[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100401882":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University of Louisville","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan.\n\nPembrolizumab: 200 mg\u002F100mL IV in three week intervals\n\nBeta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days",[13],"Dietary Supplement: Beta-Glucan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Beta-Glucan","500mg (1 capsule) by mouth twice a day for 21 days.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kelly M McMasters, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Matthew Woeste, MD","CONTACT","502-852-0325","matthew.woeste@louisville.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-85.75941,38.25424,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Kelly McMasters","Principal Investigator","100401882","beta-glucans-effect-on-pembrolizumab-immunologic-response-in-stage-iii-iv-melanoma-100401882",false,"NCT04513028","Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma","Inclusion Criteria:\n\n* Any patients with suspected (clinical) or definitive (tissue) diagnosis of Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active evidence of disease (NED).\n* Must be treatment naïve or have had treatment no less than 6 months prior to enrollment\n* 18 years or older\n* Must be able to take pills\n* ECOG performance status of 0-3\n* Ability to understand and willingness to sign a written informed consent\n* Members of all racial and ethnic groups are eligible for this study\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions attributed to beta-glucan\n* Patients receiving continuous or other ongoing immunosuppressive therapy\n* Uncontrolled intercurrent illness including, but not limited to, autoimmune diseases, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Any patients who have serious autoimmune toxicity during the study period, or those who have disease recurrence during the 6-week study period should be excluded and analyzed separately\n* Patients with mucosal melanoma\n* Patients with concurrent malignancy or recent history thereof","ALL","18 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"NA","The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.",[67,68],"Melanoma Stage III","Melanoma Stage IV","2025-10-28",{"date":71,"type":72},"2025-10-30","ACTUAL",{"date":74,"type":72},"2020-11-03",{"date":76,"type":61},"2027-01-15",{"name":49,"class":6},1]