[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517560":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":90,"centralContacts":95,"locations":105,"responsibleParty":466,"collaborators":470,"id":473,"slug":474,"hasResults":475,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":475,"sex":481,"minAge":482,"maxAge":69,"enrollmentInfo":483,"targetDuration":69,"studyType":486,"phases":487,"briefSummary":489,"conditions":490,"keywords":495,"overallStatus":108,"whyStopped":69,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":510},{"fullName":5,"class":6},"German Society for Pediatric Oncology and Hematology GPOH gGmbH","OTHER",[8,21,25,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients \u003C 26 years with non-metastatic disease with CR or PR after induction therapy","EXPERIMENTAL","Participants receive Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg\u002Fm2 on day 1, plus 5-fluorouracil 1,000 mg\u002Fm2\u002Fd from day 1-5.\n\nAfter induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy in patients with PR or a reduced boost at 54Gy in patients with CR. Cisplatin will be administered at 3x20mg\u002Fm2 in the first and last week of radiotherapy, each.\n\nRadiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU\u002Fweek s.c. for 6 months.",[13,14,15,16,17,18,19,20],"Drug: Nivolumab","Drug: Cisplatin","Drug: 5-Fluorouracil","Radiation: Radiotherapy","Drug: Interferon beta-1a","Procedure: MRI","Procedure: PET","Behavioral: Patient-Reported Outcomes",{"label":22,"type":10,"description":23,"interventionNames":24},"Patients \u003C 26 y with no metastases and SD or PD after induction therapy or patients with metastases","Participants receive Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg\u002Fm2 on day 1, plus 5-fluorouracil 1,000 mg\u002Fm2\u002Fd from day 1-5. Patients with metastases responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.\n\nAfter induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy. Cisplatin will be administered at 3x20mg\u002Fm2 in the first and last week of radiotherapy, each. Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.\n\nRadiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU\u002Fweek s.c. for 6 months.",[13,14,15,16,17,18,19,20],{"label":26,"type":10,"description":27,"interventionNames":28},"Patients >25 years with non-metastatic disease with CR or PR after induction therapy","Participants receive Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg\u002Fm2 on day 1, plus 5-fluorouracil 1,000 mg\u002Fm2\u002Fd from day 1-5.\n\nAfter induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO).",[13,14,15,16,18,19,20],{"label":30,"type":10,"description":31,"interventionNames":32},"Patients > 25 years with non-metastatic disease with SD or PD after induction therapy","Participants receive Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg\u002Fm2 on day 1, plus 5-fluorouracil 1,000 mg\u002Fm2\u002Fd from day 1-5.\n\nAfter induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.",[13,14,15,16,18,19,20],{"label":34,"type":10,"description":35,"interventionNames":36},"Patients > 25 years with metastatic disease at diagnosis","Participants receive Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 80 mg\u002Fm2 on day 1, plus gemcitabine 1,000 mg\u002Fm2\u002Fd on day 1 and day 8, respectively. Patients responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.\n\nAfter induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg\u002Fkg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.",[13,14,37,16,18,19,20],"Drug: Gemcitabine",[39,46,52,58,64,70,76,81,85],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Nivolumab","Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases",[22,9,34,30,26],[45],"Opdivo",{"type":40,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Cisplatin","Cisplatin during induction chemotherapy and during radiochemotherapy in all groups",[22,9,34,30,26],[51],"Cisplatin Teva",{"type":40,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"5-Fluorouracil","5-Fluoruracil during induction chemotherapy in all groups except of adults \\> 25 years with metastatic disease at diagnosis",[22,9,30,26],[57],"Fluorouracil-GRY",{"type":40,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Gemcitabine","Gemcitabine during induction chemotherapy in patients \\> 25 years