At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of neuroblastoma per International Neuroblastoma Response Criteria
- ✓High-risk disease with primary refractory disease or incomplete response to salvage treatment (includes stable disease, minor response, partial response)
- ✓Evaluable disease in bone and/or bone marrow
- ✓Life expectancy ≥6 months
- ✕Any systemic anti-cancer therapy (chemotherapy or immunotherapy) within 3 weeks prior to first dose
- ✕Evaluable neuroblastoma outside bone and bone marrow
- ✕Major organ dysfunction >Grade 2 (except hearing loss, hematological status, kidney and liver function)
- ✕Active life-threatening infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GM-CSF + Naxitamab for Neuroblastoma. Active but no longer recruiting, targeting 122 participants across 20 sites in 9 countries.
Signals
Detailed 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
Study Details
Timeline
Interventions
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody