Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma

Prior treatment

• Current use of a prohibited medication or requires any of these medications during the study:
  • Treatment with corticosteroids is not allowed within 2 weeks prior to the first block of chemotherapy and until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
  • Vaccinations (including seasonal influenza) are not allowed during administration of dinutuximab beta and until 10 weeks after last treatment course.
  • Concomitant use of intravenous (IV) immunoglobulins is not allowed.
  • Concomitant use of cardioprotectant dexrazoxane is not allowed.
• Major surgery within 21 days prior to the first treatment dose

Other illness

• Previous cancer-specific treatment for neuroblastoma.
• History or documented evidence of severe acute or chronic infection or infectious illness requiring parenteral therapy unless fully healed
• Have a known immediate or delayed hypersensitivity reaction to study drugs

Lab values

• Any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug

Other

• Pregnancy or positive pregnancy test in females of childbearing potential.
• Breast feeding.
• Sexually active participants not willing to use highly effective contraceptive method
• Patients with spinal cord involvement

• Established diagnosis of neuroblastoma Stage M, according to the SIOPEN modified International Neuroblastoma Risk Group (INRG) and to the INSS criteria (Appendix 1).
• Age ≥18 months and \<18 years.
• Body weight \>12 kg.
• Alanine transaminase and aspartate aminotransferase \<10 × upper limit of normal (ULN), total bilirubin \<1.5 × ULN based on age specific reference ranges.
• Calculated glomerular filtration rate \> 60 mL/min/1.73 m2 or serum creatinine \<1.5 × ULN corrected for age.
• Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) \>50% as determined by echocardiography or MUGA.
• Able to comply with scheduled follow-up and study procedures.
• Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national law and legislation.