[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510882":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":123,"collaborators":31,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":31,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":31,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: AK104","EXPERIMENTAL","AK104 monotherapy",[13],"Drug: AK104",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B: AK104+chemotherapy","AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)",[18],"Drug: AK104+ Paclitaxel+Cisplatin or Carboplatin",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AK104","AK104 15mg\u002Fkg intravenously(IV) every 3 weeks (Q3W), until progressive disease, unacceptable toxicity, completion of 2 years treatment or withdrawal of consent.",[9],[26],"Cadonilimab",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"AK104+ Paclitaxel+Cisplatin or Carboplatin","AK104 (10 mg\u002Fkg) + paclitaxel (175 mg\u002Fm2)+ cisplatin (50 mg\u002Fm2) or carboplatin (AUC 4-5) , IV, Q3W, for up to 6 cycles, followed by maintenance therapy of AK104 10 mg\u002Fkg Q3W until disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years treatment.",[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Ting Liu, MD","CONTACT","+86(0760)89873999","clinicaltrials@akesobio.com",[39,57,70,84,97,110],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Clinical oncology school of Fujian Medical University, Fujian Cancer Hospital","RECRUITING","Fuzhou","Fujian","350000","China","CN",{"type":48,"coordinates":49},"Point",[50,51],119.30611,26.06139,{"lat":51,"lon":50},[54],{"name":55,"role":56,"phone":31,"phoneExt":31,"email":31},"Yang Sun, MD","PRINCIPAL_INVESTIGATOR",{"facility":58,"status":41,"city":59,"state":60,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Sun Yant-Sen Memorial Hospital","Guangzhou","Guangdong","510000",{"type":48,"coordinates":63},[64,65],113.25,23.11667,{"lat":65,"lon":64},[68],{"name":69,"role":56,"phone":31,"phoneExt":31,"email":31},"Tingting Yao, MD",{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":45,"countryCode":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"The Fourth Hospital of Hebei Medical University","NOT_YET_RECRUITING","Shijiangzhuang","Hebei","050000",{"type":48,"coordinates":77},[78,79],118.28833,39.40013,{"lat":79,"lon":78},[82],{"name":83,"role":56,"phone":31,"phoneExt":31,"email":31},"Shuhuai Niu, MD",{"facility":85,"status":41,"city":86,"state":87,"zip":88,"country":45,"countryCode":46,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Liaoning Cancer Hospital & Insitut","Shenyang","Liaoning","110042",{"type":48,"coordinates":90},[91,92],123.43278,41.79222,{"lat":92,"lon":91},[95],{"name":96,"role":56,"phone":31,"phoneExt":31,"email":31},"Danbo Wang, MD",{"facility":98,"status":41,"city":99,"state":100,"zip":101,"country":45,"countryCode":46,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Tianjin medical university Cancer Institut & Hospital","Tianjin","Tianjin Municipality","300000",{"type":48,"coordinates":103},[104,105],117.17667,39.14222,{"lat":105,"lon":104},[108],{"name":109,"role":56,"phone":31,"phoneExt":31,"email":31},"Ke Wang, MD",{"facility":111,"status":72,"city":112,"state":113,"zip":114,"country":45,"countryCode":46,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang","310022",{"type":48,"coordinates":116},[117,118],120.16142,30.29365,{"lat":118,"lon":117},[121],{"name":122,"role":56,"phone":31,"phoneExt":31,"email":31},"Xiaojuan Lv, MD",{"type":124,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100510882","phase-2-ak104-for-recurrent-or-metastatic-vulvar-cancer-100510882",false,"NCT05932212","AK104 for Recurrent or Metastatic Vulvar Cancer","A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer","Inclusion Criteria:\n\nAge \\>=18 and \\\u003C=80. ECOG of 0 or 2. Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy.\n\nFor Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy.\n\nAt least one measurable tumor lesion per RECIST v1.1. Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception\n\nExclusion Criteria:\n\nSubjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc.\n\nSystemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration.\n\nPrevious treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.).\n\nActive or potentially recurrent autoimmune disease.","FEMALE","18 Years","80 Years",{"count":136,"type":137},20,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.",[143],"Vulvar Cancer",[145,146],"PD-1\u002FCTLA-4","vulvar cancer","2025-03-10",{"date":149,"type":150},"2025-03-12","ACTUAL",{"date":152,"type":150},"2023-08-25",{"date":154,"type":137},"2025-12-15",{"name":5,"class":6},6]