[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602939":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"EuroCityClinic LLC","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NSCLC (n=60)","EXPERIMENTAL","The cohort of individuals with metastatic NSCLC will be treated with the reICB regimen (anti-PD(L)-1 antibodies+ cyclophosphamide+ bevacizumab) until disease progression or unacceptable toxicity.",[13],"Combination Product: reICB regimen (NSCLC)",{"label":15,"type":10,"description":16,"interventionNames":17},"melanoma (n=30)","The cohort of individuals with metastatic cutaneous melanoma will be treated with the reICB regimen (anti-PD(L)-1 antibodies+ cyclophosphamide+ bevacizumab) until disease progression or unacceptable toxicity.",[18],"Combination Product: reICB regimen (melanoma)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","reICB regimen (NSCLC)","* ICI (one of the following): Atezolizumab 1200 mg every 3 weeks\u002FNivolumab 240 mg every 2 weeks\u002FPembrolizumab 200 mg every 3 weeks\n* Cyclophosphamide 50 mg PO daily\n* Bevacizumab 7.5 mg\u002Fkg every 3 weeks",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"reICB regimen (melanoma)","* ICI (one of the following): Nivolumab 240 mg every 2 weeks\u002FPembrolizumab 200 mg every 3 weeks\n* Cyclophosphamide 50 mg PO daily\n* Bevacizumab 7.5 mg\u002Fkg every 3 weeks",[15],[31],{"name":32,"affiliation":5,"role":33},"Sergey V. Orlov, Professor","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+79811957915","orloff-sv@mail.ru",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Aram A. Musaelyan, PhD","+79990263455","a.musaelyan8@gmail.com",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Saint Petersburg","Sankt-Peterburg","197022","Russia","RU",{"type":52,"coordinates":53},"Point",[54,55],30.31413,59.93863,{"lat":55,"lon":54},[58],{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Aram Musaelyan","PhD, medical onсologist",[63],{"name":64,"class":65},"First Pavlov State Medical University in St. Petersburg, Russia","UNKNOWN","100602939","phase-2-efficacy-and-safety-of-anti-pd-1pd-l1-antibodies-in-combination-with-bevacizumab-and-metronomic-cyclophosphamide-in-patients-with-non-small-cell-lung-cancer-and-cutaneous-melanoma-previously-treated-with-immune-checkpoint-blockade-100602939",false,"NCT07130032","Efficacy And Safety Of Anti-PD-1\u002FPD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade","A Trial To Compare Efficacy And Safety Of Anti-PD-1\u002FPD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade","reICB","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Provide written informed consent\n* Age ≥ 18 years\n* Histologically confirmed diagnosis of NSCLC and cutaneous melanoma with distant metastases.\n* No mutations in the EGFR gene, ALK, ROS1, RET gene translocations (in case of NSCLC).\n* For NSCLC: the individuals had previously received anti-PD-(L)1 antibodies in combination with platinum-containing chemotherapy either in the first line or sequentially in the first and second lines for the treatment of metastatic disease.\n* For NSCLC: the individuals had previously received anti-PD-(L)1 antibodies for \\>6 months and experienced disease progression.\n* For cutaneous melanoma: the individuals had previously received anti-PD-1 antibodies either in combination with or without anti-CTLA4 therapy for metastatic disease. If the patient had the BRAF V600 mutation, they were also treated with BRAF and MEK inhibitors.\n* For cutaneous melanoma: the patient has previously received anti-PD-1 antibodies with or without anti-CTLA4 therapy for metastatic disease for \\>6 months and experienced disease progression\n\nExclusion Criteria:\n\n* Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III\u002FIV congestive heart failure, ventricular arrhythmias.\n* Stroke and\u002For transient ischemic attack within 6 months prior to screening;\n* Uncontrolled hypertension\n* History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is required during the study period. Patients having hepatic involvement of cancer should be excluded as per investigator assessment.\n* Patients with CNS metastases are eligible only if the metastases are adequately treated.\n* Absolute neutrophil count (ANC) \\\u003C1.5×109\u002FL, platelet count \\\u003C100×109\u002FL, or hemoglobin \\\u003C9.0 g\u002FdL.\n* Serum total bilirubin \\>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \\\u003C2 X ULN, and normal AST\u002FALT are eligible;\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 × ULN;\n* Serum creatinine \\>1.5 × ULN.\n* History of a thromboembolic event\n* Presence of any allergic reactions to components of the study drugs\n* Concomitant medications with a known risk of causing QT prolongation and\u002For Torsades de Pointes.\n* Any parallel anti-cancer systemic therapy, radiation therapy\n* Women who are pregnant or lactating;\n* Presence of unresolved adverse events of grade 2 or higher toxicity, according to CTCAE v5.0 criteria, from prior therapy (except for alopecia or neurotoxicity grade≤2).\n* Any other serious or uncontrolled medical disorder, active infection, physical examination finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a patient's ability to comply with the study requirements, substantially increase risk to the patient, or impact the interpretability of study results.","ALL","18 Years",{"count":77,"type":78},90,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This study will evaluate efficacy and safety of anti-PD-1\u002FPD-L1 antibodies combined with bevacizumab and metronomic cyclophosphamide in patients with metastatic non-small cell lung cancer (NSCLC) and cutaneous melanoma previously treated with immune checkpoint blockade (ICB). The hypotheses of this study are that a combination of ICB, cyclophosphamide, and bevacizumab prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.",[84,85],"Metastatic Non-small Cell Lung Cancer (NSCLC)","Metastatic Cutaneous Melanoma",[87,88,89,90,91],"Metastatic non-small cell lung cancer","Metastatic cutaneous melanoma","Immune checkpoint inhibitor","Bevacizumab","Metronomic cyclophosphamide","2025-08-14",{"date":94,"type":95},"2025-08-19","ACTUAL",{"date":92,"type":95},{"date":98,"type":78},"2027-12",{"name":5,"class":6},1]