eligible.\n\n   ii. rGBM patients at first progression: Must have pathological or radiographic confirmation of their tumor recurrence that is ≤ 4 cm in maximal diameter in any plane.\n\n   Note: Patients that undergo total gross resection at time of recurrence are eligible to enroll. Patients are still eligible if they have measurable or non-measurable residual enhancing tumor following resection, providing they meet all other eligibility criteria.\n3. Karnofsky Performance Score (KPS) ≥ 70%\n4. Able to undergo brain MRI with and without contrast. Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies (i.e. pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates) or patients with any known severe allergies to contrast agents are not eligible. Patients with mild allergies (i.e., rash only) are eligible for inclusion and can be pretreated with acetaminophen and diphenhydramine prior to injection of the contrast agent.\n5. Hematological function as follows:\n\n   i. Hemoglobin ≥ 9.0 g\u002FdL ii. Absolute neutrophil count (ANC) ≥ 750\u002Fmm3 iii. Platelet count ≥ 50,000\n6. Renal function as follows:\n\n   i. Creatinine ≤ 1.5 x ULN\n7. Hepatic function as follows:\n\n   i. Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) ii. Alanine aminotransferase (ALT) ≤ 2.5 x ULN iii. Total bilirubin ≤ 1.5 x ULN Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.\n8. Patient or partner(s) meets one of the following criteria:\n\n   1. Non-childbearing potential (i.e. not sexually active, physiologically incapable of becoming pregnant, including any person who is post-menopausal or surgically sterile, or any person who has had a vasectomy). Surgically sterile people are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study is defined as 1 year without menses; or\n   2. Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide while on study and for an additional 4 months after completing the last infusion of BRiTE.\n9. Patients of childbearing potential must have negative serum pregnancy test within 1 week of the 1st BRiTE infusion\n10. A signed ICF approved by the IRB will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study. Patient must also agree that a caregiver will accompany them for the Day 4 (96 hours) clinic visit during every cycle of BRiTE and be present with them for 24 hours after the end of the infusion.\n\nExclusion Criteria for All Patients:\n\n1. Patients who are pregnant or breastfeeding\u002Fchestfeeding\n2. Patients with baseline corrected QT interval (QTc) \\> 480ms on screening electrocardiogram (ECG).\n\n   Note: QTc measurements will use Fridericia's correction method (QTcF).\n3. Known hypersensitivity to immunoglobulins or to any other component of BRiTE\n4. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate\n5. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin\n6. Patients with severe, active co-morbidity, defined as follows:\n\n   i. Patients with an active infection requiring IV treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C) ii. Patients with known immunosuppressive disease or known HIV infection, with CD4+ T cell counts \\\u003C 350 cells\u002Fµl iii. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4) iv. Patients with known lung (forced expiratory volume in the first second of expiration \\[FEV1\\] \\\u003C 50%) disease or uncontrolled diabetes mellitus v. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy\n7. Patients with known Human Immunodeficiency Virus (HIV) positive status only if CD4+ T cell counts \\\u003C 350 cells\u002Fµl. Patients with known HIV and CD4+ T cell counts over 350 cells\u002Fµl are eligible.\n8. Patients with known hepatitis C virus (HCV) positive status, who have not completed curative antiviral treatment and have HCV viral load above the limit of quantification. Patients with well-controlled HCV are eligible.\n9. Patients with known hepatitis B virus (HBV) infection, with evidence of a hepatitis B surface antigen, indicative of an active infection. Patients with well-controlled HBV are eligible.\n10. Patients on corticosteroids ≥ 2 mg dexamethasone daily or equivalent within 7 days of 1st BRiTE infusion\n11. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n12. Toxicities from prior antitumor therapy that have not resolved to CTCAE version 5.0 grade 1 (with the exception of AEs reflecting myelosuppression such as neutropenia, anemia, or thrombocytopenia), or to levels dictated in the eligibility criteria. Other exceptions include alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for \\> 2 months) are allowed if they are not otherwise described in the exclusion criteria.