Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
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
Y-mAbs Therapeutics
122 participants
Apr 3, 2018
INTERVENTIONAL
Conditions
Summary
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 101 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
Eligibility
Inclusion Criteria3
- Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
- High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow.
- Life expectancy ≥ 6 months
Exclusion Criteria4
- Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
- Evaluable neuroblastoma outside bone and bone marrow
- Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
- Active life-threatening infection
Interventions
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody
Locations(26)
View Full Details on ClinicalTrials.gov
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NCT03363373