[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06848088":3,"trial-entities:NCT06848088":168,"trial-summary:NCT06848088":171},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":45,"sex":64,"minimum_age":65,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":161,"overall_officials":162,"references":166,"see_also_links":167},"NCT06848088","R3767-ONC-2466","A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment","Extended Follow-up of Patients With Melanoma Treated With Fianlimab Plus Cemiplimab in Expansion Cohorts From Study R3767-ONC-1613","ENROLLING_BY_INVITATION","2029-10-10","2026-07","2026-07-13","2025-04-14","Regeneron Pharmaceuticals","INDUSTRY",false,"This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).\n\nThe aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).",null,[19],"Melanoma",[21],"Advanced Skin Cancer","INTERVENTIONAL","OTHER",[25],"PHASE2",{"count":27,"type":28},48,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"DRUG","Fianlimab+cemiplimab","No study drug administered in this observational study.",[35,36],"No Progressive Disease at Enrollment","With Disease Progression at Enrollment",[38,39,40],"REGN3767","REGN2810","Libtayo®",[42],{"measure":43,"timeFrame":44},"Death from any cause starting at time of initial treatment with fianlimab and cemiplimab in study R3767-ONC-1613","Up to 4 years",[46,48,50,52,54,56,58,60,62],{"measure":47,"timeFrame":44},"Progressive-Free Survival (PFS)",{"measure":49,"timeFrame":44},"Objective Response Rate (ORR)",{"measure":51,"timeFrame":44},"Duration of Response (DOR)",{"measure":53,"timeFrame":44},"Disease Control Rate (DCR)",{"measure":55,"timeFrame":44},"Incidence of Serious Adverse Events (SAEs)",{"measure":57,"timeFrame":44},"Severity of SAEs",{"measure":59,"timeFrame":44},"Incidence of treatment-related AEs",{"measure":61,"timeFrame":44},"Severity of treatment-related AEs",{"measure":63,"timeFrame":44},"Incidence of anti-cancer therapies received since end of treatment with fianlimab and cemiplimab in study R3767-ONC-1613","ALL","18 Years",{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Key Inclusion Criteria:\n\n1\\. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)\n\nKey Exclusion Criteria:\n\nNone\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria may apply",[71,72],"ADULT","OLDER_ADULT",[74,83,90,98,106,114,121,129,137,145,153],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"The Angeles Clinic and Research Institute - West Los Angeles Office","Los Angeles","California","90025","United States",{"lat":81,"lon":82},34.05223,-118.24368,{"facility":84,"city":85,"state":77,"zip":86,"country":79,"geoPoint":87},"California Pacific Medical Center","San Francisco","94115",{"lat":88,"lon":89},37.77493,-122.41942,{"facility":91,"city":92,"state":93,"zip":94,"country":79,"geoPoint":95},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045",{"lat":96,"lon":97},39.72943,-104.83192,{"facility":99,"city":100,"state":101,"zip":102,"country":79,"geoPoint":103},"University of Kansas Hospital","Westwood","Kansas","66205",{"lat":104,"lon":105},39.04056,-94.6169,{"facility":107,"city":108,"state":109,"zip":110,"country":79,"geoPoint":111},"Henry Ford Hospital","Detroit","Michigan","48202",{"lat":112,"lon":113},42.33143,-83.04575,{"facility":115,"city":116,"state":109,"zip":117,"country":79,"geoPoint":118},"Cancer & Hematology Centers of Western Michigan","Grand Rapids","49546",{"lat":119,"lon":120},42.96336,-85.66809,{"facility":122,"city":123,"state":124,"zip":125,"country":79,"geoPoint":126},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08901",{"lat":127,"lon":128},40.48622,-74.45182,{"facility":130,"city":131,"state":132,"zip":133,"country":79,"geoPoint":134},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"lat":135,"lon":136},36.16589,-86.78444,{"facility":138,"city":139,"state":140,"zip":141,"country":79,"geoPoint":142},"South Texas Oncology And Hematology","San Antonio","Texas","78229",{"lat":143,"lon":144},29.42412,-98.49363,{"facility":146,"city":147,"state":148,"zip":149,"country":79,"geoPoint":150},"Virginia Cancer Care Specialist, PC","Fairfax","Virginia","22031",{"lat":151,"lon":152},38.84622,-77.30637,{"facility":154,"city":155,"zip":156,"country":157,"geoPoint":158},"St. Vincent's University Hospital","Dublin","D04 T6F4","Ireland",{"lat":159,"lon":160},53.33306,-6.24889,[],[163],{"name":164,"affiliation":13,"role":165},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":169,"biomarkers":170},[19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]