[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519564":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":19,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":44,"responsibleParty":55,"collaborators":11,"id":58,"slug":11,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Cologne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"progression free survival",null,"1 year",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE",[20],{"label":21,"type":22,"description":23,"interventionNames":24},"Treatment","EXPERIMENTAL","Pembrolizumab + BrECADD",[25],"Drug: Pembrolizumab",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"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.",[21],[33],{"name":34,"affiliation":35,"role":36},"Peter Borchmann, Prof.","1st Department of Medicine, Cologne University Hospital","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Michael Fuchs","CONTACT","+49221478","88160","michael.fuchs@uk-koeln.de",[45],{"facility":35,"status":11,"city":46,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":11},"Cologne","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],6.95,50.93333,{"lat":53,"lon":52},{"type":36,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Prof. Dr. Peter Borchmann","Prof.","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":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"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",[76],"Hodgkin Lymphoma",[78,79,80],"advanced stage","first line treatment","PD-1 inhibitor","NOT_YET_RECRUITING","2025-04-02",{"date":84,"type":85},"2025-04-06","ACTUAL",{"date":87,"type":70},"2025-08",{"date":89,"type":70},"2029-01",{"name":5,"class":6},1]