UK Clinical Trials

There are numerous DIPG trials available worldwide (subject to eligibility criteria) currently however there is only limited scope in the UK for open trial options available on the NHS.

Presently there are only TWO recruiting trials for DIPG in the UK 

1) Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication (BIOMEDE)    

2) The Bristol-Myers Squibb sponsored 'Checkmate 908' -    'An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies'

Check the availability and eligibility criteria for 'Checkmate 908' here ...https://clinicaltrials.gov/ct2/show/NCT03130959 

BIOMEDE

Abbie's Army are connected to the 'BIOMEDE' trial established in 2017, it is a 'Phase 2'  and currently available for newly diagnosed DIPG patients only (prior to radiation) available in numerous UK specialist cancer centers this is part of a wider highly structured European roll out.

This is the trial identification number... https://clinicaltrials.gov/ct2/show/NCT02233049 

The Principal Investigator in the UK is Dr Darren Hargrave at Great Ormond Street Hospital. Please consult your individual treating oncologist for advice regarding eligibility for this trial which includes biopsy.

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

BIOMEDE is the first upfront ‘stratified’ clinical trial for DIPG children in the UK, patients are first separated dependent on their molecular ‘expression’ to receive one of three agents.

With the majority of patients receiving a treatment assumed to specifically target a biological abnormality identified on the biopsy, more importantly patients will not receive a drug for which the identified target is absent.

In this first step of the protocol, the patients will thus be allocated to one of the three treatment groups as follows:

  • If the tumour overexpresses EGFR without PTEN loss of expression, patients may receive erlotinib or dasatinib allocated by randomization (R1 randomisation).
  • If the tumour shows loss of PTEN expression without EGFR overexpression, patients may receive everolimus or dasatinib allocated by randomisation (R2 randomisation).
  • If the tumour shows both EGFR overexpression and loss of PTEN expression, patients may receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).
  • If the tumour shows neither EGFR overexpression nor loss of PTEN expression (a very rare situation in our experience), patients will receive dasatinib (no randomisation).
  • If the biopsy assessment is not contributive, the treatment will be allocated by randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).

A key feature of  BIOMEDE however is that experimental agents  can be introduced if molecular analysis identifies other present ‘targets’ after interim review (or at relapse) 

There is an initiative to develop novel ‘patient-driven’ models of human DIPG disease  that can be tested and possibly transfer effective combinations back to the patient during therapy. In conjunction with this UK trial and Prof Chris Jones 'Abbies Army' are working with The Institute of Cancer Research to provide 'PDX' 'avatar' models for this much broader analysis in the hope of exposing additional targets for therapy during the course of patient disease.

Crucially data will be fed back to treating clinicians and  help build a more conclusive picture of consistently effective combination therapies, as well as validate the use of ‘avatar’ models in future trial designs.

Most importantly for anyone included in the BIOMEDE trial we will have full characterisation of their tumours.