[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-idh-isocitrate-dehydrogenase-wildtype\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-idh-isocitrate-dehydrogenase-wildtype":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,63,76,103,131,161,187,223,250],{"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":26,"conditions":27,"keywords":43,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053479","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100053479",false,"NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo craniotomy for brain biopsy and\u002For resection\n\n  --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able to achieve a gross total resection of tumor will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","ALL","18 Years","99 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioma","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","High Grade Glioma","Glioma, Malignant","Brain Cancer",[28,35,44,45,46,47,48,49,42],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":21},"2026-07-16",{"date":58,"type":21},"2032-12-31",{"name":60,"class":61},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":64,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":26,"conditions":67,"keywords":68,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":75,"locationsCount":62},"100624942",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],[28,35,44,45,46,47,48,49,42],"2026-07-01",{"date":71,"type":54},"2026-07-02",{"date":73,"type":21},"2026-07-07",{"date":58,"type":21},{"name":60,"class":61},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":62},"100643886","ttfields-plus-fet-pet-guided-stereotactic-radiosurgery-versus-ttfields-alone-for-recurrent-glioblastoma-tarrget-20-100643886","NCT07668869","TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)","Tumor Treating Fields (TTFields) Concomitant With Stereotactic Radiosurgery Based on FET-PET vs TTFields Alone for the Treatment of Recurrent, Glioblastoma (Tarrget 2.0)","Inclusion Criteria:\n\n* Age ≥18 years\n* Karnofsky Performance Status ≥70\n* Histologically confirmed IDH-wildtype glioblastoma\n* First, second, or third recurrence\n* Radiological recurrence according to RANO 2.0 criteria\n* Prior radiotherapy and temozolomide treatment\n* At least 6 months since completion of previous radiotherapy\n* Contrast-enhancing recurrent lesion visible on MRI\n* Maximum recurrent lesion diameter ≤5 cm\n* Available molecular profile including IDH and MGMT status\n* Adequate hematologic, renal, and hepatic function\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous bevacizumab treatment\n* Planned chemotherapy or targeted therapy after study intervention\n* Previous stereotactic re-irradiation within the planned treatment field\n* More than three recurrences\n* Significant psychiatric disorders\n* Significant unrelated neurological disease\n* Implanted pacemaker, defibrillator, deep brain stimulator, or other incompatible electronic device\n* Pregnancy or breastfeeding\n* Active intracranial hemorrhage\n* Uncontrolled hypertension\n* Severe renal dysfunction\n* Participation in another interventional study likely to interfere with this study",{"count":84,"type":21},92,[86],"NA","This study evaluates whether the addition of FET-PET-guided stereotactic radiosurgery (SRS) to Tumor Treating Fields (TTFields) improves survival outcomes in patients with recurrent IDH-wildtype glioblastoma.\n\nPatients with recurrent glioblastoma have limited treatment options and poor prognosis. TTFields is a non-invasive antimitotic therapy that has demonstrated efficacy in recurrent glioblastoma. Stereotactic radiosurgery is commonly used in selected patients with recurrent disease; however, treatment efficacy may be limited by the infiltrative nature of glioblastoma and challenges in accurate target delineation.\n\nThe study hypothesizes that combining TTFields with FET-PET-guided stereotactic radiosurgery will improve one-year overall survival compared with TTFields alone. Participants will be randomized in a 1:1 ratio to receive either TTFields plus stereotactic radiosurgery or TTFields alone.",[89,29,90],"Glioblastoma","Glioblastoma Multiforme, Adult",[92],"glioblastoma, TTF, SRS, radiosurgery, stereotactic radiotherapy","2026-06-19",{"date":95,"type":54},"2026-06-25",{"date":97,"type":54},"2025-12-30",{"date":99,"type":21},"2032-06",{"name":101,"class":102},"Prof. Franciszek Lukaszczyk Memorial Oncology Center","OTHER",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100498096","phase-1-a-study-of-debio-0123-in-combination-with-temozolomide-in-adult-participants-with-recurrent-or-progressive-glioblastoma-and-of-debio-0123-in-combination-with-temozolomide-and-radiotherapy-in-adult-participants-with-newly-diagnosed-glioblastoma-100498096","NCT05765812","A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","A Phase 1\u002F2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","Screening Inclusion Criteria for Phase 1 and Phase 2:\n\n* Signed written informed consent approved before undertaking any study-specific procedures.