
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is for people who have had surgery, chemotherapy and radiotherapy for bladder cancer that has grown into the muscle wall. This is called muscle invasive bladder cancer.
Cancer Research UK supports this trial.
Surgery, chemotherapy and radiotherapy are usual treatments options for muscle invasive bladder cancer.
After treatment you have follow up appointments every few months. These are to check how you are and see whether you have any problems or worries.
You might also have tests including blood tests, a and scans. But you don’t usually have more treatment unless your cancer comes back.
Researchers are looking for treatments that might slow or stop cancer growth. In this trial they are looking at a drug called durvalumab. It is a type of immunotherapy. It stimulates the body's to fight cancer cells.
Researchers aren’t sure how well it will work so they want to find out more.
Some people in this trial have durvalumab. And some don’t. They have follow up appointments with their doctor as usual.
The main aims of the trial are to:
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:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You can’t take part if:
Other
You can’t take part if:
This is a phase 2 trial. It is taking place in Canada and Europe.
The researchers need 190 people to take part including 50 people from the UK.
It is a randomised trial. You are put into a group by a computer. There are 2 groups. Neither you nor your doctor will be able to decide which group you are in.
You have 1 of the following:
Observation group
You don’t have treatment if you are in this group. You see the trial doctor every 4 weeks for a check up. You have these for up to 1 year.
Durvalumab group
You have durvalumab as a drip into a vein. You have it once every 4 weeks. It takes about 60 minutes each time. You have treatment for up to 1 year as long as treatment is working and the side effects aren’t too bad.
You stop durvalumab if your cancer comes back or gets worse.
For both groups the doctor talks to you about treatment options if this happens.
Quality of life
The study team asks you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Blood tests
You have extra blood tests as part of this trial. Researchers are looking for:
Urine tests
You have extra urine tests to look for .
Tissue samples
The trial team asks to use a tissue sample your doctor took when you had surgery or a biopsy. They also look at the samples you give when you have a test to look inside the bladder (cystoscopy).
Researchers want to look for certain proteins (biomarkers) in the cancer.
You see a doctor and have some tests before you can take part. These include:
You have durvalumab at the hospital.
Everyone sees the doctor once a month for a check up for up to 1 year.
You see the team 1 month after you stop treatment or finish observation.
You have a test to look inside your bladder (a cystoscopy) and the doctor takes a sample of tissue during this test. You have this test every:
You would have these tests as part of your routine care if you weren’t in the trial.
You have a CT scan or PET-CT scan at:
And then every 3 months in the second year. The team can tell you how often you have them after that.
Follow up
As well as the appointments for tests after treatment or when you finish the observation part of the trial you see the team for a check up. These are:
After that the team may phone you to see how you are getting on or see you at a routine hospital visit.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Durvalumab can affect the immune system. It 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. Rarely, these side effects could be life threatening.
If you have any of these side effects you should tell the doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.
The common side effects of durvalumab include:
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Simon Crabb
AstraZeneca
Cancer Research UK
University Hospital Southampton NHS Foundation Trust
Canadian Cancer Trials Group (CCTG)
This is Cancer Research UK trial number CRUKE/18/013.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.