CheckMate CA209-548 in pts with newly diagnosed GBM (MGMT methylated)
Research type
Research Study
Full title
A Randomized Phase 3 Single Blind Study of Temozolomide plus Radiation Therapy combined with Nivolumab or Placebo in Newly Diagnosed Adult Subjects with MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma.
IRAS ID
200086
Contact name
Catherine Mcbain
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2015-004722-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 4 days
Research summary
This is a multicentre, phase 2 non-registrational companion study of radiation therapy and Temozolomide combined with an investigational drug called Nivolumab or placebo in patients with newly diagnosed Methylated MGMT Glioblastoma.
Glioblastoma (GBM) is the most frequent primary brain tumour in adults. Despite first line treatment options of neurosurgery, radiation and temozolomide the average survival time is approximately 12-15 months and nearly all cases recur.
Nivolumab is a new type of study drug which is designed to allow the body's own immune system to recognize cancer cells again and attack them. It is thought to work by blocking a protein on the body's immune cells, tumours are then recognised as foreign and attacked by the immune system.This study is for patients with methylated MGMT status. MGMT is a gene that repairs the naturally occurring mutagenic DNA lesions. Despite the fact patients with MGMT methylated GBM respond better to Temozolomide the prognosis still limited representing a high unmet medical need. Because these patients present some response to Temozolomide it will be included in both treatment arms.
Following a screening period, eligible patients will receive Radiation Therapy (RT) + Temozolomide (TMZ), combined with Nivolumab or placebo.
Patients and doctors will be blinded to what medication they have been assigned to. Nivolumab or placebo will be given intravenously (through vein). Patients will undergo: surgical tumour biopsy if required, an MRI, physical, vital signs, oxygen levels and bloods for routine safety testing and study specific testing. Patients can remain on the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. At the conclusion of the study, patients who continue to gain clinical benefit may be eligible to continue to receive study drug. Globally 320 subjects will participate in this study.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0196
Date of REC Opinion
29 Mar 2016
REC opinion
Favourable Opinion