COMBAT-GB
Research type
Research Study
Full title
COMBinATion Nivolumab and ASTX727 (decitabine and cedazuridine) for treatment of primary GlioBlastoma (COMBAT-GB)
IRAS ID
1007984
Contact name
Puneet Plaha
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN30298528
Research summary
Glioblastoma is the most common brain cancer in adults and unfortunately is life limiting. It is most common in older patients with an average age of 55 at diagnosis. However, it can still affect young adults and even children. Currently, there is no cure for this type of brain tumour. Current gold standard treatment consists of having surgery to remove all of the visible tumour followed by chemotherapy and radiotherapy. Survival rates are better for younger patients (aged under 40) but remain generally poor, with 50% of patients only surviving 2 years from diagnosis.
There is a new set of drugs, termed ‘immunotherapies’, that aim to boost the body’s own immune system to fight
cancer. Immunotherapies have been shown to increase survival from certain cancers such as skin cancer and lung cancer. However, these drugs, on their own, do not have much effect on glioblastoma. Our research in Oxford has shown that the addition of an additional drug (“enhancer drug”) to the immunotherapy drug can potentially boost the effect of immunotherapy.
We want to run a phase I safety study to look at the safety of giving a combination of Nivolumab (Immunotherapy drug) and ASTX727 (“enhancer drug”). Phase I studies aim to find the best dose of a new drug with the fewest side effects. Doctors start by giving very low doses of the drug to a few patients. This will be a small trial to establish whether this combination is safe and to look for the best possible dose. Nivolumab has been given to patients in the past with glioblastoma and ASTX727 has been given to patients with leukaemia. This combination has not been tried together before in patients with glioblastoma, so it is important that we conduct this small trial first.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0226
Date of REC Opinion
5 Dec 2023
REC opinion
Further Information Favourable Opinion