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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03363373.
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
