CA209-498: Newly Diagnosed Glioblastoma (MGMT unmethylated)

• Research type

  Research Study

• Full title

  A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma

• IRAS ID

  194818

• Contact name

  Valerie Perpette

• Contact email

  eusu@ bms.com

• Sponsor organisation

  Bristol Myers Squibb International Corportation

• Eudract number

  2015-003739-37

• Clinicaltrials.gov Identifier

  NCT02617589

• Duration of Study in the UK

  2 years, 11 months, 12 days

• Research summary

  This is a multicentre, phase 3 study involving an investigational drug called Nivolumab vs Temozolomide each in combination with radiation therapy in patients with newly diagnosed Unmethylated MGMT Glioblastoma.
  Glioblastoma (GBM) is the most frequent primary malignant 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 stimulate the body's own immune system to help attack cancer cells. 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 unmethylated MGMT status. MGMT is a gene that repairs the naturally occurring mutagenic DNA lesions. The rationale for selecting unmethylated MGMT patients is that they represent the GBM population with the highest unmet medical need. These patients are less responsive to temozolomide and have a worse prognosis compared to patients with methylated MGMT tumours.

  Following a screening period, eligible patients will either receive Nivolumab + Radiation Therapy (RT) or Temozolomide + RT.
  Patients and doctors will know what medication they have been assigned to. Nivolumab is given intravenously (through vein) whereas Temozolomide is given as capsules. 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 550 subjects will participate in this study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0034

• Date of REC Opinion

  12 Feb 2016

• REC opinion

  Further Information Favourable Opinion