[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618049":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":42,"responsibleParty":251,"collaborators":35,"id":253,"slug":254,"hasResults":255,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":35,"eligibilityCriteria":259,"healthyVolunteers":255,"sex":260,"minAge":261,"maxAge":35,"enrollmentInfo":262,"targetDuration":35,"studyType":265,"phases":266,"briefSummary":268,"conditions":269,"keywords":277,"overallStatus":45,"whyStopped":35,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},{"fullName":5,"class":6},"Black Diamond Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"silevertinib and temozolomide","EXPERIMENTAL","silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg\u002Fm2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles",[13],"Drug: silevertinib in combination with temozolomide",{"label":15,"type":16,"description":17,"interventionNames":18},"temozolomide","ACTIVE_COMPARATOR","temozolomide 150-200 mg\u002Fm2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles",[19],"Drug: temozolomide (TMZ)",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","silevertinib in combination with temozolomide","Participants enrolled into Part 1 (Safety Lead-In) or randomized to Arm A in Part 2 will receive silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg\u002Fm2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles.",[9],[27,28,29],"BDTX-1535","Temodar","TMZ",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"temozolomide (TMZ)","Participants randomized to Arm B will receive temozolomide 150-200 mg\u002Fm2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles",[15],[29,28],null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Black Diamond Therapeutics Clinical Trial Navigation Service","CONTACT","(866) 955-4397","blackdiamondtx@careboxhealth.com",[43,62,77,92,107,121,136,151,165,180,193,207,222,236],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Highlands Oncology Group","RECRUITING","Springdale","Arkansas","72762","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-94.12881,36.18674,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":35,"email":61},"Shelly Farrow, RN","479-872-8130","sfarrow@hogonc.com",{"facility":63,"status":45,"city":64,"state":65,"zip":66,"country":49,"countryCode":50,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Cedars-Sinai Medical Center","Los Angeles","California","90048",{"type":52,"coordinates":68},[69,70],-118.24368,34.05223,{"lat":70,"lon":69},[73],{"name":74,"role":39,"phone":75,"phoneExt":35,"email":76},"Shannon Cyhan, RN, BSN, CCRC","310-248-7855","shannon.cyhan@cshs.org",{"facility":78,"status":45,"city":79,"state":80,"zip":81,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Yale Cancer Center","New Haven","Connecticut","06510",{"type":52,"coordinates":83},[84,85],-72.92816,41.30815,{"lat":85,"lon":84},[88],{"name":89,"role":39,"phone":90,"phoneExt":35,"email":91},"Amy Rodrigues","203-260-9632","amy.rodrigues@yale.edu",{"facility":93,"status":45,"city":94,"state":95,"zip":96,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Miami Cancer Institute","Miami","Florida","33176",{"type":52,"coordinates":98},[99,100],-80.19366,25.77427,{"lat":100,"lon":99},[103],{"name":104,"role":39,"phone":105,"phoneExt":35,"email":106},"Anais Vega","786-527-8861","Anais.Vega@baptisthealth.net",{"facility":108,"status":45,"city":109,"state":95,"zip":110,"country":49,"countryCode":50,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Moffitt Cancer Center","Tampa","33612",{"type":52,"coordinates":112},[113,114],-82.45843,27.94752,{"lat":114,"lon":113},[117],{"name":118,"role":39,"phone":119,"phoneExt":35,"email":120},"Carie Bliss","813-745-2131","Carie.Bliss@moffitt.org",{"facility":122,"status":45,"city":123,"state":124,"zip":125,"country":49,"countryCode":50,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Washington University School of Medicine Siteman Cancer Center","St Louis","Missouri","63108",{"type":52,"coordinates":127},[128,129],-90.19789,38.62727,{"lat":129,"lon":128},[132],{"name":133,"role":39,"phone":134,"phoneExt":35,"email":135},"Kelsey Etter","314-273-0656","etter@wustl.edu",{"facility":137,"status":45,"city":138,"state":139,"zip":140,"country":49,"countryCode":50,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"John Theurer Cancer Center at Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":52,"coordinates":142},[143,144],-74.04347,40.88593,{"lat":144,"lon":143},[147],{"name":148,"role":39,"phone":149,"phoneExt":35,"email":150},"Oncology Clinical Research Referral Office","551-996-1777","OncologyResearchReferral@hmhn.org",{"facility":152,"status":45,"city":153,"state":139,"zip":154,"country":49,"countryCode":50,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Atlantic Health","Summit","07901",{"type":52,"coordinates":156},[157,158],-74.36468,40.71562,{"lat":158,"lon":157},[161],{"name":162,"role":39,"phone":163,"phoneExt":35,"email":164},"Samantha Caulfield, RN","908-598-6561","Samantha.caulfield@atlantichealth.org",{"facility":166,"status":45,"city":167,"state":168,"zip":169,"country":49,"countryCode":50,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Northwell Health Center for Advanced Medicine - Brain Tumor Center","Lake Success","New York","11042",{"type":52,"coordinates":171},[172,173],-73.71763,40.77066,{"lat":173,"lon":172},[176],{"name":177,"role":39,"phone":178,"phoneExt":35,"email":179},"Center for Advanced Medicine - Brain Tumor Center","516-253-7753","neurosurgeryresearch@northwell.edu",{"facility":181,"status":45,"city":168,"state":168,"zip":182,"country":49,"countryCode":50,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Columbia University Irving Medical Center","10032",{"type":52,"coordinates":184},[185,186],-74.00597,40.71427,{"lat":186,"lon":185},[189],{"name":190,"role":39,"phone":191,"phoneExt":35,"email":192},"Denisse Mirauti","(212) 304-7991","dt2684@cumc.columbia.edu",{"facility":194,"status":45,"city":195,"state":168,"zip":196,"country":49,"countryCode":50,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Montefiore Medical Center","The Bronx","10461",{"type":52,"coordinates":198},[199,200],-73.86641,40.84985,{"lat":200,"lon":199},[203],{"name":204,"role":39,"phone":205,"phoneExt":35,"email":206},"Yoko Eng","718-405-8516","yeng@montefiore.org",{"facility":208,"status":45,"city":209,"state":210,"zip":211,"country":49,"countryCode":50,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center","Philadelphia","Pennsylvania","19107",{"type":52,"coordinates":213},[214,215],-75.16362,39.95238,{"lat":215,"lon":214},[218],{"name":219,"role":39,"phone":220,"phoneExt":35,"email":221},"Community Research Operations & Enrollment","215-600-9151","ONCTrialNow@jefferson.edu",{"facility":223,"status":45,"city":224,"state":210,"zip":225,"country":49,"countryCode":50,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"UPMC Hillman Cancer Center","Pittsburgh","15232",{"type":52,"coordinates":227},[228,229],-79.99589,40.44062,{"lat":229,"lon":228},[232],{"name":233,"role":39,"phone":234,"phoneExt":35,"email":235},"Linda Elias","412-623-6037","eliaslj@upmc.edu",{"facility":237,"status":45,"city":238,"state":239,"zip":240,"country":49,"countryCode":50,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Prisma Health","Greenville","South Carolina","29605",{"type":52,"coordinates":242},[243,244],-82.39401,34.85262,{"lat":244,"lon":243},[247],{"name":248,"role":39,"phone":249,"phoneExt":35,"email":250},"Kim Williams","864-522-431","Kim.Williams3@Prismahealth.org",{"type":252,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":263,"type":264},162,"ESTIMATED","INTERVENTIONAL",[267],"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?",[270,271,272,273,274,275,276],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","GBM","Glioblastoma Multiforme (GBM)","Glioma","Central Nervous System Diseases","Brain Cancer",[278,279,280,281,282,15,28,283,27,284,285,286,287],"EGFR","Glioblastoma","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","silevertinib","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)","2026-06-18",{"date":290,"type":291},"2026-06-22","ACTUAL",{"date":293,"type":291},"2026-05-05",{"date":295,"type":264},"2029-03",{"name":5,"class":6},14]