A trial looking at IMA950 vaccine and GM-CSF for glioblastoma

Who can enter

You can enter this trial if you

• Have been diagnosed with glioblastoma that can be removed with surgery
• Are going to have standard treatment after surgery
• Have a substance in your blood called HLA-A*02 (just under half the population have this marker in the blood and the trial doctors will ask your permission to test a sample of your blood for it)
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• Have satisfactory blood test results
• Are willing to use a reliable form of contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have a brain tumour that is in your brain stem or cerebellum
• Have already had other treatment for glioblastoma (you can take part if you have started having the standard treatment used in this trial, which is surgery, followed by a combination of radiotherapy and temozolomide, but before starting temozolomide on its own)
• Are taking a high dose of steroids (it is important that you don’t reduce the dose or stop taking steroids without talking to your doctor)
• Have had major surgery in the last 4 weeks apart from the operation to remove your brain tumour
• Have had an experimental drug as part of another clinical trial in the last month
• Have had any sort of vaccination in the last 2 weeks
• Have ever had an autoimmune disease
• Have heart problems that are a cause for concern
• Have an infection that cannot be controlled with medication, or another medical condition that the trial doctors think could affect you taking part
• Are known to be sensitive to GM-CSF
• Are hepatitis B, hepatitis C or HIV positive
• Are pregnant or breastfeeding

Trial design

This is a phase 1 trial. It will recruit about 45 people. Everybody taking part will have standard treatment and injections of IMA950 and GM-CSF.

Standard treatment is surgery, followed by 6 weeks of radiotherapy and a chemotherapy drug called temozolomide. You take temozolomide tablets every day during the 6 weeks of radiotherapy. Having both treatments at the same time is called chemoradiotherapy.

After finishing chemoradiotherapy, you have a break of about 5 weeks. Then you start having temozolomide on its own for 5 days every 4 weeks. Each 4 week period is called a cycle of treatment. You can have up to 6 cycles of treatment.

Some people taking part will start having IMA950 and GM-CSF injections before starting chemoradiotherapy. This group of people are called ‘cohort 1’. Some people will start having the injections after finishing chemoradiotherapy, but before starting temozolomide on its own. They are called ‘cohort 2’.

You have up to 11 injections of IMA950 and GM-CSF over 24 weeks. You have injections

• 3 days in a row during the first week of treatment
• On 1 day in each of the next 3 weeks
• Once more 3 weeks later
• Then 4 more, once every 4 weeks

Each time, you have 2 injections into the skin of your abdomen (tummy) or thigh. These are called ‘intradermal’ injections. You have the GM-CSF first. Then, between 10 and 30 minutes later you have the IMA950.

When you have surgery to remove your brain tumour, a sample of tissue is sent to the laboratory for tests. Any tissue left over is stored safely. The trial team will ask your permission to use some of this tissue to study a gene called MGMT. This may help doctors to learn more about who is most likely to benefit from different treatments for glioblastoma.

You have a number of blood tests during the trial. The trial team will use some of these samples to see how your immune system is responding to the injections.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

• Physical examination
• Blood and urine tests
• Heart trace (ECG)
• MRI scan

The trial team will monitor you closely during the trial. You have regular blood tests, physical examinations and 3 more MRI scans.

You go back to see the trial team 4 weeks after your last injection and again 41 weeks after your surgery.

Side effects

This is the first trial looking at having IMA950 and GM-CSF injections together. In trials of vaccines that are similar to IMA950, side effects have included red skin, itching, swelling or pain at the injection site. But there may be other side effects we don’t know about yet.

The side effects of GM-CSF include

• Bone pain and flu like symptoms
• Feeling tired or weak
• Aching muscles
• Diarrhoea
• Mild fever
• Swelling, redness or discomfort at the injections site

Your study doctor will tell you about other possible side effects, which are less common.

It is possible that you might have an allergic reaction to either IMA950 or GM-CSF. Each time you have injections, the trial team will monitor your pulse, temperature and blood pressure, and watch you closely for any signs of a reaction. They will treat this straight away if it does happen.

There is more information about the side effects of brain tumour radiotherapy and temozolomide on CancerHelp UK.