Nivolumab or Nivolumab + Ipilimumab vs Bevacizumab in Recurrent GBM
Research type
Research Study
Full title
A Randomized Phase IIB Open Label Study of Nivolumab or Nivolumab in Combination with Ipilimumab versus Bevacizumab in Adult Subjects with Recurrent Glioblastoma(GBM).
IRAS ID
155196
Contact name
Catherine Mcbain
Contact email
Sponsor organisation
Bristol Myers Squibb International Corportation
Eudract number
2013-003738-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov Identifier (NCT number), NCT02017717; ,
Research summary
Research Summary:
This is a multicentre, phase 2 study involving an investigational drug called Nivolumab given alone or in combination
with Ipilimumab vs Bevacizumab in patients with recurrent 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 1215
months and nearly all cases recur. Treatment options for recurrent GBM
are complicated by side effects and limited success. Hence there is an unmet need for a new treatment to improve
clinical outcomes and quality of life for these patients.
Nivolumab is a new type of study drug which is designed to stimulate the body's own immune system to help attack
cancer cells. Ipilimumab is also designed to work using the body’s own immune response via a different pathway.
Both these medications are 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. Bevacizumab is thought to prevent the growth of new blood
vessels that feed tumours .
Following a screening period, eligible patients will either receive Nivolumab, Nivolumab + Ipilimumab or Bevacizumab.
Patients and doctors will know what medication they have been assigned to. All medications are given intravenously
(through your vein). Patients will undergo the following study procedures: 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 240 subjects will participate in this study.Summary of Results:
https://clinicaltrials.gov/study/NCT02017717?tab=results
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0350
Date of REC Opinion
27 Jun 2014
REC opinion
Favourable Opinion