Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of durvalumab after treatment for bladder cancer (BL13)
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.
More about this trial
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
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
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:
- find out if durvalumab can slow cancer growth or delay the cancer coming back
- learn more about the side effects
- find out how treatment affects quality of life
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 urinary bladder cancer that has grown into the muscle wall of the bladder but no further
- have had surgery called a trans urethral removal of bladder tumour (TURBT) to remove the tumours in the bladder
- have had chemotherapy and radiotherapy for bladder cancer before you joined this trial. The trial doctor checks the exact type of treatment you had to ensure you are suitable to take part.
- have had a CT scan within 8 weeks of joining the trial that shows the cancer hasn’t spread
- can start treatment within 42 days of having surgery, chemotherapy and radiotherapy for bladder cancer
- can start durvalumab or join the observation group within 2 days of being put into a group in the trial
- weigh more than 30kg (4.7 stone)
- have a sample of tissue (
biopsy) available for the trial team to do some tests on
- have satisfactory blood test results
- are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- are able to speak and read English well
- are willing to use reliable contraception during treatment and for 3 months after durvalumab if there is any chance you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply.
- have cancer that has spread elsewhere in the body
- have any other cancer unless it won’t affect you taking part in this trial
- have already had durvalumab, ipilimumab or similar drugs in the past
- have had a drug called
carboplatinin the past
You can’t take part if:
- have a heart problem that needs treatment such as congestive heart failure or angina
- have a tummy ulcer or inflammation of the tummy lining (gastritis)
- have an increased risk bleeding
- have a problem with your
- have had a severe reaction to an immunotherapy in the past
- have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the last month unless it was a very small dose, a cream or inhaler
- have had an
organ transplantand need to have treatment to damp down your immune system
- have an
autoimmune diseaseunless it is loss of skin colour (vitiligo), type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition that doesn’t need treatment within 3 years of joining this trial
- have had tuberculosis (TB)
- have HIV
- have an active hepatitis B or hepatitis C infection
- have a serious problem with your
digestive systemthat causes diarrhoea
- have moderate to severe numbness or tingling in your hands or feet
- have a condition called QT prolongation
- have a condition called interstitial lung disease such as inflammation of the lung (
- have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
You can’t take part if:
- are allergic to durvalumab or anything it contains
- have had a live
vaccinein the 30 days before being put into a treatment group
- are pregnant or breastfeeding
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:
- follow up appointments as usual (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.
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.
You have extra blood tests as part of this trial. Researchers are looking for:
- certain proteins that can help work out how well the treatment is working
- small pieces of the tumour that break away and circulate in the blood This is called circulating tumour DNA or ctDNA.
You have extra urine tests to look for
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:
- physical examination
- blood tests
- urine tests
- heart trace (
- heart scan (
MUGAor an ECHO)
- CT scan or PET-CT scan
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:
- 3 months for 2 years
- 6 months in the 3rd, 4th and 5th year of the trial
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:
- 3 months
- 6 months
- 9 months
- 1 year
And then every 3 months in the second year. The team can tell you how often you have them after that.
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:
- every 3 months to begin with
- then every 6 months
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:
- tiredness (fatigue)
- loss of appetite which may cause weight loss
- tummy (abdominal) pain and diarrhoea which may be severe
- muscle, joint, belly, back, chest pain or headache
- flu symptoms such as body aches, fever, chills, tiredness or loss of appetite
- shortness of breath
- feeling or being sick
- skin rash or itchy skin
drop in red blood cellswhich may cause tiredness
- liver changes
thyroid glandchanges which may cause you to feel tired, cold or lose or gain weight
- swelling of arms and or legs (fluid retention)
- changes in the level of salt in the body
- inflammation of the pancreas that may cause tummy pain
- inflammation of the lungs which could cause shortness of breath, chest pain or a new or worse cough
- high levels of sugar in the blood
We have information about:
How to join a clinical trial
Dr Simon Crabb
Cancer Research UK
University Hospital Southampton NHS Foundation Trust
Canadian Cancer Trials Group (CCTG)
This is Cancer Research UK trial number CRUKE/18/013.