A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma

Sponsor:

Beat Childhood Cancer

Sponsor Study ID:

BCC018

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.

eConsent:

Not available

Study Documents:

Open Study Documents
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