\n* Age ≥18 years of age.\n* Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.\n* Adequate bone marrow, hepatic, and renal function.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Willing to practice highly effective methods of contraception.\n* Life expectancy of at least 3 months in the best judgment of the Investigator.\n* Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n\nAdditional specific inclusion criteria for Phase 1 and Phase 2:\n\n• A maximum of 1 \\[for Phase 1 (Dose Expansion) and phase 2\\] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).\n\nNote: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers \\[GLIADEL®\\]) for first recurrence is allowed.\n\n* Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.\n* KPS ≥60.\n\nAdditional specific inclusion criteria for Phase 1 Arm A:\n\n* Participants must have one of the following histopathologically proven diagnoses (WHO 2021):\n* GBM Isocitrate dehydrogenase (IDH)-wildtype Grade 4 which may include secondary GBMs (i.e., those that progress from low-grade gliomas).\n* Astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific inclusion criteria for Phase 1 Arm B and C:\n\n* Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior treatment included surgery only.\n* KPS ≥70.\n\nAdditional specific inclusion criteria for Phase 1 dose expansion and Phase 2:\n\n• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021\n\nAdditional specific exclusion criteria for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific exclusion criteria for Phase 1 and Phase 2\n\n* Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.\n* Any anticancer treatment, monoclonal antibodies\u002Fbiologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.\n* Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ.\n* Prior exposure to any WEE1 inhibitor.\n* History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell\u002Fsquamous cell skin cancer) that have been treated with curative intent.\n* Left ventricular ejection fraction (LVEF) below 55%.\n\nAdditional specific exclusion criteria for Phase 1 Arm B and C:\n\n* Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.\n* Prior therapy that would result in an overlap of the radiation fields.\n\nAdditional specific exclusion criteria for Phase 1 dose expansion and Phase 2\n\n• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.\n\n\\[Note: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.\\]",{"count":111,"type":21},116,[24,25],"The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.\n\nThe primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development.\n\nThe Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.",[29,115],"Astrocytoma, Grade III",[117,118,119],"WEE1 inhibitor","Glioblastoma, IDH-wildtype, Grade 4, World Health Organization (WHO) 2021","Astrocytoma, IDH-mutant, Grade 3, WHO 2021","2026-06-11",{"date":122,"type":54},"2026-06-12",{"date":124,"type":54},"2023-05-15",{"date":126,"type":21},"2028-09",{"name":128,"class":129},"Debiopharm International SA","INDUSTRY",16,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100639003","phase-2-laser-interstitial-thermal-therapy-litt-with-cemiplimab-or-other-chemotherapy-in-recurrent-glioblastomas-100639003","NCT07620548","Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab or Other Chemotherapy in Recurrent Glioblastomas","A Randomized Phase II Study of the Efficacy of Laser Interstitial Thermal Therapy (LiTT) Combined With Cemiplimab Versus Physician's Choice Chemotherapy in Recurrent Glioblastomas","Inclusion Criteria:\n\n* Histologically confirmed WHO grade 4 GBM (IDH-wt). Note: GBM variants, including histone-mutant and molecular-defined gliomas per WHO 2021 are allowed. Any number of recurrences are permitted.\n* Unequivocal evidence of tumor progression as documented on the screening biopsy.\n* At least 12 weeks post-completion of standard frontline therapy. Standard frontline therapy in this population includes maximal feasible surgical resection (biopsy alone is allowed), radiotherapy, and temozolomide chemotherapy. There is no restriction on the number of adjuvant temozolomide cycles.\n* Candidate for LITT based on the size, location, and shape of the recurrent tumor as determined by the performing neurosurgeon. Surgical resection\u002Fdebulking prior to LITT is allowed per standard of care but is not required; if the patient undergoes resection or debulking, it must have occurred at least 3 weeks prior to the start of any study treatment.\n* At least 18 years of age.