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Hospital","Atlanta","Georgia","30342",{"type":43,"coordinates":74},[75,76],-84.38798,33.749,{"lat":76,"lon":75},{"facility":79,"status":28,"city":80,"state":81,"zip":82,"country":40,"countryCode":41,"cosmosGeoPoint":83,"geoPoint":87,"contacts":28},"University of Cincinnati Cancer Institute","Cincinnati","Ohio","45267",{"type":43,"coordinates":84},[85,86],-84.51439,39.12711,{"lat":86,"lon":85},{"facility":89,"status":28,"city":90,"state":91,"zip":92,"country":40,"countryCode":41,"cosmosGeoPoint":93,"geoPoint":97,"contacts":28},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107",{"type":43,"coordinates":94},[95,96],-75.16362,39.95238,{"lat":96,"lon":95},{"facility":99,"status":28,"city":100,"state":101,"zip":102,"country":40,"countryCode":41,"cosmosGeoPoint":103,"geoPoint":107,"contacts":28},"Providence Regional Medical Center","Everett","Washington","98201",{"type":43,"coordinates":104},[105,106],-122.20208,47.97898,{"lat":106,"lon":105},{"type":109,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[111],{"name":32,"class":6},"100261147","phase-1-multi-center-phase-iiia-trial-of-an-autologous-tumor-lysate-tl--yeast-cell-wall-particles-ycwp--dendritic-cells-dc-vaccine-in-addition-to-standard-of-care-checkpoint-inhibitor-of-choice-in-metastatic-melanoma-patients-with-measurable-disease-100261147",true,"NCT02678741","Multi-center Phase I\u002FIIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.","Inclusion Criteria:\n\n* 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix A)\n* Metastatic melanoma eligible for {or currently on} standard of care CPI therapy (treating physician's choice) with measurable disease.\n* Approximately 1 cm3 preferred but 1 mg minimum of accessible and dispensable tumor (minimum of 3 passes with a core needle)\n* Able to tolerate CPI treatment regimen {if already started}\n* Adequate organ function as determined by the following laboratory values:\n* ANC ≥ 1,000\u002FμL\n* Platelets ≥ 75,000\u002FμL\n* Hgb ≥ 9 g\u002FdL\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50% of lower limit of normal (LLN)\n* Total bilirubin ≤ 1.5 ULN\n* ALT and AST ≤ 1.5 ULN\n* For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)\n\nExclusion Criteria:\n\n* Inability to tolerate CPI therapy {if already started}\n* Rapidly progressing multi-focal metastatic melanoma\n* Insufficient tumor available to produce vaccine\n* ECOG \\>2 performance status (Appendix A)\n* Immune deficiency disease or known history of HIV, HBV, HCV\n* Receiving immunosuppressive therapy including chronic steroids (except physiologic maintenance doses), methotrexate, or other known immunosuppressive agents\n* Pregnancy (assessed by urine HCG)\n* Breast feeding\n* Active pulmonary disease requiring medication to include multiple inhalers (\\>2 inhalers and one containing steroids)\n* Involved in other experimental protocols (except with permission of the other study PI)",false,"ALL","18 Years",{"count":122,"type":123},26,"ACTUAL","INTERVENTIONAL",[126,127],"PHASE1","PHASE2","Assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.",[130],"Metastatic Melanoma","COMPLETED","2024-03-08",{"date":134,"type":123},"2024-03-12",{"date":136,"type":28},"2016-02",{"date":138,"type":123},"2019-11-13",{"name":5,"class":6},7]