A trial of ipilimumab and temozolomide for people with glioblastoma (Ipi-Glio)

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 2

This trial is for people with a type of brain tumour called glioblastoma. It is for people who have had treatment with:

surgery
then radiotherapy with temozolomide

More about this trial

Glioblastoma is one of the most common types of brain tumours in adults. The usual treatment for people with a newly diagnosed glioblastoma is:

surgery to remove some or all of the tumour
radiotherapy with temozolomide (this is called chemoradiotherapy)
then temozolomide alone for up to 6 months (this is the adjuvant treatment)

But glioblastomas can come back or continue to grow despite the usual treatment. In this trial, doctors want to find out whether ipilimumab can help to stop glioblastomas from coming back.

Ipilimumab (also called by its brand name Yervoy) is a type of targeted drug called a monoclonal antibody. It works by stimulating certain immune cells called T-cells to find and attack the cancer. Ipilimumab is already a possible treatment for people with advanced melanoma.

Everyone taking part in this trial has surgery and 6 weeks of chemoradiotherapy. They then have one of the following adjuvant treatments:

temozolomide (the usual treatment)
temozolomide and ipilimumab

The main aim of this trial is to find out whether adding ipilimumab to the usual treatment helps people with glioblastoma.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

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

you have a newly diagnosed glioblastoma
you had brain surgery and doctors removed at least a fifth of the tumour (your doctor can tell you more about this)
you started radiotherapy within 49 days (about 1 and 1/2 months) after surgery
have completed standard radiotherapy and temozolomide (chemoradiotherapy)
doctors think that temozolomide is a suitable treatment for you
you are between 18 and 70 years old
you have satisfactory blood test results
you are well enough to carry out all your normal activities apart from heavy physical work (performance status 0 or 1)
you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any possibility that you or your partner could become pregnant

Who can’t take part

You cannot join this trial if any of these apply:

Cancer related

you have a type of glioblastoma called multifocal (your doctor can tell you more about this)
you had a low grade astrocytoma that turned into a glioblastoma (a secondary glioblastoma)
your glioblastoma has spread outside the brain or to the membranes that cover the brain (carcinomatous meningitis)
you have had any treatment apart from surgery and 6 weeks of radiotherapy with temozolomide (chemoradiotherapy)
you take a high dose of dexamethasone (more than 3mg every day)
you have a significant bleeding in or around the glioblastoma
you have had another active cancer apart from non melanoma skin cancer or an early cancer (carcinoma in situ ) of the cervix that has been successfully treated

Medical conditions

You cannot join this trial if any of these apply. You:

have an autoimmune disease that doctors think could affect you taking part in this trial
have lung problems such as scarring of the lungs (fibrosis)
take, or have taken drugs that damp down your immune system unless it was a cream, inhaler or a very small dose
have problems with your digestive system that doctors think could affect you taking part in this trial
had a severe infection in the past month
are taking part in another clinical trial or have taken part in a trial in the past 4 weeks that looked at a new treatment (interventional trial)
have HIV
have hepatitis B or hepatitis C
have any other serious condition or mental health problem that the trial team think could affect you taking part

Other

You cannot join this trial if any of these apply. You:

are pregnant or breastfeeding
are sensitive to the drugs used in this trial or any other similar drug

Trial design

This is a phase 2 trial. Researchers hope that around 120 people from the UK will agree to take part.

Everyone has surgery to remove all or part of the tumour. And standard radiotherapy with temozolomide (chemoradiotherapy). This is the same as the usual treatment. Your doctor can tell you more about this.

You start this trial after finishing chemoradiotherapy.

This is a randomised trial. The people taking part are put into 1 of the following groups at random:

temozolomide and ipilimumab (arm A)
temozolomide (arm B)

Neither you nor your doctor are able to decide which group you are in. You are 2 times more likely to have temozolomide and ipilimumab than temozolomide alone.

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Temozolomide and ipilimumab (Arm A)

You start ipilimumab within 2 weeks of finishing chemoradiotherapy.

You have ipilimumab as a drip into your bloodstream every 3 weeks. You can have up to 4 ipilimumab treatments. It takes about one and a half hours each time you have it.

You also take temozolomide tablets. You start temozolomide a month after finishing chemoradiotherapy.

You have temozolomide in cycles of treatment. Each cycle lasts 28 days. You can have up to 6 cycles of treatment, taking about 6 months in total.

You have each cycle of temozolomide in the following way. You:

take temozolomide as tablets that you swallow whole every day for 5 days
then have a break of 23 days

Temozolomide (Arm B)

You start temozolomide a month after finishing chemoradiotherapy.

You have up to 6 treatment cycles of temozolomide. Each cycle lasts 28 days. You have each cycle in the following way. You:

take temozolomide tablets every day for 5 days
then have a break of 23 days

You then start the next cycle of treatment.

Diary card

The trial team will ask you to complete a diary card. You have a new diary card for each temozolomide treatment cycle. You fill it in every day you take temozolomide and each time you take other drugs such as steroids.

You return the diary card to the trial team when you finish each treatment cycle.

Blood tests

You have some extra blood tests as part of this trial. You have them before the start of treatment and at set times during the trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination
blood tests
urine test (for pregnancy)

During treatment, you see the trial team every 4 weeks if you join the temozolomide group (arm B). You see the trial team more regularly if you join the temozolomide and ipilimumab group (arm A).

You have blood tests and a physical examination each time you see the trial team. You may also have a pregnancy test if there is any possibility that you could become pregnant.

You have an MRI scan every 3 months during treatment. This continues for up to 6 months.

When you finish treatment, you see the trial team after 6 weeks. You then see them every month.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment.

Ipilimumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.

The most common side effects of ipilimumab are:

loss of appetite and weight loss
watery poo (diarrhoea) or constipation
feeling or being sick
skin rashes, itching and changes to your skin colour
tiredness (fatigue)
nerve changes that can cause tingling, numbness and weakness in fingers and toes
hair loss or hair thinning
pain at the site of injection
low levels of thyroid hormones that can cause tiredness, weight gain and feeling cold
loss of fluid in your body (dehydration)
confusion, dizziness and headaches
problems in your eyes such as blurred vision and pain
low blood pressure and a fast heart rate
sweating
shortness of breath and cough
bleeding and inflammation of your stomach and bowel
heartburn or indigestion
pain in your muscles and joints
flu like symptoms and high temperature (fever)
changes to the way your liver works