
"He went through six operations and was placed on a clinical trial so he could try new treatments.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the drugs nivolumab (pronounced niv-ol-yoo-mab) and bevacizumab (pronounced bev-a-siz-oo-mab) for a type of brain tumour called a glioblastoma.
Doctors usually treat glioblastoma with surgery followed by radiotherapy and the chemotherapy drug temozolomide.
But a glioblastoma can come back after treatment and researchers are looking for ways to help people when that happens. In this trial they are looking at 2 drugs called nivolumab and bevacizumab.
Nivolumab is a drug called a monoclonal antibody. It works by blocking a body substance called PD-1. This may help the body’s immune system to work against brain cancer cells.
This trial is comparing nivolumab with another monoclonal antibody called bevacizumab which is already used as treatment for glioblastoma in some countries (but not routinely in the UK).
The aims of the study are to
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply
This is an international phase 3 trial. The researchers need about 220 people to join. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Whichever group you are in, you have treatment once every 2 weeks through a drip into a vein. If you have nivolumab, it takes about an hour each time. If you have bevacizumab, it takes 1½ hours the first time. From then on, it will take half an hour or an hour each time.
As long as you don’t have bad side effects, you can carry on having the treatment for as long as it helps you.
You see the trial team and have some tests before starting treatment. The tests include
To take part in this trial, the researchers need a sample of tissue from your brain tumour. They will try to get a sample of the tissue that was removed when you had surgery. But if there isn’t a sample available, they will ask you to have a biopsy.
You go to hospital every 2 weeks to see the trial team and have your treatment. You have regular blood tests and heart traces. You have an MRI scan after 6 weeks, 12 weeks and then every 8 weeks until you stop having treatment.
The trial team will ask you to fill out a questionnaire before you start treatment and each time you have an MRI scan. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
When you finish the treatment, you see the trial team again a month later and then about 2 ½ months after that. If you are in the group having nivolumab, the trial team will take some extra blood samples to see how it has affected your immune system.
The trial team will then phone you once every 3 months to see how you are. They may ask you to have more MRI scans.
If you stop having treatment for any reason other than your tumour getting worse, the trial team will ask you to carry on having MRI scans as described above, until your tumour does start to get worse, or you start another treatment, or choose not to do this any longer.
As nivolumab is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have been
The most common side effects of bevacizumab include
We have more information about the side effects of bevacizumab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Catherine McBain
Bristol-Myers Squibb
Freephone 0808 800 4040
"He went through six operations and was placed on a clinical trial so he could try new treatments.”