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| Diagnosis | Neuroblastoma | Study Status | Open |
| Phase | II |
| Age | Child, Adult, Older Adult - (1 Year and older) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | naxitamab (intravenous); GM-CSF (sub-cutaneous) |
| Last Posted Update | 2024-01-19 |
| ClinicalTrials.gov # | NCT03363373 |
International Sponsor
Y-mAbs TherapeuticsPrincipal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel MorgensternCentres
Study Description
This is a study of naxitamab, also known as hu3F8, a humanised antibody targeting GD2 in children and adults diagnosed with high-risk neuroblastoma. GD2 is a marker present at the surface of the neuroblastoma cells; therefore the naxitamab can target the neuroblastoma cells and stimulate the immune system to kill them.
Patients with with primary refractory disease (disease that has never improved with previous treatment), or patients that have had a relapse but incomplete response of the disease in bone and/or bone marrow from salvage treatment will be considered for this study.
Granulocyte-macrophage colony stimulating factor (GM-CSF) will be given along naxitamab.
Inclusion Criteria
- Diagnosis of high-risk neuroblastoma with disease in bone and/or bone marrow.
- High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
