A Phase 12 International Trial Testing New Treatment Combinations for Children and Young Adults With Relapsed High-Risk Neuroblastoma

What this Trial Is About

Relapsed neuroblastoma is a common and serious childhood cancer that is difficult to treat, especially in high-risk cases where the disease returns after initial treatment or does not respond to standard therapies. This trial aims to improve survival for children aged 1 year and older with relapsed neuroblastoma by testing new combinations of treatments. It is an international, open-label, randomized phase III study designed to develop and evaluate these new therapies while also studying the biology of the disease using biomarker samples. Participants will be randomly assigned to one of two main treatment groups or enrolled in smaller dose confirmation groups testing new drug combinations. The current main treatments include combinations of dinutuximab beta, irinotecan, temozolomide, and bevacizumab given in 12 cycles every three weeks. Additional experimental groups may receive different combinations of these drugs. The trial includes a translational sub-study collecting tumor, blood, and bone marrow samples to better understand neuroblastoma and improve targeted therapies. During the study, patients will receive their assigned treatments over multiple cycles and be closely monitored for safety, treatment response, and quality of life. Researchers will perform various assessments including imaging scans, laboratory tests, and questionnaires to measure progression-free survival, side effects, and overall clinical benefit. Follow-up will continue up to five years after treatment to assess long-term outcomes and collect further data on patient health and disease progression.

A Multi-Arm, Platform Trial For Relapsed Neuroblastoma