OncoMatch/Clinical Trials/NCT06019130
Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
Is NCT06019130 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for nasopharyngeal carcinoma.
Treatment: Nivolumab · Cisplatin · 5-Fluorouracil · Gemcitabine · Interferon beta-1a — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: EBV positive
histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma
Required: PD-L1 (CD274) testing required (testing required; no eligibility threshold specified)
Sufficient tumor tissue to be sent for central review, including PD-L1 staining
Disease stage
Required: Stage II, III, IV (AJCC, 8th edition)
Excluded: Stage I
Stage II or higher in patients ≤ 25 years, stage III and IV in patients > 25 years (AJCC, 8th edition)
Prior therapy
Cannot have received: chemotherapy
Prior chemotherapy and/or radiotherapy
Cannot have received: radiation therapy
Prior chemotherapy and/or radiotherapy
Cannot have received: anti-PD-1 therapy
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
Cannot have received: anti-PD-L1 therapy
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
Cannot have received: anti-PD-L2 therapy
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
Cannot have received: anti-CTLA-4 therapy
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
Cannot have received: checkpoint inhibitor
any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Lab requirements
Blood counts
WBC < 2 000/µl; Neutrophils < 1 500/µl; Platelets < 100 x 10e3/µL; Hemoglobin < 9.0 g/dL
Kidney function
Creatinine >1.5 x ULN or creatinine clearance < 50 mL/min (using Cockcroft Gault or Schwartz formula in patients < 18 years)
Liver function
AST/ALT > 3 x ULN (> 5 x ULN if liver metastases); Total Bilirubin > 1.5 x ULN (except Gilbert Syndrome ≥ 3.0 x ULN)
Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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