A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma

Summary

Neuroblastoma, the most common solid tumor found outside the skull in children, accounts for 7–10% of all childhood cancers. For children over 18 months of age, a diagnosis of metastatic neuroblastoma is more difficult to treat, and even with current standard therapies, there is a significant risk of relapse. When relapse occurs, treatment becomes more challenging, and overall survival rates are lower. Because of this, there is a critical need for more effective therapies that can help children achieve and stay in remission, improving outcomes and offering families more hope for the future.

Objectives

This multicenter clinical trial is studying the safety and efficacy of the monoclonal antibody naxitamab, combined with standard induction treatment, in children newly diagnosed with high-risk neuroblastoma.

Eligibility criteria

In addition to criteria that could prevent participation, there are criteria participants must meet including but not limited to the following:

• Must have a verified diagnosis of neuroblastoma or ganglioneuroblastoma (Must meet disease stage–specific eligibility criteria at time of diagnosis)
• Must be ≤ 21 years old at initial diagnosis
• Must be > 12 months of age at enrollment
• Must not have known contraindications to Peripheral Blood Stem Cell collection
• Must have protocol-defined adequate organ function
• A negative serum (blood) pregnancy test is required for female participants of childbearing potential (≥ 13 years old or after onset of menses)
• Both male and female post-pubertal study subjects must be willing to use a highly effective contraceptive method from the time of informed consent until 6 months after study treatment discontinuation
• Must not be breastfeeding, and breast milk cannot be stored for future use while the mother is being treated on the study.
• Must not be receiving any other investigational drug while on this study
• Must not have any other medical condition that is deemed by the Investigator to be likely to interfere with the interpretation of the results or ability to cooperate and participate on the study.
• Subjects with an ongoing serious medical problem unrelated to cancer or its treatment that is expected to interfere with the action of the investigational medicinal product or to significantly increase the severity of toxicities experienced from trial treatment will not be able to participate.

Clinicaltrials.gov Study Details >