with metastatic disease at diagnosis",[34],[63],"Gemcitabin-GRY",{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"RADIATION","Radiotherapy","After induction therapy in all patients",[22,9,34,30,26],null,{"type":40,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Interferon beta-1a","In patients \\\u003C 26 years after end of radiochemotherapy for 6 months",[22,9],[75],"Rebif",{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":69},"PROCEDURE","MRI","At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy",[22,9,34,30,26],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":69},"PET","At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI",[22,9,34,30,26],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":69},"BEHAVIORAL","Patient-Reported Outcomes","For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment",[22,9,34,30,26],[91],{"name":92,"affiliation":93,"role":94},"Udo Kontny, MD","Uniklinik RWTH Aachen","PRINCIPAL_INVESTIGATOR",[96,101],{"name":97,"role":98,"phone":99,"phoneExt":69,"email":100},"Helena Kerp, PhD","CONTACT","+49 201 74 94 96 14","h.kerp@forschung-paediatrie.de",{"name":102,"role":98,"phone":103,"phoneExt":69,"email":104},"Tristan Römer, MD.","+49 241 80 38063","troemer@ukaachen.de",[106,124,130,139,148,163,177,191,200,205,214,228,233,247,257,271,285,294,308,322,336,350,360,369,383,397,406,420,429,443,457],{"facility":107,"status":108,"city":109,"state":69,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Uniklinik RWTH Aachen, Department of Internal Medicine","RECRUITING","Aachen","52074","Germany","DE",{"type":114,"coordinates":115},"Point",[116,117],6.08342,50.77664,{"lat":117,"lon":116},[120],{"name":121,"role":98,"phone":122,"phoneExt":69,"email":123},"Mareike Tometten, MD","0241-80-80703","mtometten@ukaachen.de",{"facility":125,"status":126,"city":109,"state":69,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":127,"geoPoint":129,"contacts":69},"Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation","ACTIVE_NOT_RECRUITING",{"type":114,"coordinates":128},[116,117],{"lat":117,"lon":116},{"facility":131,"status":126,"city":132,"state":69,"zip":133,"country":111,"countryCode":112,"cosmosGeoPoint":134,"geoPoint":138,"contacts":69},"Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin","Berlin","13353",{"type":114,"coordinates":135},[136,137],13.41053,52.52437,{"lat":137,"lon":136},{"facility":140,"status":126,"city":141,"state":69,"zip":142,"country":111,"countryCode":112,"cosmosGeoPoint":143,"geoPoint":147,"contacts":69},"Evangelisches Klinikum Bethel, Children's Hospital","Bielefeld","33617",{"type":114,"coordinates":144},[145,146],8.53333,52.03333,{"lat":146,"lon":145},{"facility":149,"status":150,"city":151,"state":69,"zip":152,"country":111,"countryCode":112,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Department of Pediatric Hematology and Oncology, University Hospital","NOT_YET_RECRUITING","Bonn","53127",{"type":114,"coordinates":154},[155,156],7.09549,50.73438,{"lat":156,"lon":155},[159],{"name":160,"role":98,"phone":161,"phoneExt":69,"email":162},"Dagmar Dilloo, MD","+49-228-287-33215","dagmar.dilloo@ukbonn.de",{"facility":164,"status":108,"city":165,"state":69,"zip":166,"country":111,"countryCode":112,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne","Cologne","50937",{"type":114,"coordinates":168},[169,170],6.95,50.93333,{"lat":170,"lon":169},[173],{"name":174,"role":98,"phone":175,"phoneExt":69,"email":176},"Jens Klußmann, MD","+49-221-4784750","jens.klussmann@uk-koeln.de",{"facility":178,"status":108,"city":179,"state":69,"zip":180,"country":111,"countryCode":112,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Children's Hospital, Carl-Thiem Klinikum Cottbus","Cottbus","03048",{"type":114,"coordinates":182},[183,184],14.32888,51.75769,{"lat":184,"lon":183},[187],{"name":188,"role":98,"phone":189,"phoneExt":69,"email":190},"Georg Schwabe, MD","+49-355-46-2336","G.Schwabe@ctk.de",{"facility":192,"status":126,"city":193,"state":69,"zip":194,"country":111,"countryCode":112,"cosmosGeoPoint":195,"geoPoint":199,"contacts":69},"Clinic for Children and Adolescent Medicine, Klinikum Dortmund","Dortmund","44145",{"type":114,"coordinates":196},[197,198],7.466,51.51494,{"lat":198,"lon":197},{"facility":201,"status":126,"city":193,"state":69,"zip":194,"country":111,"countryCode":112,"cosmosGeoPoint":202,"geoPoint":204,"contacts":69},"Department