[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-glioblastoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100619637","phase-2-evaluation-of-ucpvax-vaccine---pembrolizumab-combined-with-standard-treatment-as-adjuvant-therapy-in-patients-with-unmethylated-mgmt-glioblastoma-100619637",false,"NCT07347210","Evaluation of UCPVax Vaccine +\u002F- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma","Evaluation of UCPVax Vaccine +\u002F- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma: a Randomized Phase II Trial","MATVAC-1","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 with informed consent signed\n2. Patient with a confirmed histological diagnosis of non-mutated IDH primary glioblastoma (surgical resection or biopsy).\n3. Tumor with unmethylated MGMT promoter status\n4. Patients having completed the concomitant phase of radiotherapy + temozolomide regimen (standard radiotherapy with 60 Gy in 30 fractions or hypofractionated radiotherapy with 40 Gy in 15 fractions), and eligible for the 6 monthly cycles of maintenance temozolomide\n5. Karnofsky Perfomance status (KPS) ≥ 70%\n6. Life expectancy ≥ 3 months\n7. If patient is treated by corticosteroïds (CS), patient must be on stable CS dose for 15 days and total daily dose ≤ 10 mg prednisone, or equivalent\n8. Adequate organ function laboratory values\n9. Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening :\n\n   * Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\n   * Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\n   * Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but tubal ligation.\n\n   Female with childbearing potential must use effective contraception during study treatment and after the end of treatment based on the last study drug administrated: 6 months after the last dose of Temozolomide; 4 months after the last dose of pembrolizumab and 1 month after the last injection of UCPVax.\n10. Male patients with a female partner of childbearing potential should be willing to use barrier contraception and to refrain from donating sperm during the study and and post-treatment based on the last study drug administrated: 3 months after the last dose of temozolomide; 4 months after the last pembrolizumab dose; 1 month after the last UCPVax injection.\n11. Patient affiliated to or beneficiary of French social security system\n12. Ability to comply with the study protocol, in the Investigator's judgment.\n13. Signed and dates informed consent\n\nExclusion Criteria:\n\nPatients will not be eligible for this study for any of the following reasons:\n\nCancer specific exclusion criteria:\n\n1. IDH1 or IDH2 mutated tumor\n2. Presence of extracranial metastasis\n3. Leptomeningeal disease on MRI\n4. Contrast enhancement ≥4 cm (largest diameter on axial T1 sequences) on inclusion MRI\n5. Previous treatment with Carmustine impregnated wafers (GliadelR)\n6. Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists\n7. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study.\n\n   Non-eligible to treatment by UCPVax:\n8. Prior therapy with an anti-PD-1, anti-PD-L1, or with an agent directed to another immune checkpoint (e.g. CTLA-4, TIGIT, Lag3…).\n9. Immunosuppressive treatment including CS \\> 10 mg prednisone or equivalent within the previous 2 weeks\n10. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n11. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n12. History of tuberculosis infection\n13. History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n14. Active auto-immune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroïds or immunosuppressors). Replacement therapy (e.g. thyroxine, insulin) is allowed.\n15. Active or history of auto-immune disease or immune deficiency\n16. History of solid organ transplant nor allogenic hematopoietic stem cell transplantation\n17. Hypersensitivity to the active substance temozolomide or to any of the excipients listed (anhydrous lactose, colloidal anhydrous silica, sodium carboxymethyl starch type A, tartaric acid, stearic acid),\n18. Hypersensitivity to dacarbazine (DTIC)\n19. Hypersensitivity to the active substance pembrolizumab or to any of the excipients listed (L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80 (E433))\n20. Hypersensitivity to the active substance Montanide\n21. 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\n22. Inadequate hematology and organ functions; known cardiac failure or unstable coronaropathy, respiratory failure or another life threatening condition.\n23. Patient with unresolved non-hematologic toxicities \\> Grade 1 (or \\> Grade 2 if deemed acceptable by the investigator and not considered a safety risk)\n24. Major surgery within 1 month prior randomization or planned during the study\n25. Vaccination with alive attenuated vaccine within 4 weeks prior the first dosing. Patient must agree not to receive live attenuated vaccine including influenza vaccine during the treatment and within 6 months following the last dose of pembrolizumab\n\n    Non-eligible to a clinical trial:\n26. Diagnosis of another malignant tumor within 2 years before randomization except treating resected basocellular carcinoma and carcinoma in situ such as breast cancer, endometrial or cervical carcinoma that have undergone curative therapy.