[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575381":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":56,"collaborators":21,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":21,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":21,"enrollmentInfo":67,"targetDuration":21,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":41,"whyStopped":21,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pembrolizumab + Cyclophosphamide","EXPERIMENTAL","Pembrolizumab 200mg IV every 21 days or 400 mg IV every 42 days Cyclophosphamide 50mg PO daily on days 1-14 every 21 days for melanoma patients",[13,14],"Drug: Pembrolizumab","Drug: Cyclophosphamide",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Pembrolizumab","Given IV",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Cyclophosphamide","Given PO",[9],[27],{"name":28,"affiliation":29,"role":30},"Warren Chow, MD","Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Chao Family Comprehensive Cancer Center University of California, Irvine","CONTACT","1-877-827-8839","ucstudy@uci.edu",{"name":38,"role":34,"phone":21,"phoneExt":21,"email":21},"University of California Irvine Medical",[40],{"facility":33,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Orange","California","92868","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-117.85311,33.78779,{"lat":51,"lon":50},[54],{"name":28,"role":34,"phone":55,"phoneExt":21,"email":36},"877-827-8839",{"type":30,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Warren Chow","HS Clinical Professor and Associate Director for Clinical Science","100575381","phase-2-metronomic-cyclophosphamide-with-pembrolizumab-in-checkpoint-inhibitor-refractory-melanoma-100575381",false,"NCT06771544","Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent form (ICF)\n* Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy\n* Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator\u002F radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit.\n* Life expectancy of at least 12 weeks\n* Adequate bone marrow, liver, and renal function\n* Hemoglobin ≥9.0 g\u002FdL\n* Platelets ≥100\u002Fmm3\n* ANC ≥1.5\u002Fmm3\n* Creatinine Clearance ≥ 30mL\u002Fmin Cockcroft-Gault CrCl, mL\u002Fmin = (140 - age) × (weight, kg) × (0.85 if female) \u002F (72 × Cr, mg\u002FdL).\n* AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin \\\u003C 3.1 mg\u002FdL.\n* Has progressed on a prior PD-1\u002FPD-L1 treatment\n* Recovered from toxicities of pembrolizumab to Grade ≤1, excluding endocrine toxicities\n* Prior Receipt of PD-1\u002FPD-L1 therapy within 9 weeks prior to the first dose of the investigational therapy.\n* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment\n* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of study intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n* Pregnant or lactating women are prohibited from enrolling in this study.\n* Male participants are not allowed to donate sperm from the time of enrollment until 6 months after administration of study interventions.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of ocular or metastatic uveal melanoma\n* Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:\n* Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the Principal Investigator.\n* Completely resected basal cell and squamous cell skin cancers.\n* Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.\n* Completely resected carcinoma in situ of any type\n* Participants ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)-1 regimen that led to discontinuation of that prior therapy and would thus prevent retreatment or with an immune-related adverse event (irAE) of grade 3 or greater\n* Participants with known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. NOTE: Participants with previously treated brain metastases may participate provided ALL of the following apply:\n* Treated CNS lesions are radiographically stable (without evidence of progression for ≥ 28 days prior to the first dose of study intervention) after intervention (eg, surgery and\u002For radiation).\n* Neurologically stable and on stable dose of ≤ 10mg of prednisone equivalent steroids for at least 7 days prior to the first dose of study intervention.\n* Any prior investigational or standard cancer therapy, with exception of PD-1\u002FPD-L1 (includes nivolumab + Relatlimab) therapy, chemotherapy or radiation within 6-9 weeks of the first dose of the investigational therapy (see Inclusion Criteria)\n* Presence of B-RAF driver mutation without prior receipt of BRAF +\u002F- MEK inhibitors, unless patient declines BRAF +\u002F-MEK inhibition for any reason or is unable to tolerate BRAF and\u002For MEK inhibitors.\n* Participants with a known history of chronic viral infections as indicated below. If patients do not have a known history, testing is not required during the screening period to confirm the patient has an active infection.\n* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \\> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.\n* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.\n* Active HIV infection. Those with HIV infections on combination antiretroviral medications with stable CD4 count \\>200\u002Fmicroliters as measured within screening time period. If the patient does not have a known history of HIV, then testing is not required during screening to confirm presence or absence of HIV.\n* Positive serum pregnancy test\n* Participants with out-of-range screening laboratory values as defined below. NOTE: Hematology evaluations must be performed \\>7 days from any blood transfusion. Or blood product transfusion or from any dose of hematologic growth factor.\n* Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) \\\u003C 30 mL\u002Fmin\n* Total bilirubin \\> 1.5 × ULN; participants with Gilbert's syndrome are excluded if total bilirubin \\> 3.0 × ULN; or direct bilirubin \\> 1.5 × ULN\n* Albumin \\\u003C 3.0 g\u002FdL\n* Absolute lymphocyte count \\\u003C 0.5 × 10\\^9\u002FL\n* Participants with a history of allogeneic tissue\u002Fsolid organ transplant","ALL","18 Years",{"count":68,"type":69},14,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.",[75,76,77,78],"Melanoma","Melanoma Stage III","Melanoma (Skin)","Melanoma Stage IV",[75,80,81,82,18,23],"Melanoma, Stage III","Skin","Melanoma, Stage IV","2026-03-06",{"date":85,"type":86},"2026-03-10","ACTUAL",{"date":88,"type":86},"2024-12-23",{"date":90,"type":69},"2028-12",{"name":5,"class":6},1]