[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577651":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":119,"collaborators":30,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":30,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":30,"enrollmentInfo":130,"targetDuration":30,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)","EXPERIMENTAL","Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for irEC",[13],"Biological: SER-155",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","SER-155","SER-155 (Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated) is an experimental designed ecology of 16 unique, human-commensal bacterial strains encapsulated for oral administration and will be provided by Seres as an investigational drug",[9],[21],"Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated",[23],{"name":24,"affiliation":5,"role":25},"David Faleck, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","212-639-8286",null,"faleckd@mskcc.org",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Michael Postow, 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Centre","11553",{"type":46,"coordinates":113},[114,115],-73.64124,40.65871,{"lat":115,"lon":114},[118],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":30},{"type":120,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100577651","phase-1-a-study-of-ser-155-to-treat-diarrhea-in-people-on-immunotherapy-100577651",false,"NCT06801067","A Study of SER-155 to Treat Diarrhea in People on Immunotherapy","A Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis","Inclusion Criteria:\n\n* Age \\> 18 years\n* Receipt of ICI (single-agent or combination) within the 180 days preceding screening.\n\nConcurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.\n\n* Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.\n\nabdominal pain, bloody or mucoid stools)\n\n* Able to swallow oral medication\n* Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \\\u003C1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.\n* Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.\n\nExclusion Criteria:\n\n* Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.\n* Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and\u002For infliximab, vedolizumab or ustekinumab\n* Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs\n* Admitted to the hospital for irEC\n* Prednisone (or steroid equivalent) dose \\> 10 mg a day for a non-GI irAE at time of screening\n* Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis\n* Pregnant or lactating women\n* Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics\n* Severe neutropenia, as defined by an absolute neutrophil count (ANC) \\\u003C 500 cells\u002Fmm\\^3, at time of screening\n* Treatment with investigational medications used for diarrhea\u002Fcolitis treatment and microbiome therapeutics within 30 days prior to enrollment\n* Known allergy or intolerance to oral vancomycin\n* Unable to comply with the protocol requirements\n* Any condition that in the opinion of the investigator may increase the risk of study participation and\u002For may interfere with the interpretation of study results","ALL","18 Years",{"count":131,"type":132},15,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.",[138,139],"Diarrhea","Enterocolitis",[138,17,139,5,141],"24-231","2025-12-01",{"date":144,"type":145},"2025-12-02","ACTUAL",{"date":147,"type":145},"2025-01-24",{"date":149,"type":132},"2027-01-24",{"name":5,"class":6},7]