[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625449":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":38,"overallOfficials":18,"centralContacts":52,"locations":58,"responsibleParty":79,"collaborators":18,"id":81,"slug":18,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":18,"enrollmentInfo":90,"targetDuration":18,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) According to irRECIST","Objective response will be assessed using CT or PET\u002FCT imaging and evaluated according to irRECIST criteria. The outcome will be reported as the proportion (%) of participants achieving complete response (CR) or partial response (PR).","Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)",[14],{"measure":15,"description":16,"timeFrame":17},"PD-L1 Expression in Tumor Tissue (Immunohistochemistry, H-score or % Positive Cells)","PD-L1 expression in tumor tissue will be assessed using immunohistochemistry (IHC). The outcome will be reported as PD-L1 expression level (H-score and\u002For percentage of PD-L1 positive tumor cells) and correlated with objective response according to irRECIST.","Baseline",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":6,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NON_RANDOMIZED","PARALLEL","Non-randomized comparative study evaluating response to immune checkpoint inhibitors in first-line treatment of metastatic melanoma and association with PD-L1 expression in tumor tissue and blood.",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","This study evaluates the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and investigates the predictive value of PD-L1 expression in tumor tissue and blood. The aim is to assess the association 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 treatment with immune checkpoint inhibitors. In addition, the study evaluates the association between the occurrence of immune-related adverse events and survival.",[27,33],{"label":28,"type":6,"description":29,"interventionNames":30},"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.",[31,32],"Drug: Pembrolizumab","Drug: Nivolumab",{"label":34,"type":6,"description":35,"interventionNames":36},"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.",[32,37],"Drug: Ipilimumab",[39,44,48],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":18},"DRUG","Pembrolizumab","PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.",[28],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"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.",[34,28],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":18},"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.",[34],[53],{"name":54,"role":55,"phone":56,"phoneExt":18,"email":57},"Tanja Mesti, MD","CONTACT","+386 1 587 9000","tmesti@onko-i.si",[59],{"facility":5,"status":60,"city":61,"state":18,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":66,"coordinates":67},"Point",[68,69],14.50513,46.05108,{"lat":69,"lon":68},[72,76],{"name":73,"role":55,"phone":74,"phoneExt":18,"email":75},"Klavdija Korošec","+386 31630065","kkorosec@onko-i.si",{"name":77,"role":55,"phone":18,"phoneExt":18,"email":78},"Neža Gros","ngros@onko-i.si",{"type":80,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98,99],"Metastatic Melanoma","Skin Cancer",[101,102],"Immunotherapy","Immune Checkpoint Inhibitors","2026-02-13",{"date":105,"type":106},"2026-02-20","ACTUAL",{"date":108,"type":106},"2022-03-01",{"date":110,"type":92},"2028-03-31",{"name":5,"class":6},1]