Spots Global Cancer Trial Database for Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
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Trial Identification
Brief Title: Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
Official Title: Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma
Study ID: NCT06019130
Study Description
Brief Summary: 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.
Detailed Description: After being informed about the study and potential risks, all patients will undergo a 2-week screening period to determine eligibility for study entry. After informed consent has been obtained, all patients ≤ 25 years and patients \> 25 years without metastases will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to standard induction chemotherapy (3 blocks of cisplatin/5-fluorouracil). In patients not responding to induction chemotherapy, the application of Nivolumab will be extended throughout the period of radiochemotherapy. Patients \> 25 years with metastatic disease will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to induction chemotherapy with 3 blocks of cisplatin/gemcitabine. All patients with metastatic disease will continue to receive Nivolumab during radiochemotherapy.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Uniklinik RWTH Aachen, Department of Internal Medicine, Aachen, , Germany
Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation, Aachen, , Germany
Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin, Berlin, , Germany
Evangelisches Klinikum Bethel, Children's Hospital, Bielefeld, , Germany
Department of Pediatric Hematology and Oncology, University Hospital, Bonn, , Germany
Children's Hospital, Carl-Thiem Klinikum Cottbus, Cottbus, , Germany
Clinic for Children and Adolescent Medicine, Klinikum Dortmund, Dortmund, , Germany
Department of Internal Medicine, Klinikum Dortmund, Dortmund, , Germany
Department of Pediatrics, University Hospital, Technische Universität Dresden, Dresden, , Germany
Department fo Radiotherapy, University Hospital, Erlangen, , Germany
Department of Pediatrics, University Hospital Erlangen, Erlangen, , Germany
Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, , Germany
Department of Pediatric Hematology and Oncology, University Hospital Essen, Essen, , Germany
Department of Pediatrics, University Hospital, Frankfurt, , Germany
Department of Pediatric Hematology/Oncology, University Hospital Freiburg, Freiburg, , Germany
Department of Pediatric Oncology, Justus-Liebig University of Giessen, Giessen, , Germany
Department of Pediatric Hematology/Oncology, University Medicine Greifswald, Greifswald, , Germany
Department of Pediatric Oncology, University Hospital, Göttingen, , Germany
Universitätsklinikum Halle, Klinik für Pädiatrie I, Halle, , Germany
Department of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf,, Hamburg, , Germany
Department of Pediatric Oncology, University Children's Hospital, Hamburg, , Germany
Department of Otorhinolaryngology, Jena University Hospital, Jena, , Germany
Department of Pediatric Oncology, University Hospital Kiel, Kiel, , Germany
Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Köln, , Germany
Department of Pediatrics, University Hospital Mageburg, Magdeburg, , Germany
Pediatric Hematology/Oncology, University Medicine Mainz, Mainz, , Germany
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim,, Mannheim, , Germany
Department of Pediatric Hematology and Oncology, University Children's Hospital, Münster, , Germany
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital, Regensburg, , Germany
Universitätsklinikum Tübingen, Klinik für Pädiatrie I, Tübingen, , Germany
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital, University of Würzburg, Würzburg, , Germany
Contact Details
Name: Udo Kontny, MD
Affiliation: Uniklinik RWTH Aachen
Role: PRINCIPAL_INVESTIGATOR
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