Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

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.

Trial Details

NCT ID

NCT06019130

Phase

PHASE2

Sponsor

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Status

RECRUITING

Cancer Type

Nasopharyngeal Head and Neck Cancer

Interventions

Nivolumab
Cisplatin
5-Fluorouracil
Gemcitabine
Radiotherapy
Interferon beta-1a

Locations (sample)

Aachen, Germany|50.77664,6.08342
Aachen, Germany|50.77664,6.08342
Berlin, Germany|52.52437,13.41053
Bielefeld, Germany|52.03333,8.53333
Bonn, Germany|50.73438,7.09549

Key Eligibility Criteria

Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged be…
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…

For full eligibility, visit ClinicalTrials.gov.

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