[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613061":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":45,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":18,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":28,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Weekly Paclitaxel\u002FNab-Paclitaxel, Pembrolizumab, and Mirabegron","EXPERIMENTAL","Participants receive weekly paclitaxel\u002Fnab-paclitaxel plus pembrolizumab via intravenous (IV) infusion plus on Day 1 of each 21-day cycle orally with daily mirabegron until intolerance or disease progression.",[13],"Drug: Weekly Paclitaxel\u002FNab-Paclitaxel, Pembrolizumab, and Mirabegron",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Cao, Doctor","CONTACT","86 13301971027","caokankan@126.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Obstetrics and Gynecology Hospital of Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200090","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":43,"phoneExt":18,"email":44},"Wu, Doctor","86 13764046908","wuxin_fc@fudan.edu.cn",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Xin Wu","Director","100613061","phase-2-phase-ii-study-of-weekly-paclitaxelnab-paclitaxel-pembrolizumab-and-mirabegron-for-recurrent-ovarian-cancer-100613061",false,"NCT07261683","Phase II Study of Weekly Paclitaxel\u002FNab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer","A Phase II Study Evaluating the Efficacy and Safety of Weekly Paclitaxel or Nab-Paclitaxel Combined With Pembrolizumab and Mirabegron in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Has provided documented informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n* Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment).\n* Has a platinum-free interval (PFI) of \\\u003C 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of \\\u003C 12 months if the last regimen received is a non-platinum-based.\n* Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Has a life expectancy of ≥12 weeks.\n* Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.\n* Has adequate organ function.\n* Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.\n\nExclusion Criteria:\n\n* Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.\n* Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 \\[CTLA-4\\], tumor necrosis factor receptors OX-40 or CD137).\n* Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before enrollment.\n* Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to paclitaxel\u002Fnab-paclitaxel, pembrolizumab, mirabegron and any of their excipients.\n* Has undergone major surgery within 3 weeks before enrollment or has complications\u002Fsequelae that have not yet recovered.\n* Has a known additional malignancy that progressed or required active treatment within the last 5 years.\n* Is pregnant or breastfeeding.\n* Has a history of allogenic tissue\u002Fsolid organ transplant.\n* Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before enrollment.\n* Has a history of active autoimmune disease.\n* Has an active infection requiring systemic therapy.\n* Has a history of human immunodeficiency virus (HIV) infection.\n* Has a history of Hepatitis B or C virus infection.\n* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.","FEMALE","18 Years","75 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","The goal of this clinical trial is to learn if drug regimen weekly paclitaxel\u002Fnab-paclitaxel, pembrolizumab, and mirabegron works to treat relapsed ovarian cancer in adults. It will also learn about the safety of the drug regimen. The main questions it aims to answer are:\n\ni) Does drug weekly paclitaxel\u002Fnab-paclitaxel, pembrolizumab, and mirabegron reduce tumor volume? ii) What medical problems do participants have when taking drug weekly paclitaxel\u002Fnab-paclitaxel, pembrolizumab, and mirabegron?\n\nParticipants will:\n\ni) Take drug paclitaxel\u002Fnab-paclitaxel every week and pembrolizumab every 21 days with everyday mirabegron ii) Visit the clinic once every 2 months for checkups and tests iii) Keep a diary of their symptoms",[67,68,69],"Ovarian Cancer","Immunotherapy","Pembrolizumab",[71,72],"ovarian cancer","immunotherapy","2025-12-14",{"date":75,"type":76},"2025-12-19","ACTUAL",{"date":78,"type":61},"2025-12",{"date":80,"type":61},"2028-11-30",{"name":5,"class":6},1]