ANBL2131: A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma
ANBL2131
What is the goal of the study?
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. Poor responders evaluated at the end of Induction (EOI), who initially receive chemotherapy only, will receive an Extended Induction regimen with chemoimmunotherapy. Poor responders who initially receive chemoimmunotherapy may also receive an Extended Induction regimen. All patients treated on both arms of the study who achieve a good end of Induction response (GEIR) and patients who achieve a subsequent GEIR following Extended Induction will receive Consolidation (tandem transplant and focal external beam radiation) and Post-Consolidation therapy (dinutuximab/sargramostim immunotherapy and isotretinoin). The primary endpoint is EFS. Approximately up to 478 eligible and evaluable patients are anticipated to enroll over approximately 3.2 years. Key secondary endpoints include assessment of toxicity, end of Induction response, outcomes following Extended Induction, and overall survival. Embedded correlative studies seek to evaluate biomarkers of response and resistance to chemoimmunotherapy, changes in tumor and host factors related to therapy, and the effect of telomere maintenance mechanisms on outcomes.
Who can participate in the study?
Please contact the study team listed below to learn more.