\n27. Current or treatment with another investigational drug within the previous 4 weeks.\n28. Breast-feeding or pregnant women, no effective contraception if risk of conception exists (up to 4 months after end of chemotherapy)","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Glioblastomas (GBM) are the most frequent brain tumors and one of the most lethal adult cancers despite maximal multimodal therapy. Despite maximal safe resection followed by radiotherapy and temozolomide (TMZ) ± tumor-treating fields, median overall survival for newly diagnosed GBM remains around 18 months and long-term survival is rare, and recurrence is nearly universal. So, the development of new therapeutic strategies is a critical unmet need in GBM.\n\nDespite the limited success of anti-PD(L)-1 therapy, immunotherapy remains a promising option in GBM. Current challenge supports to develop combinatorial therapy approaches considering the particular immune tumor microenvironment in GBM. Anticancer vaccines have shown promising signs of efficacy in GBM but critical factors challenge their efficacy. CD4 T help is of major interest for cancer vaccine effectiveness and for immune checkpoint inhibitors success. We previously designed UCPVax a CD4 T helper-targeted cancer vaccine derived from telomerase (TERT), a very attractive GBM-associated antigen (Adotévi O, J Clin Oncol 2023 ; Laheurte C, Cell Report Med 2025). The induction of robust tumor reactive CD4 T cell response with UCPVax together with TMZ-mediated immune effects will promote recruitment of effectors immune cells into tumor bed creating a more suitable microenvironment for anti-PD-1 action.\n\nThis is a proof-of-concept phase II trial to evaluate the efficacy of maintenance therapy evaluating UCPVax +\u002F- pembrolizumab combined to standard treatment in newly diagnosed unmethylated MGMT glioblastoma. A translational research network will be implemented to better understand the therapeutic efficacy of this combination.",[27],"Primary Glioblastoma",[29,30,31,32,33,34],"GBM","UCPVax","pembrolizumab","cancer vaccine","telomerase","CD4 T cell","NOT_YET_RECRUITING","2026-01-08",{"date":38,"type":39},"2026-01-16","ACTUAL",{"date":41,"type":21},"2026-01",{"date":43,"type":21},"2029-07",{"name":45,"class":46},"Centre Hospitalier Universitaire de Besancon","OTHER",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100446992","phase-3-av-gbm-1-vs-control-as-adjunctive-therapy-following-surgery-and-rttmz-in-newly-diagnosed-gbm-100446992","NCT05100641","AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT\u002FTMZ in Newly Diagnosed GBM","Randomized Phase 3 Trial of Standard Care Plus AV-GBM-1 vs Autologous Monocytes as Adjunctive Therapy Following Primary Surgery Plus Concurrent Radiation-temozolomide in Patients With Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* For tumor collection: Age \\>18, Presumptive diagnosis of primary GBM with plans for surgical resection, Written informed consent to provide tumor and blood and intent to proceed with leukapheresis\n* For randomization: Confirmation of GBM histology, AIVITA Biomedical confirmation of established cancer cell line and sufficient monocytes derived from PBMC during leukapheresis collection, age 70 years or greater or less than 70, KPS 90 or 100 vs 70 or 80, MGMT promotor methylation classified as positive or negative, IDH mutation classified as mutated or wild-type, and planning to initiate RT\u002FTMZ. Written informed consent for randomization and treatment per protocol\n\nExclusion Criteria:\n\n* For tumor collection: Prior history of astrocytoma or other glial tumor, Known autoimmune disease or immunodeficiency. Diagnosis of any other invasive cancer or disease process considered to be life-threatening within the next 5 years. Known allergy to GM-CSF\n* For randomization: Active infection or other active medical condition that could be life-threatening, Diagnosis of underlying cardiac disease that requires active medical treatment, Pregnant, Enrolled in another investigational trial to receive an investigational treatment, KPS \\\u003C 70, Did not meet inclusion\u002Fexclusion criteria for tumor collection",{"count":56,"type":21},672,[58],"PHASE3","This is a multi-center, double-blind, 2:1 randomized phase III trial to determine whether the addition of AV-GBM-1, a therapeutic, patient-specific dendritic cell vaccine, to standard therapy increases OS of patients with a recent diagnosis of primary GBM.\n\nThe intent is to enroll approximately 726 patients for tumor collection to enroll 690 who are eligible for treatment at the time of randomization and who have granted consent for participation. Because of the lack of toxicity, there are no restrictions related to performance status or blood tests at the time of treatment. The key endpoint is OS from date of first injection after RT\u002FTMZ; secondary endpoints are PFS from date of first injection, and OS and PFS from date of randomization prior to RT\u002FTMZ. Date of PFS will be determined by the principal investigator at each site.",[27],"2023-04-07",{"date":63,"type":39},"2023-04-10",{"date":65,"type":21},"2024-01",{"date":67,"type":21},"2029-03",{"name":69,"class":70},"Aivita Biomedical, Inc.","INDUSTRY"]