BEACON2
Research type
Research Study
Full title
BEACON2 - A Multi-Arm, Multi-Stage Platform Trial For Relapsed Neuroblastoma
IRAS ID
1006346
Contact name
Lucas Moreno Martin Retortillo
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2022-003816-10
ISRCTN Number
ISRCTN12532102
Research summary
Despite advances with the introduction of anti-GD2 immunotherapy, there is a major unmet need to develop new drugs for treatment of high-risk neuroblastoma. Around half of patients relapse despite intensive therapies, and outcome following relapse is dismal (<10% long term survival). Combining chemotherapy with immunotherapy has been the most significant advance in relapsed therapy but implementing this into clinical practice faces numerous challenges and is still largely unavailable across Europe.
The BEACON trial successfully identified two novel regimens including bevacizumab and dinutuximab beta. The phase 2 data generated needs to be expanded and confirmed in order to change practice. European neuroblastoma experts from international specialist organisations and patient advocacy groups strongly support the need to develop a new platform trial focused on relapsed neuroblastoma. Building on the results of BEACON, BEACON2 will test which chemotherapy combination demonstrates the best efficacy in relapsed neuroblastoma by evaluating the safety of the regimens, anti-tumour response, longer term outcome and quality of life, in order to identify novel combinations that further improve survival in this patient group.
Based on our experience in running BEACON, the BEACON2 platform will focus on relapse patients, retaining the ability to compare multiple arms and will have two tiers (Tier 1, a first relapse randomisation and Tier 2, to facilitate smaller dose confirmation expansion cohorts of novel regimens) to be most efficient. The large network of international sites will facilitate rapid recruitment and widen access to novel drugs globally.
The study is funded by international charity Fight Kids Cancer. It will recruit from hospitals through the UK, Europe and Australasia.REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0412
Date of REC Opinion
19 Jun 2024
REC opinion
Further Information Favourable Opinion