ANBL2131: A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

This randomized study will evaluate the efficacy of a frontline chemoimmunotherapy Induction regimen versus a standard chemotherapy-only Induction regimen that reserves chemoimmunotherapy only for poor responders. This Phase 3 randomized study seeks to determine if the early addition of the anti-GD2 monoclonal antibody, dinutuximab, plus sargramostim, to standard COG Induction improves EFS for patients with newly diagnosed HRNBL. All patients will receive the same Induction Cycle 1 while their tumors undergo centralized molecular testing. Patients will then be randomized to receive either standard Induction or standard Induction with the addition of dinutuximab and sargramostim.

Are you Eligible? (Inclusion Criteria)

• Age at diagnosis: ≤less than or equal to ≤30 years at the time of initial diagnosis with high-risk disease -Patients must have a diagnosis of NBL or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines -Patients must have newly diagnosed HRNBL -Patients must have a BSA ≥ 0.25 m2 -Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI) -Patient must meet all eligibility criteria as outlined in the study protocol.