[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624030":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":63,"collaborators":23,"id":67,"slug":23,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":23,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":23,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":23,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Iowa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"5-Azacitidine Plus PD-1\u002FPD-L1 inhibitor","EXPERIMENTAL","This Phase I study will assess 6 doses of 5-Azacitidine (5, 10, 15, 25, 50 and 75 mg\u002Fm2) in combination with a PD1\u002FPD-L1 inhibitor. The PD1\u002FPD-L1 inhibitor will be given at standard of care dosing approved by the FDA for this indication. Inhibitors approved for study indications include Pembrolizumab, Nivolumab, and Cemiplimab.",[13,14,15,16],"Drug: 5 Azacytidine","Drug: Pembrolizumab","Drug: Nivolumab","Drug: Cemiplimab",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","5 Azacytidine","5-Azacitidine (Azacitidine) is a nucleoside analogue chemotherapy drug",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Pembrolizumab","Pembrolizumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Nivolumab","Nivolumab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Cemiplimab","Cemiplimab is a high-affinity humanized monoclonal antibody that functions as immune checkpoint inhibitor",[9],[37],{"name":38,"affiliation":5,"role":39},"Mohammed Milhem, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},"CONTACT","+1 319 356 2324","mohammed-milhem@uiowa.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Iowa Health Care","RECRUITING","Iowa City","Iowa","52242","United States",{"type":54,"coordinates":55},"Point",[56,57],-91.53017,41.66113,{"lat":57,"lon":56},[60,61],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},{"name":62,"role":42,"phone":23,"phoneExt":23,"email":23},"Milhem",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Mohammed Milhem","Clinical Professor","100624030",false,"NCT07404332","5-Azacitidine Plus PD-1\u002FPD-L1 Inhibitor With PD-1\u002FPD-L1 Refractory Tumors","Phase I Study of 5-Azacitidine Plus PD-1\u002FPD-L1 Inhibitor in Patients With PD-1\u002FPD-L1 Refractory Tumors","Inclusion Criteria:\n\n* Written and voluntary informed consent.\n* At least 18 years of age or older.\n* Histologically and radiologically confirmed locally advanced or metastatic unresectable solid tumor malignancy for which PD-1 or PD-L1 therapy is already approved by the FDA. Locally advanced is defined as unresectable in the opinion of the treating physician. A repeat biopsy is required if previous biopsy tissue is unavailable.\n* At least one Response Evaluation Criteria in Solid Tumors (RECIST 1.1) - defined target lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry on all pre-disease performance without restriction), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work), or 2 (ambulatory and capable of self-care but unable to carry out any work activities, spending more than 50% of waking hours up and about).\n* Documented progression on PD1 or PD-L1 inhibitors.\n* Recovery from any acute toxicity associated with prior therapy to grade 1.\n* Renal function (creatinine level within normal institutional limit, or creatinine clearance \\>15 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).\n* Liver function (AST\u002FALT \\\u003C3.0 X institutional upper limit of normal OR \\\u003C5 X institutional upper limit of normal in cases of liver metastasis; total bilirubin ≤ 1.5 times upper limit of normal).\n* Adequate hematological lab values including:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1.0 X 109\u002FL\n  * Platelets ≥ 100X109\u002FL\n  * Hemoglobin ≥ 7.0 g\u002FdL\n* Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from time of screening, throughout the whole duration of the drug treatment, and during the 6-month post-treatment washout period.\n* Patients may have previously received a hypomethylating agent, as long as it was not given in combination with ipilimumab.\n* Patients may have previously received ipilimumab but must have relapsed or progressed while on therapy.\n* Patients must have adequate archival tissue available for the purpose of downstream methylation status assessment, immunohistochemistry, RNA expression (10 slides at 5µM). If archival tissue is not available, a repeat biopsy is required.\n\nExclusion Criteria:\n\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Patients with active, untreated metastases in the central nervous system.\n* Patients who are pregnant or breastfeeding.\n* Patients who have an active infection.\n* Patients with significant hematologic, hepatic, and renal function impairment.\n* Patients who are being treated for any concurrent medical condition requiring the use of systemic steroids or history of long-term use of systemic steroids.\n* Patients who have a history of inflammatory bowel disease or a history of symptomatic autoimmune disease.\n* Patients who have had any major surgical procedure or significant traumatic injury within 28 days prior to study enrollment.\n* Patients who have received chemotherapy, immunosuppressive agents or any investigational drug within 28 days prior to starting the study drugs.\n* Patients who have any underlying medical condition which, in the treating physician's opinion, will make the administration of study drugs hazardous or obscure the interpretation of adverse events.","ALL","18 Years","99 Years",{"count":77,"type":78},35,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","This is a Phase I study to determine the optimal biological dose (OBD) of 5-Azacitidine in combination with PD-1\u002FPD-L1 inhibitors in patients with tumors refractory to PD-1\u002FPD-L1 inhibitors, for which such treatments have been approved.",[84,85,86],"Solid Tumor","Locally Advanced Solid Tumor","Metastatic Tumor","2026-05-22",{"date":89,"type":90},"2026-05-28","ACTUAL",{"date":92,"type":90},"2026-02-11",{"date":94,"type":78},"2031-02-28",{"name":65,"class":6},1]