of Internal Medicine, Klinikum Dortmund",{"type":114,"coordinates":203},[197,198],{"lat":198,"lon":197},{"facility":206,"status":126,"city":207,"state":69,"zip":208,"country":111,"countryCode":112,"cosmosGeoPoint":209,"geoPoint":213,"contacts":69},"Department of Pediatrics, University Hospital, Technische Universität Dresden","Dresden","01307",{"type":114,"coordinates":210},[211,212],13.73832,51.05089,{"lat":212,"lon":211},{"facility":215,"status":108,"city":216,"state":69,"zip":217,"country":111,"countryCode":112,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Department fo Radiotherapy, University Hospital","Erlangen","91054",{"type":114,"coordinates":219},[220,221],11.00783,49.59099,{"lat":221,"lon":220},[224],{"name":225,"role":98,"phone":226,"phoneExt":69,"email":227},"Marlen Haderlein, MD","+49-9131-8533405","st-studiensekretariat@uk-erlangen.de",{"facility":229,"status":126,"city":216,"state":69,"zip":217,"country":111,"countryCode":112,"cosmosGeoPoint":230,"geoPoint":232,"contacts":69},"Department of Pediatrics, University Hospital Erlangen",{"type":114,"coordinates":231},[220,221],{"lat":221,"lon":220},{"facility":234,"status":150,"city":235,"state":69,"zip":236,"country":111,"countryCode":112,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Department of Medical Oncology, West German Cancer Center, University Hospital Essen","Essen","45147",{"type":114,"coordinates":238},[239,240],7.01228,51.45657,{"lat":240,"lon":239},[243],{"name":244,"role":98,"phone":245,"phoneExt":69,"email":246},"Stefan Kasper-Virchow, MD","+49-201-72384150","WTZI-Studie@uk-essen.de",{"facility":248,"status":150,"city":235,"state":69,"zip":236,"country":111,"countryCode":112,"cosmosGeoPoint":249,"geoPoint":251,"contacts":252},"Department of Pediatric Hematology and Oncology, University Hospital Essen",{"type":114,"coordinates":250},[239,240],{"lat":240,"lon":239},[253],{"name":254,"role":98,"phone":255,"phoneExt":69,"email":256},"Stefan Schönberger, MD","+49-201-723-85190.","Stefan.Schoenberger@uk-essen.de",{"facility":258,"status":150,"city":259,"state":69,"zip":260,"country":111,"countryCode":112,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Department of Pediatrics, University Hospital","Frankfurt","60590",{"type":114,"coordinates":262},[263,264],10.53333,49.68333,{"lat":264,"lon":263},[267],{"name":268,"role":98,"phone":269,"phoneExt":69,"email":270},"Konrad Bochennek, MD","+49-69-6301-4157","Konrad.Bochennek@kgu.de",{"facility":272,"status":150,"city":273,"state":69,"zip":274,"country":111,"countryCode":112,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Department of Pediatric Hematology\u002FOncology, University Hospital Freiburg","Freiburg im Breisgau","79106",{"type":114,"coordinates":276},[277,278],7.85222,47.9959,{"lat":278,"lon":277},[281],{"name":282,"role":98,"phone":283,"phoneExt":69,"email":284},"Simone Hettmer, MD","+49-761-270-46940","simone.hettmer@uniklinik-freiburg.de",{"facility":286,"status":126,"city":287,"state":69,"zip":288,"country":111,"countryCode":112,"cosmosGeoPoint":289,"geoPoint":293,"contacts":69},"Department of Pediatric Oncology, Justus-Liebig University of Giessen","Giessen","35392",{"type":114,"coordinates":290},[291,292],8.67554,50.58727,{"lat":292,"lon":291},{"facility":295,"status":150,"city":296,"state":69,"zip":297,"country":111,"countryCode":112,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Department of Pediatric Oncology, University Hospital","Göttingen","37075",{"type":114,"coordinates":299},[300,301],9.93228,51.53443,{"lat":301,"lon":300},[304],{"name":305,"role":98,"phone":306,"phoneExt":69,"email":307},"Christof Kramm, MD","+49-551-39-63081","paedonko@med.uni-goettingen.de",{"facility":309,"status":150,"city":310,"state":69,"zip":311,"country":111,"countryCode":112,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Department of Pediatric Hematology\u002FOncology, University Medicine Greifswald","Greifswald","17475",{"type":114,"coordinates":313},[314,315],13.40244,54.08905,{"lat":315,"lon":314},[318],{"name":319,"role":98,"phone":320,"phoneExt":69,"email":321},"Karoline Ehlert, MD","+49-3834-866325","karoline.ehlert@med.uni-greifswald.de",{"facility":323,"status":108,"city":324,"state":69,"zip":325,"country":111,"countryCode":112,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Universitätsklinikum