This study investigates the treatment effects of an investigational antibody in children and adults with high-risk neuroblastoma. Neuroblastoma is a type of cancer that forms in certain types of nerve tissue, and high-risk means that the cancer is more likely to come back or spread. The study focuses on patients whose disease did not respond completely to previous treatments or who have cancer in their bones or bone marrow.
Participants will receive treatment for up to 93 weeks with an investigational antibody and a substance that helps stimulate white blood cell growth. The investigational antibody is a humanized monoclonal antibody that targets a specific protein on cancer cells. Participants will be monitored for up to five years after their first dose to assess the treatment's effects.
- Who can participate: Individuals diagnosed with high-risk neuroblastoma, either primary refractory or secondary refractory, are eligible. Participants should have a life expectancy of at least 6 months. Participants who have received recent systemic anti-cancer therapy, have evaluable neuroblastoma outside bone and bone marrow, or have major organ dysfunction are not eligible.
- Study details: Participants will receive an investigational antibody and a growth factor to stimulate white blood cells. The investigational antibody is designed to target cancer cells. An inactive substance that looks like the investigational medicine but does not contain any medicine may be used as a placebo. Participants will be monitored for treatment effects.
