Naxitamab and GM-CSF in High Risk Neuroblastoma Patients v6.0
Research type
Research Study
Full title
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.
IRAS ID
235717
Contact name
Juliet Gray
Contact email
Sponsor organisation
Y-mAbs Therapeutics
Eudract number
2017-001829-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Patients will be invited to take part in this study if they have neuroblastoma which has either not responded adequately to treatment or has relapsed in the bones and/or bone marrow. Neuroblastoma is one of the most common childhood cancers and accounts for a high proportion of childhood cancer deaths. The majority of patients have 'high risk' disease, with metastatic bone/bone marrow disease. Outcome in patients who don't respond well to frontline treatment, or who relapse after treatment, is extremely poor.
The purpose of this research is to find out about the treatment effects of an antibody called humanized 3F8 (hu3F8/Naxitamab). In the last decade, antibody therapy has become part of the standard care for children with high risk neuroblastoma. Antibodies are proteins produced by the immune system to fight infections, but can also potentially be used to attack tumour cells.
In order to enhance the positive effect of Naxitamab, the treatment will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Granulocytes are white blood cells that are able to destroy cancer cells and GM-CSF increases the ability of granulocytes to more effectively kill cancer cells. The only treatment that is being tested in this trial is Naxitamab (hu3F8) in combination with GM-CSF, and all enrolled patients will receive both.
Patients can receive treatment for up to 101 weeks following first administration via infusion of Naxitamab- hu3F8 and injections of GM-CSF. Depending on how the participant responds it is up to the treating investigator to decide how many cycles of treatment is required. After treatment has completed, patients will undergo long term follow up of 3 years during which patients will attend visits twice a year to monitor post treatment effects.
This study will take place across 6 countries (UK, Spain, Denmark, United States Canada and Hong Kong.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0565
Date of REC Opinion
2 Jan 2019
REC opinion
Further Information Favourable Opinion