[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mohammed Milhem\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100624030","phase-1-5-azacitidine-plus-pd-1pd-l1-inhibitor-with-pd-1pd-l1-refractory-tumors-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":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Solid Tumor","Locally Advanced Solid Tumor","Metastatic Tumor","RECRUITING","2026-05-22",{"date":33,"type":34},"2026-05-28","ACTUAL",{"date":36,"type":34},"2026-02-11",{"date":38,"type":21},"2031-02-28",{"name":40,"class":41},"Mohammed Milhem","OTHER",""]