Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Titre officiel

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

Sommaire:

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 93 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Description de l'essai

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)
  • Number of infusions done in an outpatient setting
  • Percentage of infusions done in an outpatient setting
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. Treatment cycles are repeated every 4 weeks (±1 week) until complete response or partial response followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. End of treatment will take place around 8 weeks after the last cycle and thereafter long-term follow-up will continue.

Voir cet essai sur ClinicalTrials.gov

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