[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471771":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL",null,[13],"Combination Product: Atezolizumab + FSRT radiation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"COMBINATION_PRODUCT","Atezolizumab + FSRT radiation","Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy",[9],[21],{"name":22,"affiliation":23,"role":24},"Alexander Stessin, MD","Stony Brook Cancer Center","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Sumbul Yousafi, MS","CONTACT","631-508-2212","sumbul.yousafi@stonybrookmedicine.edu",{"name":22,"role":28,"phone":32,"phoneExt":11,"email":33},"631-638-1000","alexander.stessin@stonybrookmedicine.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Stony Brook University Hospital","RECRUITING","Stony Brook","New York","11794","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-73.14094,40.92565,{"lat":47,"lon":46},[50,53],{"name":51,"role":28,"phone":52,"phoneExt":11,"email":33},"Alexander M Stessin, MD","631-444-2200",{"name":54,"role":28,"phone":55,"phoneExt":11,"email":56},"Caterina Vacchi-Suzzi, PhD","631-216-2993","caterina.vacchi-suzzi@stonybrookmedicine.edu",{"type":24,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Alexander Stessin","Professor of Medicine",[61],{"name":62,"class":63},"Genentech, Inc.","INDUSTRY","100471771","early-phase-1-atezolizumab-and-pre-surgical-brain-radiation-therapy-for-glioblastoma-multiforme-100471771",false,"NCT05423210","Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme","A Pilot Study to Evaluate the Immunogenic Effects of Window-of-Opportunity Fractionated Stereotactic Radiotherapy Combined With Atezolizumab for Patients With Newly Diagnosed WHO CNS Grade 4 Glioma (Glioblastoma Multiforme)","Inclusion Criteria:\n\n* Diagnosis of glioblastoma multiforme WHO Grade IV\n* The patient is a surgical candidate, with the surgical intent for a \\> 80% resection of the lesion\n* Negative pregnancy test\n* ECOG status \\\u003C= 2\n* Tumor volume \\\u003C= 3.5 cm\n* Adequate organ function\n* Negative for infectious disease (human immunodeficiency virus, Hepatitis B Virus, Hepatitis C Virus, tubercolosis)\n\nExclusion Criteria:\n\n* Patient already underwent surgical total or partial tumor resection, or radiation therapy\n* Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, bilateral cerebral hemisphere involvement (\"butterfly\" gliomas)\n* Patients at increased risk of neurologic decompensation\n* Continued use of high dose intravenous or oral corticosteroids, or \\> 8milligrams per day of systemic dexamethasone\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled or symptomatic hypercalcemia\n* History of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis\n* Significant cardiovascular disease\n* History of other malignancy within 1 year prior to screening\n* Severe infection within 4 weeks prior to initiation of study treatment\n* History of allogeneic stem cell or organ transplant\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies\n* Treatment with systemic immunostimulatory agents\n* Treatment with systemic immunosuppressive medication","ALL","18 Years",{"count":74,"type":75},12,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.",[81],"Glioblastoma Multiforme","2025-12-15",{"date":84,"type":85},"2025-12-22","ACTUAL",{"date":87,"type":85},"2022-10-25",{"date":89,"type":75},"2029-08",{"name":5,"class":6},1]