Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3+
SponsorGerman Society for Pediatric Oncology and Hematology GPOH gGmbH
About this trial
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.
Eligibility criteria
Qualifiers
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
Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients > 25 years of age (AJCC, 8th edition)
Measurable disease by MRI per RECIST 1.1 criteria
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
Disqualifiers
Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients > 25 years of age
Recurrent nasopharyngeal carcinoma
Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
Prior chemotherapy and/or radiotherapy
Trial design
Treatments tested in this trial
- Nivolumab
- Cisplatin
- 5-Fluorouracil
- Gemcitabine
- Radiotherapy
- Interferon beta-1a
- MRI
- PET
- Patient-Reported Outcomes
Treatment groups
57 Participants
are divided into 5 treatment groupsSponsors and collaborators
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Lead sponsor
RWTH Aachen University
Sponsor institution
Deutsche Krebshilfe e.V., Bonn (Germany)
Collaborator
Source ClinicalTrials.gov