[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621891":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":28,"responsibleParty":92,"collaborators":10,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":10,"enrollmentInfo":103,"targetDuration":10,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":113,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Centre Georges Francois Leclerc","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Advanced NSCLC or Melanoma - Anti-PD-(L)1 Therapy",null,"This cohort includes patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or inoperable melanoma who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy, either as monotherapy or in combination with other approved therapies.\n\nParticipants will follow standard clinical management, and study-specific procedures include four blood draws for extracellular vesicle (EV) analysis at baseline and during follow-up, collection of standard immunohistochemistry results (PD-1, PD-L1, CTLA-4, Tim-3, LAG-3, TIGIT), thoraco-abdominopelvic CT imaging, and tumor DNA genotyping performed as part of routine care.",[13],{"name":14,"affiliation":15,"role":16},"Jessica JG GOBBO, Clinical Research Scientist","Centre Georges François Leclerc","STUDY_CHAIR",[18,24],{"name":19,"role":20,"phone":21,"phoneExt":22,"email":23},"Courèche CK KADERBHAI, Doctor","CONTACT","03 80 73 75 28","+33","cgkaderbhai@cgfl.fr",{"name":25,"role":20,"phone":26,"phoneExt":22,"email":27},"Anne-Laure ALR REROLE, Project manager","03 45 34 88 46","arerole@cgfl.fr",[29,46,56,68,78],{"facility":30,"status":10,"city":31,"state":10,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"CHU Besançon - Service Dermatologie","Besançon","25000","France","FR",{"type":36,"coordinates":37},"Point",[38,39],6.01815,47.24878,{"lat":39,"lon":38},[42],{"name":43,"role":20,"phone":44,"phoneExt":10,"email":45},"Charlée CN NARDIN, Doctor","03 70 63 20 05","cnardin@chu-besancon.fr",{"facility":47,"status":10,"city":31,"state":10,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"CHU Besançon - Service Pneumologie Oncologie Thoracique",{"type":36,"coordinates":49},[38,39],{"lat":39,"lon":38},[52],{"name":53,"role":20,"phone":54,"phoneExt":10,"email":55},"Guillaume GE EBERST, Doctor","03 70 63 22 06","geberst@chu-besancon.fr",{"facility":57,"status":10,"city":58,"state":10,"zip":59,"country":33,"countryCode":34,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Centre Georges-François Leclerc","Dijon","21000",{"type":36,"coordinates":61},[62,63],5.01391,47.31344,{"lat":63,"lon":62},[66],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":67},"CGKaderbhai@cgfl.fr",{"facility":69,"status":10,"city":58,"state":10,"zip":59,"country":33,"countryCode":34,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"CHU Dijon - Service Oncologie Médicale",{"type":36,"coordinates":71},[62,63],{"lat":63,"lon":62},[74],{"name":75,"role":20,"phone":76,"phoneExt":10,"email":77},"Ayoube AZ ZOUAK, Doctor","03 80 29 58 64","ayoube.zouak@chu-dijon.fr",{"facility":79,"status":10,"city":80,"state":10,"zip":81,"country":33,"countryCode":34,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Centre Leon Berard - Service Oncologie Médicale","Lyon","69000",{"type":36,"coordinates":83},[84,85],4.84789,45.74906,{"lat":85,"lon":84},[88],{"name":89,"role":20,"phone":90,"phoneExt":10,"email":91},"Mona MA AMINI-ADLE, Doctor","04 78 78 59 96","mona.amini-adle@lyon.unicancer.fr",{"type":93,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100621891","predicting-response-to-anti-pd-1pd-l1-immunotherapy-by-plasma-extracellular-vesicle-analysis-100621891",false,"NCT07376512","Predicting Response to Anti-PD-1\u002FPD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis","EVpredict","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) or locally advanced\u002Fmetastatic unresectable melanoma.\n* Patient scheduled to initiate anti-PD-(L)1 therapy, either as monotherapy or in combination (other immune checkpoint inhibitors, chemotherapy, etc.).\n* Baseline tumor assessment performed within 28 days prior to enrollment (CT scan of thorax, abdomen, and pelvis) with at least one measurable lesion according to RECIST 1.1 criteria.\n* Life expectancy \\>6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at enrollment.\n* Patient able to provide informed consent and comply with study procedures.\n* Patient covered by a social security system or equivalent.\n\nExclusion Criteria:\n\n* Prior treatment with immunotherapy.\n* Presence of EGFR or ALK mutation (applicable only to the lung cohort).\n* Presence of another synchronous malignancy.\n* Diagnosis of uveal melanoma.\n* Treatment with systemic immunosuppressants, including within 28 days prior to enrollment, or corticosteroids \\>10 mg\u002Fday, including within 14 days prior to enrollment.\n* Disease not measurable according to RECIST 1.1 criteria.\n* Positive serology for HIV, HBV, or HCV.\n* Pregnant or breastfeeding women.\n* Inability to comply with study follow-up and visits for geographic, social, or psychological reasons.\n* Individuals deprived of liberty or under legal guardianship (including curatorship).","ALL","18 Years",{"count":104,"type":105},378,"ESTIMATED","OBSERVATIONAL","The objective of this prospective multicenter study is to evaluate whether the analysis of immunological biomarkers present in circulating extracellular vesicles is associated with the response to anti-PD-1\u002FPD-L1 treatments in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or unresectable melanoma.\n\nPatients will receive standard-of-care treatment and will be followed according to routine clinical practice. The study involves the collection of four study-specific blood samples at different time points during follow-up, as well as the collection of standard immunohistochemistry results, thoraco-abdomino-pelvic CT scans, and tumor DNA genotyping analyses performed as part of routine care.\n\nThe study aims to determine:\n\n* whether baseline biomarkers in extracellular vesicles are associated with response to anti-PD-1\u002FPD-L1 treatment,\n* how these biomarkers change over the course of treatment, and\n* to provide exploratory data for the development of predictive immunological response signatures.",[109,110],"Non-Small Cell Lung Cancer","Melanoma (Skin Cancer)",[112],"standard treatment with anti-PD-(L)1 monotherapy or combination therapy","NOT_YET_RECRUITING","2026-01-22",{"date":116,"type":117},"2026-01-29","ACTUAL",{"date":119,"type":105},"2026-03-01",{"date":121,"type":105},"2030-03-01",{"name":5,"class":6},5]