\n\nExclusion Criteria for ndGBM Patients Only:\n\n1. Patients who previously received other therapeutic interventions for ndGBM, with the exception of surgical resection and standard of care concomitant RT and TMZ (including adjuvant TMZ) for their brain tumor\n2. Patients who have had only a biopsy prior to receiving standard of care concomitant RT and TMZ\n3. Unmethylated MGMT patients who have received RT \\\u003C 4 weeks prior to initiation of BRiTE infusion\n\nExclusion Criteria for rGBM Patients Only:\n\n1. Patients who have received chemotherapy or bevacizumab ≤ 4 weeks \\[except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\\] prior to enrollment unless patients have recovered from side effects of such therapy\n2. Patients who have received immunotherapy prior to enrollment\n3. Patients less than 12 weeks from RT, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation prior to enrollment",{"count":165,"type":20},18,[72],"This Phase 1 study will assess the safety of a novel brain Bispecific T cell engager (BRiTE) in patients with newly diagnosed or recurrent World Health Organization (WHO) Grade 4 glioblastoma (GBM). Owing to its short half-life, the study drug, BRiTE, will be continuously infused intravenously (IV) for 4 days (96 hours) in a 28-day cycle. Given that BRiTE specifically exerts its effects on tumor cells expressing the Epidermal Growth Factor Receptor variant III (EGFRvIII) mutation, we will only enroll patients with EGFRvIII-positive tumors in this study.\n\nThe primary objective is to evaluate the safety and tolerability of continually infused BRiTE in ndGBM and rGBM patients and determine the maximum tolerated dose (MTD) for continuously infused BRiTE.",[27,76],[45,170,162,171],"Khasraw","Pro00108079","NOT_YET_RECRUITING","2026-04-22",{"date":175,"type":51},"2026-04-27",{"date":177,"type":20},"2026-04",{"date":179,"type":20},"2027-12",{"name":181,"class":122},"Mustafa Khasraw, MBChB, MD, FRCP, FRACP",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":155},"100578871","phase-2-trial-of-glioblastoma-immunotherapy-advancement-with-nivolumab-and-relatlimab-100578871","NCT06816927","Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab","A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab (GIANT)","GIANT","Inclusion Criteria:\n\n1. Signed informed consent approved by the IRB\n2. Adults ≥ 18 years of age\n3. Patients with either:\n\n   * A newly suspected diagnosis of GBM based on MRI\n   * A previous diagnosis of GBM and who have not received prior RT or systemic therapy for their brain tumor\n4. Patients who in the opinion of the treating neurosurgeon require resection\n5. Patient is willing to undergo planned surgical procedures\n6. Patient agrees to make biospecimens that will be prospectively collected (after date of consent) available for research\n7. Patients who have undergone a diagnostic biopsy or open surgical procedure prior to enrolling in this study:\n\n   * If adequate archival tissue, defined as at least 3 blocks, is readily available, there is clear documentation of its availability, and the patient must consents to provide that tissue, the patient does not need to undergo another biopsy prior to, or on study, in order to be eligible for this trial\n   * If archival tissue is sufficient as described above, patient must have either residual enhancing disease requiring resection, or molecularly confirmed GBM with a clear clinical indication for additional resection, as determined by the country PI (or delegate) and the designated trial surgeon.\n   * If archival tissue is insufficient, or if the patient previously underwent a needle biopsy and there is no clear documentation of tissue availability, and the patient wishes to enroll, the patient must agree to undergo a repeat biopsy as part of this study prior to Screening.\n8. Hematological function as follows:\n\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Haemoglobin \\> 90 g\u002FL\n   * Prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.5 x upper limit of normal (ULN)\n9. Renal function as follows:\n\n   • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 ml\u002Fmin using the Cockcroft-Gault formula (Appendix 1)\n10. Hepatic function as follows:\n\n    * Total bilirubin ≤ 1.5 x ULN (Exception: Patient has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable)\n    * Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n    * Serum albumin ≥ 25 g\u002FL\n11. Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 (Appendix 2)\n12. Life expectancy of at least 12 months\n13. Negative human immunodeficiency virus (HIV) test at Screening\n14. Negative hepatitis B surface antigen (HbsAg) test at Screening or positive test followed by a negative hepatitis B virus (HBV) DNA test at Screening\n15. Negative hepatitis C antibody (anti-HCV) test at Screening or positive test followed by a negative HCV RNA test at Screening\n16. Able to undergo brain MRI with and without contrast\n17. People of childbearing potential must agree to use a highly effective contraceptive method (with a failure rate of \\\u003C 1%) during study treatment and for at least 6 months following the last dose of study drug and agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Acceptable methods of contraception are:\n\n    * Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n    * Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n    * Intrauterine device: Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomised partner\n    * Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence needs will be evaluated in relation to the duration of the study and to the usual lifestyle of the patient Note: People are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the person has been confirmed by follow-up hormone level assessment are they considered not of childbearing potential.\n18. Sexually active patients that are able to produce a sperm, must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 3 months after the last dose of treatment\n19. People of childbearing potential must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) at the time of screening and within 48 hours of starting the study drug(s)\n20. Ability to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria:\n\n1. Tumors where a gross total resection is not considered feasible by the treating neurosurgeon\n2. Tumor involves cerebellum, brainstem, or deep basal ganglia\n3. Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon\n4. Patients with contraindications to MRI or unwilling to undergo MRI\n5. History of CNS bleeding as defined by stroke within 6 months prior to registration\n6. Contraindication to surgery\n7. Treatment with immunosuppressive medications Note: Low-dose corticosteroids (≤ 2 mg\u002Fday dexamethasone or equivalent) for tumor-associated edema is permitted. Patients who require corticosteroids \\> 2mg\u002Fday dexamethasone (or equivalent) for acute emergencies during the screening window will be eligible, if the corticosteroid dosing reduces to ≤ 2 mg\u002Fday dexamethasone (or equivalent) at least one day prior to the initial trial-mandated biopsy.\n8. Active autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis\n9. Active tuberculosis\n10. Patient has had a previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms must have resolved and based on treating physician's assessment, there are no sequelae that would place the patient at a higher risk of receiving trial treatment\n11. Evidence of acute intracranial\u002Fintra-tumoral hemorrhage, which requires urgent intervention\n12. Severe infection within 4 weeks prior to registration\n13. Treatment with a live, attenuated vaccine within 4 weeks prior to registration, or anticipation of need for such a vaccine during study or within 5 months after final dose of nivolumab and relatlimab\n14. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more\n15. Major surgical procedure, other than for diagnosis, within 4 weeks prior to registration\n16. History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n17. Patient is pregnant or breastfeeding\u002Fchestfeeding\n18. Prior allogeneic stem cell or solid organ transplantation\n19. Known allergy or sensitivity nivolumab, relatlimab, temozolomide or their excipients\n20. Patient has any kind of disorder that, in the opinion of the site PI, may compromise the ability of the patient to give written informed consent and\u002For to comply with all required study procedures\n21. Patients with a history of myocarditis\n22. Patient has troponin T (TnT) or I (TnI) \\> 2 × ULN Note: Patients with TnT or TnI levels between \\> 1 × to 2 × ULN will be eligible if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \\> 1 × to 2 × ULN within 24 hours, the patient must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the patient must be evaluated by a cardiologist. After