[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652351":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":78,"centralContacts":83,"locations":93,"responsibleParty":109,"collaborators":87,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":87,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":87,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":87,"overallStatus":134,"whyStopped":87,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"CPS>1, physician's choice for Cohort A or Cohort B","EXPERIMENTAL","Cohort A:\n\nCohort A1\\_Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + 4.5g daily oral arginine Cohort A2\\_Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + q3w 30g IV arginine Cohort A3\\_Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine A3 Expansion\\_Continue previous regimen\n\nOR\n\nCohort B:\n\nCohort B1\\_q3w IV bevacizumab, q3w IV pembrolizumab, daily oral phosphamide, 4.5g daily oral arginine Cohort B2\\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine Cohort B3\\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine B3 Expansion\\_ Continue previous regimen",[13,14,15,16,17,18,19,20],"Drug: Cohort A1","Drug: Cohort A2","Drug: Cohort A3","Drug: A3 Expansion","Drug: Cohort B1","Drug: Cohort B2","Drug: Cohort B3","Drug: B3 Expansion",{"label":22,"type":10,"description":23,"interventionNames":24},"CPS\u003C1, must be assigned to Cohort B","Cohort B:\n\nCohort B1\\_q3w IV bevacizumab, q3w IV pembrolizumab, daily oral phosphamide, 4.5g daily oral arginine Cohort B2\\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine Cohort B3\\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine B3 Expansion\\_ Continue previous regimen",[17,18,19,20],[26,36,43,49,54,62,68,73],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Cohort A1","Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + 4.5g daily oral arginine",[9],[32,33,34,35],"Oral Arginine (Arginaid®)","Pembrolizumab","bevacizumab","Paclitaxel",{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Cohort A2","Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + q3w 30g IV arginine",[9],[41,33,34,42],"IV Arginine (R-Gene® 10)","paclitaxel",{"type":27,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Cohort A3","Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine",[9],[48,32,33,34,42],"IV arginine",{"type":27,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"A3 Expansion","Continue - Weekly paclitaxel + q3w pembrolizumab +\u002F- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine",[9],[48,32,33,34,42],{"type":27,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Cohort B1","q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 4.5g daily oral arginine",[22,9],[32,59,60,61],"IV bevacizumab","IV Pembrolizumab","oral phosphamide",{"type":27,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Cohort B2","q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine",[22,9],[48,59,67,61],"IV pembrolizumab",{"type":27,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Cohort B3","q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine",[22,9],[48,32,61,67,59],{"type":27,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"B3 Expansion","Continue - q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine + 4.5g PO arginine",[22,9],[48,32,61,67,59],[79],{"name":80,"affiliation":81,"role":82},"Rebecca C Arend, MD","The University of Alabama at Birmingham","PRINCIPAL_INVESTIGATOR",[84,89],{"name":80,"role":85,"phone":86,"phoneExt":87,"email":88},"CONTACT","(205) 934-4986",null,"rarend@uabmc.edu",{"name":90,"role":85,"phone":91,"phoneExt":87,"email":92},"Rebecca A Arend","2059752257","al2eli@uab.edu",[94],{"facility":95,"status":87,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"University of Alabama at Birmingham Womens & Infants Center","Birmingham","Alabama","35233","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-86.80249,33.52066,{"lat":105,"lon":104},[108],{"name":80,"role":85,"phone":87,"phoneExt":87,"email":88},{"type":110,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":87,"oldOrganization":87},"SPONSOR_INVESTIGATOR","Rebecca Arend","Associate Professor","100652351","phase-1-study-of-supplemental-arginine-with-chemotherapy-and-immunotherapy-in-platinum-resistant-ovarian-fallopian-tube-and-peritoneal-cancer-100652351",false,"NCT07772882","Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer","Phase I Study of Supplemental Arginine With Chemotherapy and Immunotherapy in Platinum Resistant Ovarian, Fallopian Tube, and Peritoneal Cancer","Inclusion Criteria:\n\n1. Must be at least 18 years of age\n2. ECOG performance status of 0 or 1 (see Appendix A).\n3. Patient must be a candidate for either cohort A or cohort B treatment backbone.\n\n   * For patients enrolling on treatment cohort A, PD-L1 positivity must be ≥1. Patient's with PD-L1 positivity ≥1% can enroll in cohort B at physician's discretion.\n   * If PD-L1 positivity is unavailable or is \\\u003C1%, patients can only enroll on treatment cohort B.\n4. Patients must have high-grade serous or endometrioid histology\n5. Recovery to baseline or ≤ Grade 1 CTCAE v.5.0 from toxicities related to the prior therapy, unless after discussion with the medical monitor the AE(s) are deemed clinically non-significant and\u002For stable on supportive therapy\n6. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n7. Patients must have adequate hematologic, liver and kidney functions prior to lead-in chemotherapy defined as:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 109 \u002FL (1,500\u002FμL)\n   2. Platelet count ≥ 100 x 109 \u002FL (100,000\u002FμL) without platelet transfusion in the prior 10 days\n   3. Hemoglobin ≥ 9.0 g\u002FdL\n   4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n   6. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \\\u003C 3.0 x ULN)\n   7. Serum albumin ≥ 2 g\u002FdL.\n\nExclusion Criteria:\n\n1. History of allergic reactions contributed to compounds of similar chemical or biological composition to R-Gene 10 or Arginaid.\n2. Patient unwilling\u002Funable to receive daily arginine treatment (IV or oral)\n3. Patients with a history of serologically confirmed HSV-1 or HSV-2 outbreaks\n4. Receiving systemic corticosteroids or have severe comorbities where treatment with corticosteroids may be required.\n5. Actively treated auto-immune disease.\n6. Taking medications that interfere with the urea cycle such as valproate or xanthine oxidase inhibitors.\n7. Current intercurrent illnesses including active infection, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.\n8. Patients with history of Peptic Ulcer Disease\n9. Contraindications to receive standard of care treatment backbone with either paclitaxel, bevacizumab, pembrolizumab, or cyclophosphamide.","FEMALE","18 Years","89 Years",{"count":124,"type":125},24,"ESTIMATED","INTERVENTIONAL",[128],"PHASE1","This is an open-label, Phase 1 clinical study to evaluate the safety, tolerability, PK profiles, and clinical activity of IV and PO arginine supplementation + SOC chemoimmunotherapy regimens in participants with PROC.",[131,132,133],"Platinum Resistant Ovarian Cancer","Fallopian Tube Cancers","Peritoneal Carcinoma","NOT_YET_RECRUITING","2026-08-14",{"date":137,"type":138},"2026-08-19","ACTUAL",{"date":140,"type":125},"2026-09",{"date":142,"type":125},"2029-01",{"name":111,"class":6},1]