[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650067":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Participants receive pembrolizumab 200 mg IV, every 3 weeks, times 2 infusions followed by lymph node dissection, followed by no adjuvant treatment.",[13],"Drug: Pembrolizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B","Participants receive ipilimumab (3 mg\u002Fkg) plus nivolumab (1 mg\u002Fkg) x one infusion, followed by a single infusion of nivolumab 240 mg IV 3 weeks later, followed by lymph node dissection, followed by no adjuvant treatment",[18],"Drug: Ipilimumab plus nivolumab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pembrolizumab","Pembrolizumab 200 mg IV, every 3 weeks",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Ipilimumab plus nivolumab","Single infusion of concurrent ipilimumab (3 mg\u002Fkg) plus nivolumab (1 mg\u002Fkg) followed by a single infusion of nivolumab 240 mg IV 3 weeks later",[15],[31],{"name":32,"affiliation":5,"role":33},"Stergios Moschos, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Claire Kowalczyk","CONTACT","919-984-0000","claire_kowalczyk@med.unc.edu",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Alexandra V Romfoe","alexandra_romfoe@med.unc.edu",[44],{"facility":45,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27599","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-79.05584,35.9132,{"lat":55,"lon":54},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100650067","phase-2-neoadjuvant-spare-adjuvant-nasa-in-stage-iiib-iv-m1a-melanoma-100650067",false,"NCT07740941","NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma","NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma","Inclusion Criteria:\n\n* Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status of 0-2.\n* Histological confirmation of cutaneous melanoma or melanoma of unknown primary.\n* AJCC stage IIIB\u002FIVa resectable disease that is measurable by iRECIST criteria.\n* Adequate hematologic, renal, hepatic, and heart function\n\nExclusion Criteria:\n\n* Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).\n* Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he\u002Fshe were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.","ALL","18 Years",{"count":69,"type":70},55,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.",[76,77,78,79],"Melanoma (Skin Cancer)","Melanoma Stage Stage IIIB","Melanoma Stage M1","Melanoma Stage IV",[81,82,83],"Programmed cell death Protein 1 inhibitor","pembrolizume","ipilimumab","NOT_YET_RECRUITING","2026-08-03",{"date":87,"type":88},"2026-08-05","ACTUAL",{"date":87,"type":70},{"date":91,"type":70},"2029-03",{"name":5,"class":6},1]