[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562165":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":61,"studyPopulation":62,"armGroups":63,"interventions":69,"overallOfficials":80,"centralContacts":85,"locations":95,"responsibleParty":116,"collaborators":120,"id":126,"slug":58,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":58,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":58,"enrollmentInfo":134,"targetDuration":58,"studyType":137,"phases":58,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":97,"whyStopped":58,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Change in the aggregate pigmentation","Percentage change in the total aggregate pigmentation including A\u002FDN and benign melanocytic nevi. Percent change will be quantified from posterior trunk digital photographic images utilizing DermViz automated image comparison software.","Pre-treatment, up to 12 months",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Change in predefined atypical nevi - size","Change in size of predefined atypical nevi at the level of the individual nevus, as documented by dermoscopy. An expert clinician panel will evaluate pre- and post-treatment dermoscopic images in a blinded manner to score the visual features of nevus atypia.",{"measure":18,"description":19,"timeFrame":12},"Change in predefined atypical nevi - margin","Change in margin of predefined atypical nevi at the level of the individual nevus, as documented by dermoscopy. An expert clinician panel will evaluate pre- and post-treatment dermoscopic images in a blinded manner to score the visual features of nevus atypia.",{"measure":21,"description":22,"timeFrame":12},"Change in predefined atypical nevi - pigmentation","Change in pigmentation of predefined atypical nevi at the level of the individual nevus, as documented by dermoscopy. An expert clinician panel will evaluate pre- and post-treatment dermoscopic images in a blinded manner to score the visual features of nevus atypia.",{"measure":24,"description":25,"timeFrame":12},"Change in histopathologic features of A\u002FDN - cellular infiltrate","Histopathologic changes within atypical nevi that are biopsied will be assessed by an expert dermatopathologist for the dendritic cell and lymphocytic cell immune infiltrate.",{"measure":27,"description":28,"timeFrame":12},"Change in histopathologic features of A\u002FDN - regression features","Histopathologic changes within atypical nevi that are biopsied will be assessed by an expert dermatopathologist for regression features including fibrosis and vascularization.",{"measure":30,"description":31,"timeFrame":12},"Change in histopathologic features of A\u002FDN - cytologic features","Histopathologic changes within atypical nevi that are biopsied will be assessed by an expert dermatopathologist for cytologic features including nuclear size and atypia.",{"measure":33,"description":34,"timeFrame":12},"Change in histopathologic features of A\u002FDN - dysplastic features","Histopathologic changes within atypical nevi that are biopsied will be assessed by an expert dermatopathologist for dysplastic features of nevi including cell architecture.",[36,39,42,45,48,51,54],{"measure":37,"description":38,"timeFrame":12},"Change in Expression of SOX-10 and BRAF","Quantify change in expression of key genes of melanomagenesis in A\u002FDN in response to anti-PD1 therapy, measured via bulk RNA-sequencing performed on biopsied nevus specimens.",{"measure":40,"description":41,"timeFrame":12},"Change in CD-8 T lymphocytes","Changes in the immune microenvironment of A\u002FDN in response to anti-PD1 therapy. Changes in T cell subsets will be quantified and compared pre- and post-treatment via multiplex IHC and multiplex IF performed on biopsied specimens.",{"measure":43,"description":44,"timeFrame":12},"Change in T-regs","Changes in the immune microenvironment of A\u002FDN in response to anti-PD1 therapy. Changes in regulatory T cells will be quantified and compared pre- and post-treatment via multiplex IHC and multiplex IF performed on biopsied specimens.",{"measure":46,"description":47,"timeFrame":12},"Change in IFN-y immune transcriptional signature","Changes in the immune microenvironment of A\u002FDN in response to anti-PD1 therapy. Changes in IFN-y immune transcriptional signature will be quantified and compared pre- and post-treatment via multiplex IHC and multiplex IF performed on biopsied specimens.",{"measure":49,"description":50,"timeFrame":12},"Change in IL-6 immune transcriptional signature","Changes in the immune microenvironment of A\u002FDN in response to anti-PD1 therapy. Changes in Immune transcriptional signature will be quantified and compared pre- and post-treatment via multiplex IHC and multiplex IF performed on biopsied specimens.",{"measure":52,"description":53,"timeFrame":12},"Change in IL-10 immune transcriptional signature","Changes in the immune microenvironment of A\u002FDN in response to anti-PD1 therapy. IL-10 immune transcriptional signature will be quantified and compared pre- and post-treatment via multiplex IHC and multiplex IF performed on biopsied specimens.",{"measure":55,"description":56,"timeFrame":12},"Change in PD1 expression","Changes in the immune microenvironment of A\u002FDN in response to anti-PD1 therapy. Changes in PD1 expression will be quantified and compared pre- and post-treatment via multiplex IHC and multiplex IF performed on biopsied specimens.",{"allocation":58,"interventionModel":58,"interventionModelDescription":58,"primaryPurpose":58,"observationalModel":59,"timePerspective":60,"maskingInfo":58},null,"COHORT","PROSPECTIVE","Given the established efficacy of anti-PD1 therapy as an adjuvant treatment in both advanced nodal and earlier stage deep primary node negative