Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma

Neuroblastoma (NB)Documented high-risk disease Receipt of Standard of Care (SoC) frontline induction/consolidation therapy (including surgery, chemotherapy, ASCT, MIBG, radiotherapy, immunotherapy, or retinoids)

Active disease despite previous aggressive multi-drug chemotherapy, defined as one of the following:

verified first progression during multi-drug frontline treatment orverified first episode of relapse, defined as recurrence after response to frontline treatment, or verified first designation of refractory disease, defined as persistent metastatic disease (SD or minor response by INRC and MIBG curie score ≥3) detected at conclusion of at least 4 cycles of multi-drug induction chemotherapy on or according to a high-risk NB treatment protocol as defined above

The patients must have one of the following (locally assessed) obtained within 3 weeks prior to enrollment and at least 10 calendar days after end of any prior anti-cancer treatment:

Measurable tumor on CT/MRI scan that is MIBG-avid or demonstrates increased FDG uptake on PET scanMIBG (Metaiodobenzylguanidine) scan with positive uptake at a minimum of one site. This site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction Age ≥ 12 months at enrollment Written informed consent