OncoMatch

OncoMatch/Clinical Trials/NCT06019130

Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

Is NCT06019130 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for nasopharyngeal carcinoma.

Phase 2RecruitingGerman Society for Pediatric Oncology and Hematology GPOH gGmbHNCT06019130Data as of Jun 2026Location: Germany

Treatment: Nivolumab · Cisplatin · 5-Fluorouracil · Gemcitabine · Interferon beta-1aThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Nivolumab

Chemotherapy

Cisplatin5-FluorouracilGemcitabine

Other

Interferon beta-1a

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)

Demographics

Ages ≥ 3

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT06019130 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require EBV?

Yes, EBV positive is a required biomarker for enrollment.

Does this trial require CD274?

Yes, CD274 testing required is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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