melanoma, this study hypothesizes that anti-PD1 therapy may provide a basis for effective therapeutic prevention. To study if anti-PD1 therapy can help prevent the development of melanoma, this study will examine its effects upon atypical\u002Fdysplastic nevi, which are well established as non-obligate pre-cursor lesions that are markers of increased risk of melanoma. This single agent, adjuvant study will evaluate the impact of adjuvant anti-PD1 therapy on morphology, histopathology, immunologic\u002Fmolecular features, and gene expression of atypical\u002Fdysplastic nevi present in patients with stage IIB-III melanoma. This study aims to determine if anti-PD1 therapy will increase CD8 T cell responses to melanoma antigens, resulting in immune surveillance and anti-tumor immune responses within A\u002FDN. It postulates that in response to anti-PD1 therapy, the aggregate pigmentation of total nevi including atypical\u002Fdysplastic nevi and benign melanocytic nevi will decrease with a measurable morphologic response. This study also asserts that there will be histopathologic changes within A\u002FDN including increased density of immune infiltrate and increased presence of regression features. Increased anti-tumor immune response measured by increased CD8, IFN-y, and PD-1 expression within nevi is anticipated, along with a decrease in genes involved in pathways of melanomagenesis, pigmentation, and inflammation.","Patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi who have received anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens.",[64],{"label":65,"type":58,"description":66,"interventionNames":67},"Patients Treated with single agent, adjuvant anti-PD1 therapy","Patients receiving single agent, adjuvant anti-PD1 therapy (given either as standard of care or as part of a separate investigational study)",[68],"Drug: Single agent, adjuvant anti-PD1 therapy",[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"DRUG","Single agent, adjuvant anti-PD1 therapy","One of the following Single-agent, adjuvant anti-PD1 therapies:\n\nNivolumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping cancer cells from suppressing the immune system.\n\nDose = 240 mg IV every 2 weeks\u002F480 mg every 4 weeks or, Pembrolizumab is a monoclonal antibody and a type of immune checkpoint inhibitor that's used in cancer immunotherapy. It works by attaching to the PD-1 protein on the surface of T cells, which are immune cells. This prevents cancer cells from suppressing the immune system, allowing the immune system to attack and kill the cancer cells.\n\nDose = 200 mg IV every 3 weeks\u002F 400 mg every 6 weeks",[65],[76,77,78,79],"OPDIVO®","Keytruda","Pembrolizumab","Nivolumab",[81],{"name":82,"affiliation":83,"role":84},"John M Kirkwood, MD","UPMC Hillman Cancer Center","PRINCIPAL_INVESTIGATOR",[86,91],{"name":87,"role":88,"phone":89,"phoneExt":58,"email":90},"Danielle L Bednarz, RN","CONTACT","(412) 623-1191","bednarzdl@upmc.edu",{"name":92,"role":88,"phone":93,"phoneExt":58,"email":94},"Amy Rose, RN","4126478587","kennaj@upmc.edu",[96],{"facility":83,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"RECRUITING","Pittsburgh","Pennsylvania","15232","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-79.99589,40.44062,{"lat":107,"lon":106},[110,111,112,113],{"name":87,"role":88,"phone":89,"phoneExt":58,"email":90},{"name":92,"role":88,"phone":93,"phoneExt":58,"email":94},{"name":82,"role":84,"phone":58,"phoneExt":58,"email":58},{"name":114,"role":115,"phone":58,"phoneExt":58,"email":58},"Urvashi M Joshi, MD","SUB_INVESTIGATOR",{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"SPONSOR_INVESTIGATOR","John Kirkwood","Professor of Medicine, Immunology, and Dermatology",[121,123],{"name":122,"class":6},"Melanoma Research Foundation",{"name":124,"class":125},"VeyTel Inc.","UNKNOWN","100562165",false,"NCT06599619","Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical\u002FDysplastic Nevi","A Study of the Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Features of Atypical\u002FDysplastic Nevi in Patients With Stage IIB-IIIC Melanoma","Inclusion Criteria:\n\n1. Subjects must have at least two atypical nevi of ≥ 4 mm diameter.\n2. Subjects must have a current documented history of melanoma.\n3. Subject must be ≥ 18 years and if female of childbearing potential, must agree to practice effective contraception per institutional SOC if sexually active.\n4. Subjects will have been deemed candidates for adjuvant therapy with single agent anti-PD1 therapy.\n5. Subjects must give written informed consent to participate in this study with consent signed and dated prior to entry into trial.\n\nExclusion Criteria:\n\n1. Patients with non-malignant diseases or indications that would preclude the administration of anti-PD1 therapy such as significant immune suppression or active autoimmune disease requiring disease modifying, immunosuppressive therapy, will be ineligible.\n2. Patients who have previously received anti-PD1 therapy\n3. Patients with history of other active, non-melanoma cancers\n4. Patients who are receiving other anti-neoplastic therapy.","ALL","18 Years",{"count":135,"type":136},30,"ESTIMATED","OBSERVATIONAL","This study will examine the impact of anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens upon the morphologic, histopathologic, molecular and immunologic as well as genomic features of atypical\u002Fdysplastic nevi (A\u002FDN) in patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi.",[140],"Melanoma",[142,143,144,145],"anti-PD1 therapy","immune checkpoint blockade","dysplastic nevi","BRAF and NRAS mutations","2026-01-22",{"date":148,"type":149},"2026-01-26","ACTUAL",{"date":151,"type":149},"2025-02-20",{"date":153,"type":136},"2029-05",{"name":118,"class":6},1]