\n* Karnofsky performance status ≥ 60%\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n  * INR or PT ≤ 1.5 x IULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)\n  * aPTT ≤ 1.5 x IULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)\n* The effects of cemiplimab on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation (for patients in the Experimental Arm) OR 14 days after completion of study participation (for people of childbearing potential in the Control Arm) or 4 months (for people able to father a child in the Control Arm).\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received prior treatment with any anti-angiogenic agent (including bevacizumab) within 3 months of date of surgery (LITT). (Note: bevacizumab is otherwise permitted when used outside this window for cerebral edema.)\n* Received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD127, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Received prior treatment with a monoclonal antibody within 4 weeks prior to the first day of study treatment.\n* Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first day of study treatment.\n* Has not recovered (i.e., grade 1 or baseline) from adverse events caused by anti-cancer agents administered no more than 4 weeks prior to consent. Note: patients with ≤ grade 2 neuropathy are an exception to this criterion. Note: if a patient underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications prior to the first day of study treatment.\n* Candidate for curative resection or urgent surgical procedure(s) needed.\n* Presence of brainstem lesions or lesions that are \\\u003C 5 mm from the hypophysis or cranial nerves.\n* Multifocal glioma that is bilateral. Patients with unilateral multifocal gliomas may be eligible if their multifocal disease can be treated effectively and safely in a single LITT procedure. Note: Corpus callosal tumors are eligible even if they are bilateral as long as they satisfy the size and shape limits of LITT as determined by the performing neurosurgeon.\n* Presence of leptomeningeal metastases.\n* Recent (within 8 weeks) history of CNS hemorrhage unless the hemorrhage is located within the tumor that will be removed en total during surgical debulking or ablated during LITT.\n* Requires therapeutic doses of anticoagulants unless anticoagulation can be safely discontinued before surgery per standard practice or an IVC filter can be used in place of anticoagulation. Patients are permitted to resume anticoagulation following LITT at the discretion of their treating physician.\n* Received prior local therapy (stereotactic radiosurgery, brachytherapy, or carmustine wafers) to the proposed area of LITT.\n* Received a live vaccine or live-attenuated vaccine within 28 days prior to the first day of study treatment. Received COVID-19 vaccine within 7 days of first dose.\n* Currently receiving any other investigational agents or has participated in a study of an investigational agent or device within 3 weeks of the first day of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.\n* Dexamethasone \\> 4 mg at the time of consent.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (with the exception of daily dexamethasone ≤ 4 mg).\n* History of immune related pneumonitis or (non-infectious) interstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease in the last 5 years.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection or infection requiring hospitalization or treatment with IV anti-infectives within 14 days of first dose, myocardial infarction within 12 months of first dose, symptomatic congestive heart failure, unstable angina pectoris, acute coronary syndrome within 12 months of first dose, transient ischemic attack or stroke within 12 months of first dose, or cardiac arrhythmia. New York Heart Association Function Classification of class II, II, or IV are exclusionary.\n* Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Pregnant and\u002For breastfeeding. People of childbearing potential must have a negative pregnancy test within 14 days of study entry and again within 72 hours of initiation of cemiplimab (if applicable).\n* Active or latent tuberculosis.\n* History of HIV infection if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.",{"count":139,"type":21},99,[25],"This study will assess the therapeutic efficacy of the combination of Laser Interstitial Thermal Therapy (LiTT) with adjuvant cemiplimab compared to the therapeutic efficacy of the combination of LiTT with physician's choice of adjuvant chemotherapy in patients with recurrent glioblastoma. Patients will be enrolled and randomized on a 2:1 ratio to either the experimental arm (LiTT + cemiplimab) or the control arm (LiTT + physician\u002Fs choice chemotherapy).",[89,143,29],"Glioblastoma, IDH-wildtype",[38,145,146,147,89,148,149],"Recurrent","IDH-wt","IDH-wildtype","Immunotherapy","LiTT","NOT_YET_RECRUITING","2026-05-26",{"date":153,"type":54},"2026-06-02",{"date":155,"type":21},"2026-08-31",{"date":157,"type":21},"2032-08-31",{"name":159,"class":102},"Washington