Naxitamab for Neuroblastoma With Osteomedullary Disease

Official Title

A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Summary:

Children and adults diagnosed with high risk neuroblastoma and refractory osteomedullary disease will be treated for up to 93 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Participants will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Trial Description

Primary Outcome:

  • Response rate during Naxitamab treatment
Secondary Outcome:
  • Incidence of adverse events and serious adverse events
  • Duration of Response (DoR)
  • Complete Response Rate
  • Progression Free Survival (PFS)
  • Overall Survival
  • Assessment of the maximum serum concentration (cmax) of naxitamab
  • Assessment of the minimum serum concentration (cmin) of naxitamab
  • Assessment of the clearance of naxitamab
  • Assessment of the volume of distribution of naxitamab
  • Assessment of the Area under the Curve (AUC) of naxitamab
  • Assessment of the terminal half-life (t½) of naxitamab
  • Assessment of human anti-human antibody (HAHA) formation
  • Intravenous (IV) opioid use (cycle 1)
  • Intravenous (IV) opioid use (all cycles)
  • Hospitalization days (cycle 1)
  • Safety of patients with positive human anti-human antibody (HAHA)
Each patient will receive treatment for up to 93 weeks following the first Naxitamab administration and remain in the trial for 101 weeks. After the end of trial visit, each patient will enter a long-term follow-up where they will be monitored for up to 5 years after first treatment cycle. Each investigational cycle is started with 5 days, days -4 to 0, of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5, totalling 9 mg/kg per cycle. The first 5 cycles are repeated every 4 weeks up to week 21 and after that the frequency decreases to every 8 weeks through a total of 93 weeks. End of treatment will take place around 8 weeks after the last cycle and thereafter long-term follow-up will continue.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society