A Phase I study of 131-1 mIBG followed by Nivolumab and Dinutuximab beta Antibody in children with relapsed/refractory Neuroblastoma. (The MINIVAN trial)
Chief Investigator: Dr Juliet Gray
This is a phase I trial investigating combining 131-I mIBG therapy, anti-PD-1 antibody (Nivolumab) and anti-GD2 antibody (dinutuximab beta) in children with relapsed or refractory neuroblastoma.
The study is jointly funded by the charities Solving Kids Cancer (UK and US), Joining against Cancer in Kids (J.A.C.K) and Band of Parents, through the INBRACED initiative. It is a collaborative transatlantic study, led by Dr Juliet Gray and Dr Mark Gaze (UK), Professor Paul Sondel and Dr Ken Desantes (Madison, US) and Professor Holger Lode (Greiswald, Germany).
The study is based on pre-clinical (laboratory) results suggesting that this combination of treatments work effectively together to kill neuroblastoma and generate immunity to the tumour. Although each of the treatments has been widely used in children, they have not previously been used in combination. The study is designed primarily at the side effects and tolerability of this new combination of treatments in children with neuroblastoma, but is also looking for evidence that this treatment is effective at treating neuroblastoma and also to investigate the immune effects.
The study has 3 cohorts (groups) of patients. The first cohort of patients only received 131-I mIBG therapy and Nivolumab. This was well tolerated with no unexpected side effects, so the second cohort of patients are now receiving 131-I mIBG therapy, Nivolumab and a 50% dose of dinutuximab beta. If the patients in cohort two, tolerated this treatment well, then a final, third cohort of patients will receive all three treatments at the full dose.
The trial is open to most patients with relapsed or refractory neuroblastoma who have MIBG positive disease on scans. For more details about specific eligibility criteria, please see:
The study opened in the UK (Southampton Children’s Hospital and UCLH London) in July 2018, and in the US (Madison Children’s Hospital) in September 2020. It is hoped it will open in Greifswald in Germany very soon.
For more details about the study, please contact Dr Juliet Gray (jcgray@soton.ac.uk) or see: https://www.solvingkidscancer.org.uk/minivan.
