[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654161":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":18,"armGroups":16,"interventions":16,"overallOfficials":19,"centralContacts":24,"locations":16,"responsibleParty":30,"collaborators":16,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":16,"enrollmentInfo":42,"targetDuration":16,"studyType":45,"phases":16,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":52,"whyStopped":16,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":16},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival Rate","The progression-free survival (PFS) rate will be evaluated to identify clinical and\u002For biological predictive markers of efficacy of first-line immune checkpoint inhibitor (ICI) therapy in patients with metastatic melanoma treated at the European Institute of Oncology (IEO), receiving either ICI monotherapy (pembrolizumab or nivolumab) or ICI combination therapy (nivolumab plus ipilimumab or nivolumab plus relatlimab).","through study completion, an average of 1 year",[14],{"measure":15,"description":15,"timeFrame":12},"Real-world Overall Survival",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":6,"timePerspective":6,"maskingInfo":16},"The study will include patients who received an immune checkpoint inhibitors agent for their metastatic melanoma from 01\u002F01\u002F2022 until 30\u002F11\u002F2027 at IEO, Milan.",[20],{"name":21,"affiliation":22,"role":23},"Christian Blank, MD","Istituto Europeo di Oncologia","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":16,"email":29},"Gabriele Antonarelli, MD","CONTACT","+39 02 57489265","gabriele.antonarelli@ieo.it",{"type":31,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100654161","markers-of-efficacy-to-immunotherapy-in-patients-with-metastatic-melanoma-100654161",false,"NCT07794501","Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma","Identifying Markers of Efficacy to Immunotherapy in Patients With Metastatic Melanoma: the PREMIO Study","PREMIO","Inclusion Criteria:\n\n* Patients with a diagnosis of metastatic or locally advanced unresectable melanoma\n* Patients treated with first-line immunotherapy as monotherapy (e.g., pembrolizumab or nivolumab) or in combination (e.g., ipilimumab - nivolumab or nivolumab - relatlimab)\n* Patients treated at IEO (Milan) from 01\u002F01\u002F2022 to 30\u002F11\u002F2027\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Patients who received targeted therapy as first-line treatment for metastatic melanoma\n* Patients with a diagnosis of resectable stage III melanoma or operated stage IV with no evidence of disease (NED)","ALL","18 Years",{"count":43,"type":44},200,"ESTIMATED","OBSERVATIONAL","Cutaneous melanoma is an aggressive malignancy with a rising global incidence; its prognosis has been radically transformed by immune checkpoint inhibitors (ICIs), a class of immunotherapeutic agents targeting immune regulatory pathways such as programmed cell death protein 1 (PD-1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and lymphocyte activation gene 3 (LAG-3). Currently approved first-line treatment strategies-including anti-PD-1 monotherapy and the combinations of nivolumab plus ipilimumab and nivolumab plus relatlimab-have demonstrated significant survival benefits, although combination regimens are associated with a considerably more burdensome toxicity profile compared with monotherapy. Despite these major therapeutic advances, the optimal treatment choice for each individual patient remains uncertain, primarily due to the lack of validated predictive biomarkers in the metastatic setting. This unmet clinical need represents the central rationale of the present study, which aims to bridge this gap through the systematic collection and integrated analysis of clinical, pathological, and molecular data from approximately 200 patients treated with first-line immunotherapy at the European Institute of Oncology.",[48],"Metastatic Melanoma",[50,51],"Immunotherapy","Mestastatic melanoma","NOT_YET_RECRUITING","2026-08-28",{"date":55,"type":56},"2026-08-31","ACTUAL",{"date":58,"type":44},"2026-08-27",{"date":60,"type":44},"2027-11-30",{"name":5,"class":6}]