cardiologist evaluation, the patient may be eligible if the site PI assesses a favorable benefit\u002Frisk\n23. Left ventricular ejection fraction (LVEF) \\\u003C 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 6 months prior to registration\n24. History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the site PI would pose a risk to patient safety or interfere with the study evaluation, procedures or completion",{"count":191,"type":20},92,[23],"GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).",[27],"2026-01-07",{"date":197,"type":51},"2026-01-09",{"date":199,"type":51},"2025-11-28",{"date":201,"type":20},"2031-06-01",{"name":203,"class":122},"Duke University",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":155},"100594583","phase-3-anterior-temporal-lobectomy-in-temporal-glioblastoma-100594583","NCT07021339","Anterior Temporal Lobectomy in Temporal Glioblastoma","Randomized, Controlled Trial of Anterior Temporal Lobectomy Versus Gross Total Resection in Newly-diagnosed Temporal Glioblastoma (ATLAS\u002FNOA-29)","ATLAS\u002FNOA-29","* Suspected glioblastoma with contrast-enhancement in preoperative MRI\n* Diffuse high-grade glioma in frozen section procedure, newly-diagnosed\n* Tumor localization (in gadolinium-enhanced MRI): solely temporal, non-dominant side (right hemisphere in right-handed patients, or left-handed patients after testing for dominance): within 6.5 cm from the temporal pole; dominant side (left hemisphere in right-handed patients, all left-handed patients unless additional testing for dominance performed): within 4.0 cm from the temporal pole, as determined dorsally along the Sylvian fissure.\n* Macroscopic complete resection (no remaining contrast-enhancing tumoral lesion on early postoperative MRI) is achievable (decision of the treating neurosurgeon)\n* In case further T1-contrast-enhancing and\u002For T2\u002FFLAIR lesions are detected beyond the resection margins (6.5 cm on the non-dominant side and 4.0 cm on the dominant side), these lesions are not attributed to the tumor (except perifocal edema) but to other conditions according to the local treating neurosurgeon\n* ≥ 18 and \\\u003C 75 years of age\n* KPS ≥ 70%\n* Estimated life expectancy of at least 6 months\n* Written informed consent\n* Cognitive state to understand the rationale and necessity of the study therapy and procedures\n* Patient compliance and geographic proximity that allow adequate follow-up\n* For patients with childbearing potential: negative serum pregnancy test (beta-HCG) at baseline visit, patient's commitment to use an approved contraceptive method during the trial and for 3 months after (Pearl index \\\u003C 1%)\n* Adequate organ function at baseline visit that does not preclude alkylating chemotherapy and neurosurgical procedures (all criteria required):\n\n  * Adequate bone marrow reserve: white blood cell (WBC) count ≥ 3.000\u002Fµl; granulocyte count \\> 1.500\u002Fµl; platelets ≥ 100.000\u002Fµl; haemoglobin ≥ 10 g\u002Fdl\n  * Adequate liver function: bilirubin \\\u003C 1.5 times above upper limit of normal range (ULN); alanine transaminase (ALT\u002FSGPT) and aspartate transaminase (AST\u002FALAT) \\\u003C 3 times ULN\n  * Adequate renal function: creatinine \\\u003C 1.5 times ULN\n* Adequate blood clotting: Partial Thromboplastin Time (PTT) not exceeding the upper limit of normal range and International Normalized Ratio (INR) \\\u003C1.5; in case of intake of anticoagulant medication or platelet function inhibitors, the coagulation analysis must show no detectable effect in specific blood tests (as described below) at the time of surgery, and discontinuation of the anticoagulant medication must be justifiable for at least 1 week postoperatively\n\n  * Direct acting oral anticoagulants (e.g., rivaroxaban, apixaban, edoxaban, dabigatran): anti-Factor Xa (aFXa)-activity within the normal range (rivaroxaban, apixaban, edoxaban), TT\u002FTCT (thrombin clotting time) or ecarin clotting time (ECT) not exceeding the upper limit of normal range (Dabigatran) or verification of subtherapeutic drug levels (apixaban, edoxaban, rivaroxaban, dabigatran)\n  * Vitamin K antagonists (coumarins): INR \\\u003C 1.5\n  * Unfractionated heparin (UFH) and argatroban: activated Partial Thromboplastin Time (aPTT) not exceeding the upper limit of normal range\n  * Fractionated heparin\u002Flow-molecular-weight heparin (e.g., dalteparin, enoxaparin), heparinoid (e.g., fondaparinux, danaparoid): aFXa-activity within the