University School of Medicine",2,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100622621","phase-2-the-gliomax-study-mt027-allogeneic-car-t-for-recurrent-glioma-100622621","NCT07386002","The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma","A Phase II, Open-Label, Multicenter Study With a Safety Run-In to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of MT027 Administrated Intracerebroventricularly in Patients With Recurrent or Progressive Glioblastoma (WHO Grade 4)","GLIOMAX-101","Inclusion Criteria:\n\n* Patients must meet all the following inclusion criteria to be enrolled in the study (applied to all patients screened in safety run-in and dose expansion stage, unless specified):\n\n  1. Written informed consent must be obtained prior to any procedures that are not considered SOC\n  2. ≥ 18 years old and ≤ 70 years old on the day of signing informed consent, male or female\n  3. According to the WHO Classification of Tumors of the CNS (2021), definitely diagnosed recurrent or progressive GBM, WHO Grade 4, which must meet all 3 of the following criteria:\n\n     * According to the histological\u002Fmolecular pathology, diagnosed with GBM WHO grade 4\n     * According to the histopathology or radiological imaging, confirmed disease progression or recurrence\n     * First recurrence after failure to the SOC therapy of newly diagnosed disease-Stupp regimen (which was surgery + standard RT + concurrent TMZ and adjuvant TMZ), or first recurrence after failure to the SOC therapy of newly diagnosed disease-Stupp regimen (which was surgery + standard RT + concurrent TMZ and adjuvant TMZ) and received Bevacizumab treatment\n  4. Participants with either unresectable lesions, or with resectable lesions who have undergone prior surgical resection, or with resectable lesions and no planned reoperation within 3 months after enrollment based on Investigator's judgment\n  5. Participants voluntarily provide the latest archival tumor or fresh biopsies FFPE samples (at least 8 consecutive non-stained sections) for B7H3 expression test by Immunohistochemistry (IHC), and the clinical pathology confirms positive B7H3 expression, defined as the proportion of 2+ and 3+ ≥ 20% (Reference refer to Appendix 13.1) or historical B7H3 positive expression within 12 months at the time of enrollment\n  6. Karnofsky Performance Status (KPS) score ≥ 60\n  7. Life expectancy of ≥ 12 weeks\n  8. Adequate organ and marrow functions as defined below: (blood transfusion, blood component transfusion, or hematopoietic stimulating factors within 7 days prior to the first dose is not allowed)\n\n     1. Hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 90 g\u002FL\n     2. Hepatic: ALT and AST ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN\n     3. Renal: Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated Cr clearance ≥ 30.0 mL\u002Fmin using Cockcroft-Gault formula\n     4. Coagulation: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participant is receiving anticoagulant therapy in which case the APTT and INR must be within the therapeutic range of intended use for the anticoagulant)\n     5. Cardiac: Left ventricular ejection fraction (LVEF) \\> 50%\n     6. Oxygen saturation ≥ 95% on room air\n  9. Has adequate treatment washout period before IP treatment, defined as:\n\n     Major surgery : ≥ 2 weeks§; Ommaya reservoir placement surgery was excluded Radiation therapy : ≥ 12 weeks (unless the progression is clearly outside the radiation field (e.g., beyond the high-dose region or 80% isodose line) or there is pathologic confirmation of disease progression) Chemotherapy :≥ 23 days for TMZ ; ≥ 6 weeks for Nitrosoureas or Mitomycin C (such as: Carmustine, Lomustine and so on) Biologic agents\\* (such as: PD1\u002FPD-L1 antibodies) : ≥ 4 weeks Small molecule targeted drugs (TKIs such as Regorafenib and Anlotinib) : ≥ 3 weeks or 5 half-lives (including toxic metabolites), whichever is longer Other antitumor therapies :≥ 4 weeks\n\n     §Any surgery incisions or wounds must be completely healed\n\n     \\*Not including Bevacizumab\n  10. Intracranial hemorrhage Grade ≤ 1 (per NCI-CTCAE v5.0), and toxicity from previous systemic treatment returns to ≤ Grade 1 or baseline before the first CAR-T dose (except alopecia)\n  11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of the pre-study visit, through the course of the study and for 120 days after the last dose of study medication\n\n      * Female patients of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication\n      * Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year\n      * Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\nA patient meeting any of the following criteria is not eligible to participate in this