A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma - BEACON 2
Chief Investigator: Lucas Moreno
Sponsor: University of Birmingham, United Kingdom
Funders/Charity: Fight Kids Cancer
BEACON2 is a platform multi-arm multi-stage (MAMS) randomised phase I/phase II, open-label, international trial for participants with relapsed neuroblastoma.
The trial will comprise two tiers.
Tier 1 (phase II) will be the main randomisation and will initially focus on comparing the efficacy and safety of 2 arms.
Arm A: dinutuximab beta added to a chemotherapy regimen comprising of irinotecan and temozolomide.
Arm B: bevacizumab added to a chemotherapy regimen comprising of irinotecan and temozolomide.
Tier 2 (phase I) will include a dose expansion/confirmation cohort which will explore the potential additive effects of combining bevacizumab AND dinutuximab beta to a chemotherapy backbone, before being introduced into Tier 1 if appropriate. Using the rolling MAMS design will allow the introduction of novel agents or regimens as new arms, if appropriate.
All patients enrolled in the trial must have relapsed Neuroblastoma
The study is estimated to open in July 2024 in UK and aims to recruit 160 patients. A total of 79 sites are planned to be open.
