Our Industry Case Studies

Our industry partnerships are crucial to ensure patients in the UK gain access to innovative treatments at the earliest opportunity. Here are just a few examples of the recent partnerships between our network and industry:

MiNivAn

The Paediatric Network have further strengthened their partnership with Bristol-Myers Squibb, which has allowed it to complete the Phase I study comparing the use of Nivolumab alone with the combination of Nivolumab and Ipilimumab in high-grade CNS tumours.

This has resulted in Bristol-Myers Squibb providing Nivolumab for the novel MiNivAn combination study, which combines the drug with targeted radiotherapy. Funded by Solving Kids Cancer, the trial opened this year at Southampton and UCH, and has recruited patients with relapsed or refractory neuroblastoma from across the UK.

The 2nd and 3rd phases of this international study will add in the antiGD2 monoclonal antibody Dinutuximab beta to the combination (in collaboration with Eusa).

TED14845

This Phase I/II study is testing SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), as both a single agent and in combination with Palbociclib in postmenopausal women with ER positive advanced breast cancer. Funded by Sanofi, the trial’s primary endpoints are to determine safe dosage of SAR439859 in both cases.

Dr Rob Jones of Cardiff ECMC was selected as the UK CI for the trial, which is also being run at other ECMC centres including Oxford and Glasgow. This represents one of a number of other commercial studies which are currently still in setup where Cardiff has been selected as the lead UK site with Rob Jones as UK CI.

CAcTUS - Circulating Tumour DNA Guided Switch (CAcTUS)

This study will be assessing patients longitudinally for ctDNA BRAF mutations, with therapy switched to immune therapy if/when the BRAF mutation level reaches a defined threshold making this the first ctDNA primary end-point validated to Good Clinical Practice for clinical decision making.

This therapy switch design is a pioneering approach to offer patients the correct therapy based on their disease development. Run through the Manchester ECMC, the CAcTUS study is driven by CRUK Manchester Institute, The Christie in collaboration with Bristol-Myers Squibb.

NCT02633800

Dr Martin Forster and Professor Tony Ng, of UCL ECMC, have established collaboration with Daiichi exploring circulating biomarkers in the Phase II study of DS-8201 in patients with advanced HER2-overexpressing or HER2-mutated non-squamous non-small cell lung cancer.

Phase I of this study was conducted at the Clinical Research Facility (PI Dr Forster) and ECMC supported staff (research nurse, studies manager and data manager) were critical to completing the study, which led to the success of this collaboration.

The translational research involved the use of exosome and immune profiling to identify non-invasive treatment stratification and longitudinal monitoring markers in patients with recurrent / metastatic head and neck cancer.

The study found multivariate risk scores/signatures that predicted either progression free survival or RECIST response. The data was presented at ASCO 2018 (along with the Phase II trial data) and manuscripts are currently being written for publication.