[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629244":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":35,"studyPopulation":35,"armGroups":48,"interventions":63,"overallOfficials":35,"centralContacts":77,"locations":86,"responsibleParty":103,"collaborators":35,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":35,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":35,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":35,"overallStatus":89,"whyStopped":35,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"N.N. Alexandrov National Cancer Centre","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Overall survival","Time from randomization to the death of any cause","From enrollment through study completion, an average of 2 year",{"measure":14,"description":15,"timeFrame":16},"Median overall survival","The timepoint at which 50% of patients are still alive following treatment initiation","From date of treatment initiation until the date of death from any cause, assessed up to 36 months",[18,22,26,29],{"measure":19,"description":20,"timeFrame":21},"Objective response rate","The percentage of patients whose cancer shrinks or disappears (complete or partial response) after treatment","From randomization until progression or study completion, average of 60 months",{"measure":23,"description":24,"timeFrame":25},"Duration of response","The length of time from the first sign of a treatment response (partial or complete) until disease progression or death","From date of first documented response until progression or death, assessed up to 60 months",{"measure":27,"description":28,"timeFrame":12},"Disease-free survival","Time from randomization to any sign or symptom of the cancer or death from the disease",{"measure":30,"description":31,"timeFrame":16},"Median Disease-free survival","The time at which 50% of patients remain alive without any signs or symptoms of cancer",[33,37],{"measure":34,"description":35,"timeFrame":36},"The frequency of immune-related adverse events",null,"Through From date of first immunotherapy dose through 60 months, or date of last patient contact",{"measure":38,"description":35,"timeFrame":39},"The frequency of discontinuation of immunotherapy","From date of first immunotherapy dose through 60 months, or date of last patient contact",{"allocation":41,"interventionModel":42,"interventionModelDescription":35,"primaryPurpose":43,"observationalModel":35,"timePerspective":35,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":35,"whoMasked":46},"SINGLE",[47],"PARTICIPANT",[49,54,58],{"label":50,"type":51,"description":35,"interventionNames":52},"PD-1","EXPERIMENTAL",[53],"Drug: PD-1 antibody",{"label":55,"type":51,"description":35,"interventionNames":56},"PD-L1",[57],"Drug: PD-L1 antibody",{"label":59,"type":60,"description":35,"interventionNames":61},"Standard","ACTIVE_COMPARATOR",[62],"Drug: Chemotherapy and bevacizumab (CT-BEV)",[64,69,73],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":35},"DRUG","PD-1 antibody","Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg\u002Fm2 or carboplatin AUC 5-6 + paclitaxel 175 mg\u002Fm2 + PD-1 inhibitor ± bevacizumab 7-10 mg\u002Fkg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-1 inhibitor ± bevacizumab 7-10 mg\u002Fkg every 21 days.",[50],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":35},"PD-L1 antibody","Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg\u002Fm2 or carboplatin AUC 5-6 + paclitaxel 175 mg\u002Fm2 + PD-L1 inhibitor ± bevacizumab 7-10 mg\u002Fkg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-L1 inhibitor ± bevacizumab 7-10 mg\u002Fkg every 21 days.",[55],{"type":65,"name":74,"description":75,"armGroupLabels":76,"otherNames":35},"Chemotherapy and bevacizumab (CT-BEV)","Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg\u002Fm2 or carboplatin AUC 5-6 + paclitaxel 175 mg\u002Fm2 ± bevacizumab 7-10 mg\u002Fkg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of bevacizumab 7-10 mg\u002Fkg every 21 days.",[59],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":35,"email":82},"Yana Kamko","CONTACT","80259111218","kazache.yana@gmail.com",{"name":84,"role":80,"phone":35,"phoneExt":35,"email":85},"Sergey Mavrichev","smavrichev71@gmail.com",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"N.N. Alexandrov National Caner Centre","RECRUITING","Minsk","Lesnoy","223040","Belarus","BY",{"type":96,"coordinates":97},"Point",[98,99],27.56653,53.90019,{"lat":99,"lon":98},[102],{"name":79,"role":80,"phone":81,"phoneExt":35,"email":82},{"type":104,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100629244","phase-2-pd-1-programmed-death-1-versus-pd-l1-programmed-death-ligand-1-immune-check-point-inhibitors-combined-with-chemotherapy-with-or-without-bevacizumab-in-patients-with-metastatic-persistent-or-recurrent-cervical-cancer-100629244",false,"NCT07472153","PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemotherapy, With or Without Bevacizumab, In Patients With Metastatic, Persistent Or Recurrent Cervical Cancer","To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy","Inclusion Criteria:\n\n* Age ≥18-≤75 years.\n* Histologically confirmed diagnosis.\n* One of the forms of the cervical cancer:\n\n  1. Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);\n  2. Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);\n  3. Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018).\n* Availability of material for determining PD-L-1 expression for immunotherapy candidates.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No contraindications to chemotherapy, immunotherapy, or bevacizumab.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of another active malignant invasive neoplasm.\n* Pregnancy or lactation period.","FEMALE","18 Years","75 Years",{"count":116,"type":117},120,"ESTIMATED","INTERVENTIONAL",[120,121],"PHASE2","PHASE3","This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.",[124,125,126],"Metastatic Cervical Cancer","Persistent Cervical Cancer","Recurrent Cervical Cancer","2026-05-26",{"date":129,"type":130},"2026-05-28","ACTUAL",{"date":132,"type":130},"2025-07-01",{"date":134,"type":117},"2033-06-30",{"name":5,"class":6},1]