study (applied to all patients screened in safety run-in and dose expansion stages, unless specified):\n\n1. Brainstem and thalamus recurrence, spinal cord dissemination or extracranial metastasis\n2. The largest diameter of a single tumor lesion \\> 5 cm, or the sum of the largest diameters of multiple lesions \\> 6 cm\n3. Symptoms and signs of chronic intracranial hypertension that are difficult to control with drugs (such as daily use of Mannitol \\> 500 mL or Dexamethasone \\> 15 mg or Methylprednisolone \\> 80 mg or other hormones at the same dose)\n4. Uncontrolled seizure or epilepsy aggravation requiring escalation of antiepileptic therapy over the last 4 weeks\n5. Participated in other therapeutic clinical trials within 4 weeks prior to screening\n6. Previously received other allogeneic tissue\u002Fsolid organ transplantation OR other CAR-T cell therapy\n7. Previously received Carmustine wafer, oncolytic viruses or other intratumoral implants treatment (e.g., GLIADEL® Wafer)\n8. Prior history of severe allergy to any component or biological product of the investigational drug\n9. History of other malignancy within 5 years of screening with the following exceptions: a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, c) carcinoma in situ of the breast, d) local prostate cancer after radical resection and\u002F or definitive RT with stable prostate specific antigen (PSA) levels for 1 year\n10. Serious diseases such as active systemic infection, coagulation dysfunction, history of interstitial lung disease, radiation pneumonitis, or evidence of active pneumonia that is not considered appropriate by Investigator\n11. Clinically significant uncontrolled heart, lung, liver, renal and neuro insufficiency including Class III or above heart failure according to the New York Heart Association (NYHA) standard, Stage IV liver cirrhosis; chronic kidney disease (CKD) Stage III or above; Symptoms of severe respiratory failure involving other organs; Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy\n12. History or active autoimmune diseases. However, participants with type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disease that do not require systemic treatment (vitiligo, psoriasis, or hair loss) may be allowed. For any uncertainty, it is recommended to consult the sponsor's medical monitor before signing the informed consent\n13. Received live vaccines within 2 weeks before the first IP treatment or plans to receive live vaccines during the study period\n14. Participants with a history of active pulmonary tuberculosis infection within 1 year, those participants with history more than 1 year prior to the first dose of IP may be considered suitable if there is no evidence of active pulmonary tuberculosis judged by Investigator\n15. Active hepatitis B virus infection or hepatitis C virus infection (defined as HCV-IgM antibody positive, if HCV-RNA is lower than the lower limit of detection, enrollment is allowed); Or human immunodeficiency virus (HIV) infection (defined as HIV antibody positive); Or positive in Treponema pallidum antibody test\n16. According to Investigator's judgment, the participant suffers from severe neurocognitive impairment\n17. Unable to safely undergo ICV injection related procedures\n18. Any disease that currently needs systemic steroid treatment\n19. Unavailable for the follow-up assessment or concern for participant's compliance with the protocol procedures\n20. Presence of any conditions that could, in the opinion of Investigator, compromise the participant's ability to participate in the study\n21. Subjects who are lactating -","70 Years",{"count":20,"type":21},[25],"This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK\u002F pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.\n\nEach participant will undergo screening, treatment (receiving MT027 at a dose of 3×10\\^7 cells), safety follow-up, and long-term follow-up periods.\n\nMT027 will be given via ICV injection on Day 1 \\& Day 15 of the first 28-day cycle. If the participant does not experience any unacceptable toxicities and disease progress in the first cycle, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \\& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.",[29],[175,176],"Recurrent or Progressive Glioblastoma","MT027","2026-02-06",{"date":179,"type":54},"2026-02-10",{"date":181,"type":21},"2026-06-30",{"date":183,"type":21},"2029-07-31",{"name":185,"class":129},"T-MAXIMUM Pharmaceutical Inc",4,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":197,"phases":4,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100601492","feasibility-of-oncohabitats-for-surgical-and-treatment-planning-in-idh-wildtype-glioblastoma-sinue-100601492","NCT07111195","Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)","Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)","SINUE","Inclusion