This is a single-arm, multicenter clinical trial conducted in patients ≥ 12 months of age with high-risk neuroblastoma in first complete response. 62 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin.
In line with post-consolidation maintenance treatment of high-risk neuroblastoma, this trial will include patients with high-risk neuroblastoma in first complete response. Patients must have completed a multimodal frontline regimen (induction and consolidation) and have achieved complete response (positive bone marrow minimal residual disease as assessed by RTqPCR is allowed) following the multi agent induction and consolidation therapy.
histopathology of solid tumor biopsy, or
BM aspirate or biopsy indicative of NB plus high blood or urine catecholamine metabolite levels
MYCN-amplified at stage L2, M or MS (according to International Neuroblastoma Risk Group (INRG)) of any age or
MYCN-nonamplified with stage M (according to INRG) and diagnosed at ≥ 18 months of age or
Verified PD during induction or consolidation therapy
Any systemic anti-cancer therapy, including chemotherapy, within 3 weeks prior to enrollment
ASCT within 6 weeks prior to enrollment or ongoing toxicity caused by the ASCT at the discretion of the Investigator
Therapeutic 131I-MIBG within 6 weeks prior to enrollment
Single group
Naxitamab
DrugNaxitamab + GM-CSF: Cycles 1-5: Patients will receive naxitamab IV at 3 mg/kg/infusion on Day 1, 3 and 5 and GM-CSF sc at 5 µg/kg/day on Days -4 to 0 and at 10 µg/kg/day on Days 1-5 for 5 cycles. Isotretinoin: Cycles 3-8: Patients will receive isotretinoin PO at 160 mg/m2/day divided into two daily doses on Days 15-28 for 6 cycles.
2-year progression free survival
2-year progression free survival defined as the proportion of patients alive and without progressive disease or relapse 2 years after enrollment
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