Halle, Klinik für Pädiatrie I","Halle","06120",{"type":114,"coordinates":327},[328,329],11.97947,51.48158,{"lat":329,"lon":328},[332],{"name":333,"role":98,"phone":334,"phoneExt":69,"email":335},"Jessica Höll, MD","+49-345-557-2388","Jessica.Hoell@uk-halle.de",{"facility":337,"status":108,"city":338,"state":69,"zip":339,"country":111,"countryCode":112,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Department of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf,","Hamburg","20246",{"type":114,"coordinates":341},[342,343],9.99302,53.55073,{"lat":343,"lon":342},[346],{"name":347,"role":98,"phone":348,"phoneExt":69,"email":349},"Henrike Zech, MD","+49-407-410-52364","hzech@uke.de",{"facility":351,"status":108,"city":338,"state":69,"zip":69,"country":111,"countryCode":112,"cosmosGeoPoint":352,"geoPoint":354,"contacts":355},"Department of Pediatric Oncology, University Children's Hospital",{"type":114,"coordinates":353},[342,343],{"lat":343,"lon":342},[356],{"name":357,"role":98,"phone":358,"phoneExt":69,"email":359},"Uwe Kordes, MD","+49-40-7410-53796","u.kordes@uke.de",{"facility":361,"status":126,"city":362,"state":69,"zip":363,"country":111,"countryCode":112,"cosmosGeoPoint":364,"geoPoint":368,"contacts":69},"Department of Otorhinolaryngology, Jena University Hospital","Jena","07743",{"type":114,"coordinates":365},[366,367],11.5899,50.92878,{"lat":367,"lon":366},{"facility":370,"status":108,"city":371,"state":69,"zip":372,"country":111,"countryCode":112,"cosmosGeoPoint":373,"geoPoint":377,"contacts":378},"Department of Pediatric Oncology, University Hospital Kiel","Kiel","24105",{"type":114,"coordinates":374},[375,376],10.13489,54.32133,{"lat":376,"lon":375},[379],{"name":380,"role":98,"phone":381,"phoneExt":69,"email":382},"Simon Vieth, MD","+49-431-500-20119","Simon.Vieth@uksh.de",{"facility":384,"status":150,"city":385,"state":69,"zip":386,"country":111,"countryCode":112,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"Department of Pediatrics, University Hospital Mageburg","Magdeburg","39120",{"type":114,"coordinates":388},[389,390],11.63189,52.13129,{"lat":390,"lon":389},[393],{"name":394,"role":98,"phone":395,"phoneExt":69,"email":396},"Antje Redlich, MD","+49-391-67-24235","Antje.Redlich@med.ovgu.de",{"facility":398,"status":126,"city":399,"state":69,"zip":400,"country":111,"countryCode":112,"cosmosGeoPoint":401,"geoPoint":405,"contacts":69},"Pediatric Hematology\u002FOncology, University Medicine Mainz","Mainz","55131",{"type":114,"coordinates":402},[403,404],8.28008,49.98185,{"lat":404,"lon":403},{"facility":407,"status":108,"city":408,"state":69,"zip":409,"country":111,"countryCode":112,"cosmosGeoPoint":410,"geoPoint":414,"contacts":415},"Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim,","Mannheim","68167",{"type":114,"coordinates":411},[412,413],8.46694,49.4891,{"lat":413,"lon":412},[416],{"name":417,"role":98,"phone":418,"phoneExt":69,"email":419},"Annette Affolter, MD","+49-621-383-3965","annette.affolter@umm.de",{"facility":421,"status":126,"city":422,"state":69,"zip":423,"country":111,"countryCode":112,"cosmosGeoPoint":424,"geoPoint":428,"contacts":69},"Department of Pediatric Hematology and Oncology, University Children's Hospital","Münster","48149",{"type":114,"coordinates":425},[426,427],7.62571,51.96236,{"lat":427,"lon":426},{"facility":430,"status":150,"city":431,"state":69,"zip":432,"country":111,"countryCode":112,"cosmosGeoPoint":433,"geoPoint":437,"contacts":438},"Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital","Regensburg","93053",{"type":114,"coordinates":434},[435,436],12.10161,49.01513,{"lat":436,"lon":435},[439],{"name":440,"role":98,"phone":441,"phoneExt":69,"email":442},"Marcus Jakob, MD","+49-941-944-2101","Marcus.Jakob@klinik.uni-regensburg.de",{"facility":444,"status":108,"city":445,"state":69,"zip":446,"country":111,"countryCode":112,"cosmosGeoPoint":447,"geoPoint":451,"contacts":452},"Universitätsklinikum Tübingen, Klinik für Pädiatrie I","Tübingen","72076",{"type":114,"coordinates":448},[449,450],9.05222,48.52266,{"lat":450,"lon":449},[453],{"name":454,"role":98,"phone":455,"phoneExt":69,"email":456},"Ines Brecht, MD","+49-7071-29-83773","Ines.Brecht@med.uni-tuebingen.de",{"facility":458,"status":126,"city":459,"state":69,"zip":460,"country":111,"countryCode":112,"cosmosGeoPoint":461,"geoPoint":465,"contacts":69},"Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital, University