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BCC018 - A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma


BCC018 - A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

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DiagnosisHigh-risk NeuroblastomaStudy StatusOpen
Age12 Months to 21 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDrug: Naxitamab (Intravenous (IV)) Additionally for patients with ALK aberration: Drug: Ceritinib (Oral)
Last Posted Update2024-03-19 #NCT05489887
International Sponsor
Wake Forest University Health Sciences
Principal Investigators for Canadian Sites
CHU Quebec - Dr.Bruno Michon
CHU Ste Justine - Dr. Pierre Teira
Medical contact
Raoul Santiago
Social worker/patient navigator contact
Isabelle Audet
Clinical research contact
Barbara Desbiens


Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques



Study Description

This is a Phase 2 trial for newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of combining the drug naxitamab with standard induction therapy. Initially, there will be 5 cycles of standard chemotherapy with Naxitamab on days 1, 3 and 5 of each cycle. Patients with an ALK mutation or amplification will have the drug ceritinib added to their treatment regimen as soon as results are available. 

Inclusion Criteria
  • Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma that meets criteria
  • Subjects must be age ≤ 21 years at initial diagnosis
  • Subjects must be >12 months of age at enrollment
  • Subject's bloodwork must be within acceptable study ranges
  • Pregnant subjects are not eligible for this study, a negative serum pregnancy test is required for female participants of childbearing potential
  • Both male and female study subjects who have reached puberty must be willing to use a highly effective contraceptive method, these methods will be discussed with you by the study team
  • All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
  • Subjects enrolled on study must complete all required assessments