Sponsor: Beat Childhood Cancer
Sponsor Study ID: BCC 018
Study Title: A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma
CTO #: 103713
NCT Number: NCT05489887
Phase: II
Protocol Type: Treatment
Age Group: Children
Disease Sites: Brain and Nervous System
Study Objectives: This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. Subjects with an ALK mutation or amplification will have ceritinib added to their treatment regimen as soon as results are available. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.