[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519564":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":44,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Cologne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Pembrolizumab + BrECADD",[13],"Drug: Pembrolizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pembrolizumab","As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and BrECADD (P-BrECADD). Response to induction therapy will be measured after 1x P (PET-1) and after 1x P + 2x P-BrECADD (PET-3).\n\nFurther systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two further cycles of P-BrECADD while participants with a positive PET-3 will receive four further cycles of P-BrECADD. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Peter Borchmann, Prof.","1st Department of Medicine, Cologne University Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Michael Fuchs","CONTACT","+49221478","88160","michael.fuchs@uk-koeln.de",[34],{"facility":24,"status":20,"city":35,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":20},"Cologne","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],6.95,50.93333,{"lat":42,"lon":41},{"type":25,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Prof. Dr. Peter Borchmann","Prof.","100519564","phase-2-pembrolizumab-in-first-line-treatment-of-advanced-stage-classical-hodgkin-lymphoma-100519564",false,"NCT06045195","Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma","Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma","Pembro-FLASH","Main Inclusion Criteria:\n\n* age 18-60\n* advanced stage classical Hodgkin Lymphoma\n* no previous treatment for cHL\n\nMain Exclusion Criteria:\n\n* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma\n* Chemotherapy or radiotherapy in medical history\n* Prior or concurrent disease that prevents treatment according to protocol","ALL","18 Years","60 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year PFS rate after treatment with one dose of pembrolizumab followed by four to six cycles of chemo-immunotherapy with P-BrECADD, and PET-guided radiotherapy as per standard of care",[66],"Hodgkin Lymphoma",[68,69,70],"advanced stage","first line treatment","PD-1 inhibitor","NOT_YET_RECRUITING","2025-04-02",{"date":74,"type":75},"2025-04-06","ACTUAL",{"date":77,"type":60},"2025-08",{"date":79,"type":60},"2029-01",{"name":5,"class":6},1]