[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625449":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":40,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"PD-1 inhibitor therapy","Participants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice.",[12,13],"Drug: Pembrolizumab","Drug: Nivolumab",{"label":15,"type":6,"description":16,"interventionNames":17},"Combination PD-1 and CTLA-4 inhibitor therapy","Participants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice.",[13,18],"Drug: Ipilimumab",[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pembrolizumab","PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Nivolumab","Nivolumab is a PD-1 immune checkpoint inhibitor administered as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice, either as monotherapy or in combination with ipilimumab.",[15,9],{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Ipilimumab","Ipilimumab is a CTLA-4 immune checkpoint inhibitor administered in combination with nivolumab as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice.",[15],[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Tanja Mesti, MD","CONTACT","+386 1 587 9000","tmesti@onko-i.si",[41],{"facility":5,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":48,"coordinates":49},"Point",[50,51],14.50513,46.05108,{"lat":51,"lon":50},[54,58],{"name":55,"role":37,"phone":56,"phoneExt":25,"email":57},"Klavdija Korošec","+386 31630065","kkorosec@onko-i.si",{"name":59,"role":37,"phone":25,"phoneExt":25,"email":60},"Neža Gros","ngros@onko-i.si",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100625449","immunotherapy-efficacy-and-pd-l1-as-a-predictive-biomarker-in-metastatic-melanoma-in-slovenia-100625449",false,"NCT07422779","Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia","Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood","MAK","Inclusion Criteria:\n\n* Age ≥18 years\n* Cytologically or histologically confirmed metastatic malignant melanoma\n* Stage IIID unresectable or stage IV (AJCC 8th edition)\n* ECOG performance status 0-2\n* First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab\u002Fnivolumab)\n* CT\u002FPET-CT performed within 4 weeks prior to treatment start\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous systemic therapy for melanoma\n* ECOG performance status 3-4\n* Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)\n* Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence \\>3 years)","ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.",[81,82],"Metastatic Melanoma","Skin Cancer",[84,85],"Immunotherapy","Immune Checkpoint Inhibitors","2026-02-13",{"date":88,"type":89},"2026-02-20","ACTUAL",{"date":91,"type":89},"2022-03-01",{"date":93,"type":75},"2028-03-31",{"name":5,"class":6},1]