normal range\n  * Antiplatelet agents (aspirin, clopidogrel, prasugrel, ticagrelor): platelet function analyzer (PFA) test not exceeding the upper limit of normal range (aspirin), whole blood aggregometry not below lower limits of normal range (clopidogrel, prasugrel, ticagrelor)\n\nFor details see study protocol.","74 Years",{"count":214,"type":20},178,[216],"PHASE3","The ATLAS\u002FNOA-29 trial is a prospective, multicenter, phase III randomized controlled study evaluating whether anterior temporal lobectomy (ATL), a standardized resection technique adapted from epilepsy surgery, improves clinical outcomes in patients with newly diagnosed glioblastoma of the anterior temporal lobe compared to conventional gross-total resection (GTR). The rationale is based on the concept of glioblastoma as a diffusely connected tumor network, with infiltrative spread extending beyond MRI-detectable tumor margins. ATL offers a reproducible supramarginal resection approach within anatomical boundaries that are routinely respected in epilepsy surgery.\n\nPatients are randomized intraoperatively in a 1:1 ratio following histopathological confirmation via intraoperative frozen section procedure. The trial's primary objective is to demonstrate superiority of ATL in overall survival (OS), while confirming non-inferiority in health-related quality of life (QoL), measured by the global health status scale of the European Organisation for Research and Treatment of Cancer (EORTC) - Quality of Life Questionnaire Core 30 (QLQ-C30). Secondary outcomes include progression-free survival (PFS), seizure control, neurocognitive functioning, and longitudinal assessments of selected EORTC QLQ-C30 and BN20 domains. A total of 178 patients will be enrolled over three years, with a minimum follow-up of three years. An interim safety analysis after inclusion of 57 patients will assess functional outcome differences using the modified Rankin Scale (mRS) at 6 months postoperatively. The study is powered (\\>80%) to detect a survival benefit assuming a median OS increase from 17 to 27.5 months. If proven superior to GTR, ATL could emerge as the preferred surgical strategy for isolated temporal lobe glioblastoma, offering robust evidence in favor of extending supramarginal resection principles to the broader context of glioblastoma care.",[219,220],"Newly-diagnosed Glioblastoma","Temporal Lobe",[210,222,223,224,225],"ATLAS","NOA-29","Anterior temporal lobectomy","gross total resection","2025-06-07",{"date":228,"type":51},"2025-06-13",{"date":230,"type":51},"2024-11-28",{"date":232,"type":20},"2031-02-28",{"name":234,"class":122},"University Hospital, Bonn",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":254,"locationsCount":155},"100468482","early-phase-1-personalized-cancer-stem-cell-high-throughput-drug-screening-for-glioblastoma-100468482","NCT05380349","Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma","A Phase 1 Study of Combination Drug Therapy Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS) With Standard of Care for Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Histological diagnosis of GBM (WHO grade 4)\n* Subjects ≥18 years of age\n* Patients must have a life expectancy of \\>6 months\n* Patients must have a surgically accessible tumor with the intent for a gross or near total resection of the tumor mass (GBM, WHO grade 4)\n* Patients must have a KPS rating of ≥70\n* Patients should not have received any prior systemic anti-cancer therapy\n* Patients must be negative for HIV, Hepatitis B and C\n* Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:\n\n  * Hemoglobin (Hgb)\\> 8 g\u002FdL\n  * Absolute Neutrophil Count (ANC) \\> 1,000\u002Fmm3\n  * Platelet count \\> 100,000\u002Fmm3\n  * Creatinine \\\u003C 2 mg\u002FdL\n  * Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\\u003C 3x upper limit of normal (ULN)\n\nExclusion Criteria:\n\n* Metastatic disease\n* Diseases or conditions that obscure toxicity or dangerously alter drug metabolism\n* Serious intercurrent medical illness\n* Inadequately controlled hypertension\n* History of myocardial infarction or unstable angina within 6 months\n* History of stroke or transient ischemic attack within 6 months",{"count":243,"type":20},10,[245],"EARLY_PHASE1","Proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care radiation and TMZ.",[27],"2025-05-13",{"date":250,"type":51},"2025-05-16",{"date":252,"type":51},"2024-04-19",{"date":179,"type":20},{"name":255,"class":122},"Swedish Medical Center"]