[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629257":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":74,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Merkel cell carcinoma","EXPERIMENTAL","Participants with unresectable Merkel cell carcinoma who progressed on prior PD-1 or PD-L1 inhibitor",[13],"Drug: ASTX727 + retifanlimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ASTX727 + retifanlimab","Participants take oral ASTX727 and receive retifanlimab through a vein",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Vincent Ma, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Cancer Connect","CONTACT","800-622-8922","clinicaltrials@cancer.wisc.edu",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Renae Quale, RN","rmq@medicine.wisc.edu",[35],{"facility":36,"status":20,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of Wisconsin-Carbone Cancer Center","Madison","Wisconsin","53792","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-89.40123,43.07305,{"lat":46,"lon":45},[49,50],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100629257","phase-1-astx727--retifanlimab-dlwr-for-advanced-merkel-cell-after-progression-on-anti-pd-l1-100629257",false,"NCT07472322","ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1","UW26001 Phase I\u002FII Study on the Safety, Tolerability, and Preliminary Efficacy of ASTX727 (Decitabine\u002FCedazuridine) and Retifanlimab-dlwr in Patients With Advanced Merkel Cell Carcinoma Who Have Progressed on Anti-PD-(L)1 Inhibitor","Inclusion Criteria:\n\n* Individuals age ≥ 18 years at the time of consent\n* ECOG Performance Status of 0-2\n* Histological or cytological evidence\u002Fconfirmation of Merkel cell carcinoma (MCC)\n* Must have unresectable stage III\u002FIV MCC per American Joint Committee on Cancer (AJCC) 8th edition. Participants must be considered unresectable based on the judgment of the treating physician\n* Participants must have progressed on prior programmed cell death protein-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor-based therapy. Participants must have received at least 2 doses of anti-PD-1 or anti-PD-L1 inhibitor. Relapsed\u002Frefractory disease from prior adjuvant PD-1 or PD-L1 inhibitor is permitted. Prior treatment with retifanlimab is permitted.\n* Demonstrate adequate organ and marrow function; all screening labs to be obtained within 28 days prior to registration\n\nExclusion Criteria:\n\n* Prior treatment with a hypomethylating agent (HMA) (e.g., azacitidine, decitabine, guadecitabine)\n* History of clinically significant intolerance, hypersensitivity, or treatment discontinuation of an anti-PD-1 or anti-PD-L1 inhibitor due to grade 3 or greater immune-related adverse events (irAEs). Participants who are able to be successfully rechallenged with anti-PD-(L)1 inhibitor without recurrence of grade 3 or greater irAEs are permitted on study. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study drug(s) may be included (e.g. hearing loss, hypothyroidism, adrenal insufficiency, type 1 diabetes, or other endocrinopathies) after consultation with the sponsor investigator\n* Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is \\> 30 Gy within 6 months before the first dose of study treatment\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration\n* Active infection requiring systemic therapy within 7 days prior to registration","ALL","18 Years",{"count":63,"type":64},31,"ESTIMATED","INTERVENTIONAL",[67,68],"PHASE1","PHASE2","The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are:\n\n* Can the combination shrink cancer and lower the chance of the cancer growing or spreading?\n* Is the combination better than standard of care for Merkel cell cancer?\n\nParticipants will:\n\n* Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years.\n* Visit the clinic once every 2 weeks for checkups and tests",[71,72,73],"Merkel Cell Carcinoma","Merkel Cell Carcinoma, Stage III","Merkel Cell Carcinoma, Stage IV","NOT_YET_RECRUITING","2026-06-29",{"date":77,"type":78},"2026-07-01","ACTUAL",{"date":80,"type":64},"2026-07",{"date":82,"type":64},"2031-05",{"name":5,"class":6},1]