[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429710":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":22,"responsibleParty":81,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":11,"enrollmentInfo":96,"targetDuration":11,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":11,"overallStatus":25,"whyStopped":11,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental therapy:OPDIVO (Nivolumab)","EXPERIMENTAL",null,[13],"Drug: Opdivo",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Opdivo","Dose of Nivolumab is constant and is 240 mg .All patients will undergo maximum of 12 cycles of investigation product's infusion ( around 6 month of treatment).Each cycle will be done in intervals of 14 day (no less than 12 days after previous infusion and no longer than 42 day\u002F6 weeks after previous infusion).",[9],[21],"Nivolumab",[23,41,54,68],{"facility":24,"status":25,"city":26,"state":11,"zip":11,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku","RECRUITING","Bialystok","Poland","PL",{"type":30,"coordinates":31},"Point",[32,33],23.16433,53.13333,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Ewa Sierko, dr hab.n. med.","CONTACT","856646720","esierko@onkologia.bialystok.pl",{"facility":42,"status":25,"city":43,"state":11,"zip":11,"country":27,"countryCode":28,"cosmosGeoPoint":44,"geoPoint":48,"contacts":49},"Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego","Gdansk",{"type":30,"coordinates":45},[46,47],18.64912,54.35227,{"lat":47,"lon":46},[50],{"name":51,"role":38,"phone":52,"phoneExt":11,"email":53},"Rafał Dziadziuszko, Prof.dr hab.n.med.","585844510","rafald@gumed.edu.pl",{"facility":55,"status":25,"city":56,"state":11,"zip":57,"country":27,"countryCode":28,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach","Gliwice","44-101",{"type":30,"coordinates":59},[60,61],18.67658,50.29761,{"lat":61,"lon":60},[64],{"name":65,"role":38,"phone":66,"phoneExt":11,"email":67},"Tomasz Rutkowski, Dr hab. n.med.","604077641","Tomasz.rutkowski@io.gliwice.pl",{"facility":69,"status":25,"city":70,"state":11,"zip":11,"country":27,"countryCode":28,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii","Kielce",{"type":30,"coordinates":72},[73,74],20.62752,50.87033,{"lat":74,"lon":73},[77],{"name":78,"role":38,"phone":79,"phoneExt":11,"email":80},"Piotr Kędzierawski, dr n. med.","413674740","piotrkedzierawski@wp.pl",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[84],{"name":85,"class":6},"KCRI","100429710","phase-2-nivolumab-in-nasopharyngeal-cancer-with-progression-during-or-after-platinum-based-treatment-100429710",false,"NCT04875611","Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment","Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy","NIVONASO-21","Inclusion Criteria:\n\n1. Age \\> 18 years old\n2. Histological or cytological documentation of squamous cell carcinoma.\n3. Primary tumor location in nasopharynx\n4. Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy\n5. Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy\n6. ECOG(Eastern Cooperative Oncology Group) performance scale 0-1\n7. Participant is willing and able to give informed consent for participation in the study and agrees to undergo all follow up visit and planned procedures.\n\nExclusion Criteria:\n\n1. Known active central nervous system metastases.\n2. Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) \\\u003C 30 ml\u002Fmin\u002Fm2\n3. Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and \u002For ALT(alanine aminotransferase) \\> 2,5 x ULN(upper limits of normal) (\\> 5 x ULN in patients with documented liver metastases); total bilirubin \\> 1,5 xULN ( bilirubin \\> 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \\\u003C 35%) or albumin \\\u003C 2,5 g\u002FdL\n4. Abnormalities in blood count such as: hemoglobin \\\u003C 9 g\u002Fdl, platelets \\\u003C 100 x 109 \u002FL, Absolute Neutrophil Count (ANC) \\\u003C1,0 x 109 \u002FL\n5. Ejection fraction in echocardiography \\\u003C 50%\n6. History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.\n7. Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.\n8. Pregnancy or breastfeeding.\n9. Female with childbearing potential or male participant with female partner of childbearing potential, who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period and for 5 months after the end of treatment (last infusion)\n10. Prior therapy with an anti-PD-1\u002FL1\u002FL2 and\u002For anti-ICOS directed agent\n11. Patient is currently participating in another clinical trial.\n12. Active infection, which significantly affects the patient's clinical condition and requires treatment.\n13. Patient with prior bone marrow or solid organ transplantation.\n14. Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent \\> 10 mg)\n15. Known immunodeficiency including HIV\u002FAIDS(human immunodeficiency virus\u002Facquired immunodeficiency syndrome) infection.\n16. Patient received any live vaccine within 28 days before enrollment.\n17. Heart Failure - NYHA(New York Heart Association functional classification system) III or IV\n18. Coexistence of active malignant tumor or history of malignant tumor after radical treatment with disease-free period \\> 2 years, except: cervical cancer in situ\u002F basocellular skin cancer\u002Fprostate cancer, after radical treatment.\n19. Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.","ALL","18 Years",{"count":97,"type":98},32,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.",[104],"Nasopharyngeal Cancer","2025-04-21",{"date":107,"type":108},"2025-04-24","ACTUAL",{"date":110,"type":108},"2021-08-26",{"date":112,"type":98},"2025-12-31",{"name":5,"class":6},4]