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
Additional locations may be listed on ClinicalTrials.gov for NCT03363373.
See trial information on ClinicalTrials.gov for a list of participating sites.
Each patient will receive treatment for up to 101 weeks following the first Naxitamab
administration. 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.
Lead OrganizationY-mAbs Therapeutics
