[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544877":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":47,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Saint Petersburg State University, Russia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Treatment-naive patients with BRAF-negative anaplastic thyroid cancer and previously treated patients, including patients with BRAF-positive anaplastic thyroid cancer (resistant to anti-BRAF therapy).",[13],"Drug: Pembrolizumab + Lenvatinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pembrolizumab + Lenvatinib","Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody. Lenvatinib is Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ilya Sleptsov, MD","CONTACT","+7(921)951-70-88","newsurgery@yandex.ru",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Ernest Dzhelialov","+7(911)134-50-44","ernest.dzhelialov@gmail.com",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Saint Petersburg State University Hospital","RECRUITING","Saint Petersburg","190020","Russia","RU",{"type":40,"coordinates":41},"Point",[42,43],30.31413,59.93863,{"lat":43,"lon":42},[46],{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"type":48,"investigatorFullName":28,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100544877","phase-2-efficacy-of-pembrolizumab-and-lenvatinib-in-patients-with-anaplastic-thyroid-cancer-100544877",false,"NCT06374602","Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer","Inclusion Criteria:\n\n* immunohistochemically verified anaplastic thyroid cancer that is not eligible to R0-R1 surgery;\n* age ≥ 18 years;\n* functional status of ECOG 0-2;\n* adequate function of internal organs and bone marrow;\n* the ability to give written informed consent.\n\nExclusion Criteria:\n\n* patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF\u002FMEK inhibitors;\n* patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);\n* tumor invasion into large vessels;\n* patients with open wounds and fistulas;\n* contraindications to taking any of the studied drugs;\n* patients with poor functional status (ECOG 3-4);\n* continuous use of immunosuppressive therapy;\n* prior therapy with investigational drugs;\n* pregnancy, breast-feeding","ALL","18 Years",{"count":59,"type":60},20,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints.",[66],"Anaplastic Thyroid Cancer",[68,69,70,71,72],"Anaplastic thyroid cancer","Immunotherapy","Targeted therapy","Lenvatinib","Pembrolizumab","2025-08-29",{"date":75,"type":76},"2025-09-05","ACTUAL",{"date":78,"type":76},"2024-03-25",{"date":80,"type":60},"2026-06-25",{"name":5,"class":6},1]