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)
Kopf-Hals Bereich
StudientypInterventionsstudiePhase II
Kopf-Hals Bereich
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