A randomised phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed Neuroblastoma (The BEACON trial)
Chief Investigator: Dr Lucas Moreno (Vall d’Hebron Hospital, Barcelona, Spain)
Sponsor: University of Birmingham (UK)
This study aims to improve the outcome of children with relapsed or refractory neuroblastoma.
The trial is a collaboration between Innovative Therapies for Children with Cancer (ITCC) and the European Neuroblastoma Research Group (SIOPEN) consortia.
A phase II factorial multi-arm design, evaluating different treatments for children and young adults with relapsed and refractory neuroblastoma. Chemotherapy regimens including temozolomide, irinotecan and topotecan and novel agents bevacizumab and dinutuximab beta were evaluated for safety and activity in the largest randomised trial in this cohort of patients to date.
The study is open to children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma.
The trial opened initially in 2013 to evaluate the role of bevacizumab, irinotecan and topotecan added to temozolomide-based chemotherapy in 160 patients. Bevacizumab, irinotecan and topotecan randomisations have now closed. These results have been presented at ASCO and SIOP meetings in 2019 and 2020:
https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.10001?af=R
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.10501
In 2019, the new dinutuximab beta randomisation was opened planning to recruit 64 patients. 43 sites are participating in BEACON Immuno trial, with 40 currently open for recruitment to the dinutuximab beta randomisation. The trial is now open in the UK, Denmark, Spain, Belgium, Ireland, Switzerland, Austria Netherlands and France. Approvals for Italy are awaited. It is expected that recruitment for this randomisation will be achieved during Q1 2021.
Further details about the trial can be found at clinicaltrials.gov database (NCT02308527): https://clinicaltrials.gov/ct2/show/NCT02308527
