Klinische Studie
Nivolumab in combination with cisplatin and 5-fluorouracil as induction therapy in children and adults with EBV-positive nasopharyngeal carcinoma(NPC-Nivo)die Kombination von Chemotherapie mit dem Prüfmedikament Nivolumab als Immuntherapeutikum konnte zu einem verbesserten Therapieansprechen führen.
Krankheitsentität(en)
Weitere Solide Tumoren (Kinder und Jugendliche)
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents < 18 years of age
OR
histologically confirmed new diagnosis of EBV-positive
nasopharyngeal carcinoma, WHO stage II or III, in subjects ≥
18 years
2. Stage II or higher (AJCC, 8th edition)
3. Measurable disease by MRI per RECIST 1.1 criteria
4. Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation
Wesentliche Ausschlusskriterien1. Newly diagnosed nasopharyngeal carcinoma, Stage I
2. Recurrent nasopharyngeal carcinoma
3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
4. Prior chemotherapy and/or radiotherapy
5. Other active malignancy
6. 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.
7. The subject received an investigational drug within 30 days prior to inclusion into this study
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgPädiatrische Hämatologie, Onkologie und StammzelltransplantationStudienzentrale0941 94412063spoh(at)ukr.de