A randomised phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed Neuroblastoma - BEACON-Neuroblastoma, a European Innovative Therapies for Children with Cancer (ITCC) - International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN) trial.

TPS10082 Background: Current therapy for relapsed/refractory high-risk neuroblastoma is not evidence based and long-term disease control is poor. Advances in frontline therapy have been achieved through randomised clinical trials. BEACON-Neuroblastoma trial is designed to identify a backbone chemotherapy regimen to be combined with targeted agents and determine if inhibiting angiogenesis with bevacizumab(B) adds to the activity of chemotherapy. It is the first randomized European study for refractory/relapsed neuroblastoma Methods: BEACON-Neuroblastoma is a factorial phase 2, multicentre, international, randomized clinical trial (EudraCT 2012-000072-42, sponsored by the University of Birmingham). Patients 1-21 years with relapsed/refractory high-risk neuroblastoma are randomised to 1 of 4 arms: T (temozolomide), IT (irinotecan-temozolomide), BT (B-T) or BIT (B-IT). The trial tests whether B added to chemotherapy (T or IT) demonstrates activity and whether the addition of I to T increases activity. Primary...