Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

Recruiting now · Phase 2

Conditions studied: Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Neoplasms, Nasopharynx Cancer

In brief

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.

Key facts

Study ID

NCT06019130

Run by

German Society for Pediatric Oncology and Hematology GPOH gGmbH

People needed

57

Starts

2023-01-10

Expected to finish

2028-01-09

Last updated by the study team

2024-05-16

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation

You may not qualify if…

• 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
• Other active malignancy
• 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.
• The subject received an investigational drug within 30 days prior to inclusion into this study
• Subjects who are enrolled in another clinical trial
• Subjects with prior organ allograft or allogenic bone marrow transplantation
• Subjects with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values:
• WBC < 2 000/µl
• Neutrophils < 1 500/µl
• Platelets < 100 x 10e3/µL
• Hemoglobin < 9.0 g/dL
• Creatinine >1.5 x ULN or creatinine clearance < 50 mL/min (using the Cockcroft Gault formula or Schwartz formula in patients < 18 years)
• AST/ALT > 3 x ULN (> 5 x ULN if liver metastases)
• Total Bilirubin > 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 x ULN)
• Hearing loss > 20 dB loss at 3 kHz due to an inner ear disorder and not caused by tumour burden
• History of allergy or hypersensitivity to platinum-containing compounds or other study drug components
• Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
• Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug.

Where it is running

• Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne — Cologne, Germany (enrolling)
• Children's Hospital, Carl-Thiem Klinikum Cottbus — Cottbus, Germany (enrolling)
• Universitätsklinikum Tübingen, Klinik für Pädiatrie I — Tübingen, Germany (enrolling)
• Department of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf, — Hamburg, Germany (enrolling)
• Uniklinik RWTH Aachen, Department of Internal Medicine — Aachen, Germany (enrolling)
• Department fo Radiotherapy, University Hospital — Erlangen, Germany (enrolling)
• Department of Pediatric Oncology, University Children's Hospital — Hamburg, Germany (enrolling)
• Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, — Mannheim, Germany (enrolling)
• Universitätsklinikum Halle, Klinik für Pädiatrie I — Halle, Germany (enrolling)
• Department of Pediatric Oncology, University Hospital Kiel — Kiel, Germany (enrolling)
• Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation — Aachen, Germany
• Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin — Berlin, Germany
• Evangelisches Klinikum Bethel, Children's Hospital — Bielefeld, Germany
• Department of Pediatric Hematology and Oncology, University Hospital — Bonn, Germany
• Clinic for Children and Adolescent Medicine, Klinikum Dortmund — Dortmund, Germany
• Department of Internal Medicine, Klinikum Dortmund — Dortmund, Germany
• Department of Pediatrics, University Hospital, Technische Universität Dresden — Dresden, Germany
• Department of Pediatrics, University Hospital Erlangen — Erlangen, Germany
• Department of Medical Oncology, West German Cancer Center, University Hospital Essen — Essen, Germany
• Department of Pediatric Hematology and Oncology, University Hospital Essen — Essen, Germany
• Department of Pediatric Hematology/Oncology, University Hospital Freiburg — Freiburg im Breisgau, Germany
• Department of Pediatrics, University Hospital — Frankfurt, Germany
• Department of Pediatric Oncology, Justus-Liebig University of Giessen — Giessen, Germany
• Department of Pediatric Oncology, University Hospital — Göttingen, Germany
• Department of Pediatric Hematology/Oncology, University Medicine Greifswald — Greifswald, Germany

Full record on ClinicalTrials.gov

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