A trial comparing nivolumab with bevacizumab for glioblastoma that has come back (CA209143)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Brain (and spinal cord) tumours

Status:

Closed

Phase:

Phase 3

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

Find out how nivolumab affects people with glioblastoma that has come back after surgery, radiotherapy and temozolomide chemotherapy
See how well it works compared to bevacizumab

Who can enter

You may be able to join this trial if all of the following apply

You have a brain tumour called a glioblastoma
Your glioblastoma has come back for the first time after having radiotherapy and chemotherapy
You have satisfactory blood test results
You are able to care for yourself, even if you aren’t able to carry on with all your normal activities (Karnofsky performance status score of 70 or more)
You are at least 18 years old
You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply

Your tumour has grown into the tissue covering your brain (leptomeningeal disease) or has spread outside your skull
You have already had bevacizumab (or a similar drug)
You have already had a drug that works in a similar way to nivolumab (the trial team can advise you about this)
You have had surgery or any other treatment for your glioblastoma in the last 4 weeks, or are likely to need surgery during the time you’ll be on the trial
You have had chemotherapy wafer implants, unless this was the first treatment you had and it was at least 6 months ago
You are taking high doses of steroids on a long term basis, or your dose is being increased
Your scan shows there is some bleeding in your brain, or you’ve had other problems with bleeding or blood clots in the last 6 months
You have high blood pressure that can’t be controlled with medication
You have had a stroke or heart attack in the last 6 months, or have certain other heart problems
You have other problems affecting your central nervous system such as fits (seizures) that aren’t related to your tumour, unless these are controlled with medication
You have an inherited condition that increases your risk of bleeding, or have taken drugs to thin your blood in the last 10 days and the trial doctor thinks this would put you at a high risk of bleeding
You have had an abscess in your brain in the last 6 months
You have a broken bone or a wound that won’t heal
You have an autoimmune disease (there are some exceptions to this that the trial team can advise you about)
You are HIV, hepatitis B or hepatitis C positive
You have (or have had) any other medical condition that the trial team think could affect your taking part
You can’t have an MRI scan for any reason (this could be because you have metal or a pacemaker in your body)
You have had a bad reaction to another monoclonal antibody
You are known to be allergic to the drugs in this trial (or anything they contain)
You are pregnant or breastfeeding

Trial design

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.

People in one group have nivolumab
People in the other group have bevacizumab

CA209143 trial diagram

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.

Hospital visits

You see the trial team and have some tests before starting treatment. The tests include

Physical examination
Heart trace (ECG )
Blood tests
Urine test
MRI scan

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.