of Würzburg","Würzburg","97080",{"type":114,"coordinates":462},[463,464],9.95121,49.79391,{"lat":464,"lon":463},{"type":94,"investigatorFullName":467,"investigatorTitle":468,"investigatorAffiliation":469,"oldNameTitle":69,"oldOrganization":69},"Prof. Dr. Udo Kontny","Head, Div. Pediatric Hematology, Oncology, Stem Cell Transplantation","RWTH Aachen University",[471],{"name":472,"class":6},"Deutsche Krebshilfe e.V., Bonn (Germany)","100517560","phase-2-nivolumab-in-children-and-adults-with-nasopharyngeal-carcinoma-100517560",false,"NCT06019130","Nivolumab in Children and Adults With Nasopharyngeal Carcinoma","Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma","NPC-Nivo","Inclusion Criteria:\n\n1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged between 3 years and 17 years, OR histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma, WHO stage II or III, in subjects ≥ 18 years\n2. Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients \\> 25 years of age (AJCC, 8th edition)\n3. Measurable disease by MRI per RECIST 1.1 criteria\n4. Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 1 or 2 full blocks (preferred) or a minimum of 25 slides, obtained from core biopsy, punch biopsy, excisional biopsy or surgical specimen\n5. Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation\n\nExclusion Criteria:\n\n1. Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients \\> 25 years of age\n2. Recurrent nasopharyngeal carcinoma\n3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and\u002For radiotherapy\n4. Prior chemotherapy and\u002For radiotherapy\n5. Other active malignancy\n6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n7. The subject received an investigational drug within 30 days prior to inclusion into this study\n8. Subjects who are enrolled in another clinical trial\n9. Subjects with prior organ allograft or allogenic bone marrow transplantation\n10. Subjects with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.\n11. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n12. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n14. Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values:\n\n    1. WBC \\\u003C 2 000\u002Fµl\n    2. Neutrophils \\\u003C 1 500\u002Fµl\n    3. Platelets \\\u003C 100 x 10e3\u002FµL\n    4. Hemoglobin \\\u003C 9.0 g\u002FdL\n    5. Creatinine \\>1.5 x ULN or creatinine clearance \\\u003C 50 mL\u002Fmin (using the Cockcroft Gault formula or Schwartz formula in patients \\\u003C 18 years)\n    6. AST\u002FALT \\> 3 x ULN (\\> 5 x ULN if liver metastases)\n    7. Total Bilirubin \\> 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 x ULN)\n15. Hearing loss \\> 20 dB loss at 3 kHz due to an inner ear disorder and not caused by tumour burden\n16. History of allergy or hypersensitivity to platinum-containing compounds or other study drug components\n17. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).\n18. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug.\n19. Adequate performance status (Karnofsky score ≥ 60 for patients (age ≥ 16), Lansky score ≥ 60 (age \\\u003C 16).\n20. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.\n21. The subject has any current or past medical condition and\u002For required medication to treat a condition that could affect the evaluation of the study.\n22. Pregnant females as determined by positive \\[serum or urine\\] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol. (Please refer to section 4.4)\n23. Lactating females\n24. Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n25. The subject is unwilling or unable to follow the procedures outlined in the protocol\n26. The subject is mentally or legally incapacitated.","ALL","3 Years",{"count":484,"type":485},57,"ESTIMATED","INTERVENTIONAL",[488],"PHASE2","The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.",[491,492,493,494],"Nasopharyngeal Carcinoma","Nasopharyngeal Cancer","Nasopharyngeal Neoplasms","Nasopharynx Cancer",[496,41,497,498,499,500],"Immunotherapy","Children","Adults","Chemotherapy","Immune Checkpoint Inhibitor","2024-05-14",{"date":503,"type":504},"2024-05-16","ACTUAL",{"date":506,"type":504},"2023-01-10",{"date":508,"type":485},"2028-01-09",{"name":5,"class":6},31]