Criteria:\n\n* Adults (≥18 years old) at the time of diagnosis\n* Radiological diagnosis of high-grade glioma\n* Candidates for surgical resection\n* Availability of complete preoperative MRI studies, including:\n* T1-weighted MRI (pre- and post-gadolinium)\n* T2-weighted MRI\n* FLAIR (Fluid-Attenuated Inversion Recovery)\n* T2\\*-weighted DSC perfusion MRI\n* Signed informed consent to participate in the clinical study\n\nExclusion Criteria:\n\n* Patients who do not provide informed consent\n* Patients deemed inoperable\n\nWithdrawal criteria:\n\n* MRI data that cannot be processed using ONCOhabitats\n* Patient withdraws informed consent at any time",{"count":196,"type":21},140,"OBSERVATIONAL","The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma.\n\nThe study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making.\n\nThe primary research questions are:\n\n* Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis?\n* Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy?\n\nParticipants will:\n\n* Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection\n* Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE)\n* Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations\n\nResearchers will analyze:\n\n* Imaging biomarkers (e.g., relative cerebral blood volume, rCBV)\n* Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression)\n* Clinical and survival outcomes\n\nThis study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.",[29],[89,201,202,203,204,205,206,207,208,209,210,211,212],"IHD-wildtype","MRI","Biomarkers","Perfussion","Tumor heterogenity","Peritumoral edema","Tumor Infiltration","Machine learning","Medical device validation","Immunosuppression","Overall survival","MGMT status","2025-07-31",{"date":215,"type":54},"2025-08-08",{"date":217,"type":54},"2024-07-16",{"date":219,"type":21},"2026-09",{"name":221,"class":102},"Juan M Garcia-Gomez",5,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":197,"phases":4,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":62},"100549162","study-of-metabolic-transcriptomic-and-proteomic-characteristics-in-relapsed-glioblastoma-100549162","NCT06430424","Study of Metabolic, Transcriptomic and Proteomic Characteristics in Relapsed Glioblastoma","Study of Metabolic, Genomic and Proteomic Modifications in Relapsed Glioblastoma. Identification or Prognostic Markers in Patients Undergoing Surgery for Relapsed Glioblastoma.","GBrecurr","Inclusion Criteria:\n\n* age \\> 18 years\n* surgery for both primary and recurrent glioblastoma between 2005 and 2023 at the CHU de Bordeaux\n\nExclusion Criteria:\n\n* systemic therapy received for non-glioblastoma tumor",{"count":20,"type":21},"Glioblastomas are the most frequent and aggressive malignant tumors of the CNS in adults, with almost systematic relapse despite treatment with surgery followed by radio-chemotherapy (STUPP protocol). The aim of this study is to better characterize transcriptomic, proteomic and metabolic changes in relapsed glioblastoma compared to the initial tumor, in order to identify new prognostic markers and potential new therapeutic targets.",[30,29],[235,236,237,238,239,240],"Recurrent glioblastoma","Prognostic","Metabolism","Proteomic","Transcriptomic","Microbiota","2025-07-29",{"date":243,"type":54},"2025-07-30",{"date":245,"type":54},"2024-04-05",{"date":247,"type":21},"2026-04",{"name":249,"class":102},"University Hospital, Bordeaux",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":270,"locationsCount":272},"100506821","phase-1-evaluation-of-eflornithine-plus-temozolomide-in-patients-with-newly-diagnosed-glioblastoma-or-astrocytoma-100506821","NCT05879367","Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A\u002FB intact) per WHO 2021 tumor classification.\n* Completed external beam radiation therapy per standard of care.\n* Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.\n* Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.\n* Willing to abstain from intercourse or use acceptable contraceptive methods.\n* If taking corticosteroids, must be on a stable or decreasing dose.\n\nExclusion Criteria:\n\n* Recent history of recurrent or metastatic cancer that could confound response assessments\n* Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).\n* Prior Optune treatment.\n* Active infection or serious intercurrent medical illness.\n* Poorly controlled seizures.\n* Significant cardiac disease within 6 months of enrollment.\n* Poorly controlled diabetes.\n* Use of another investigational agent within 30 days of enrollment.",{"count":258,"type":21},66,[24],"The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.",[143,89,32,29,38,262,263],"Astrocytoma","Astrocytoma, IDH-Mutant","2025-06-19",{"date":266,"type":54},"2025-06-25",{"date":268,"type":54},"2023-07-24",{"date":181,"type":21},{"name":271,"class":129},"Orbus Therapeutics, Inc.",8]