Phase I MiNivAn trial
| Study name | MiNivAn: Phase I study of I-131 MIBG, nivolumab and ch14.18/CHO |
| Study type | Phase I clinical trial |
| Principal investigator(s) | Dr Juliet Gray |
| Institutions | University Hospital Greifswald, University of Wisconsin, University of Southampton, University College London Hospital |
| Partners | Band of Parents, Harvey Hext Trust, J-A-C-K, Solving Kids’ Cancer US |
| Total awarded | $500,000 + £295,277 |
| Solving Kids’ Cancer UK contribution | £255,827 |
Overview
Relapse and refractory neuroblastoma remains a significant challenge, with few options available once a patient has exhausted the standard pathway.
The MiNivAn trial will explore new therapies that can be added in combination to standard anti-GD2 immunotherapy. It will test the combination of I-131 mIBG, an antibody called Nivolumab which promotes cell death, and standard anti-GD2 therapy. This will hopefully create an immunity to neuroblastoma, which is promising for relapsed patients as it works differently to specific chemotherapy drugs.
The ultimate aim is to reduce the number of spots of disease a child has so that they can continue on the standard treatment path to hopefully achieve remission.
Impact
Running this trial in the UK gives an option for families who are facing relapse, and with support from Solving Kids' Cancer UK it is more financially viable than trials abroad. If successful this treatment could move forward to a Phase II and III trial before introduction to the clinic as standard therapy.
Latest update
In May 2024, Solving Kids’ Cancer UK granted additional funding to extend the Phase I MiNivAn clinical trial. The purpose of the extension was to allow additional patients to be recruited to the study in order to improve the validity of the data. With this study being an early phase trial, it is important that researchers are confident in their findings about the effectiveness of the new therapies being investigated.
In addition to this scientific rationale, SKC UK took into consideration the issue of access to trials for families in the UK. The MiNivAn trial is one of few trials available for children with neuroblastoma that has returned after remission (relapse) or has not responded to standard therapies (refractory). By funding this extension, more children will be able to enrol on the study which may be their best option to treat their cancer.
“We are delighted to have been able to extend recruitment to the MINivAN trial," said Dr Juliet Gray. "From the patients who have taken part in the trial so far, we have found the treatment to be generally well tolerated and without any unexpected side effects. We have seen some encouraging responses, but the number of patients who have been treated is small. With the additional recruitment we hope we will have a better understanding of how effective the combination of treatments is, and how best to develop it further. There have been lots of families who have been keen for their children to participate in the trial, and we are very pleased that more children will now have the opportunity to do this."
