
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is looking at having atezolizumab directly into the bladder followed by surgery.
It is for people who are due to have surgery to remove their bladder (a
Urothelial cancer is a type of bladder cancer. It can start in the:
The lining of the urinary tract is called the urothelium. So cancer of the urinary tract can also be called urothelial cancer.
Treatment into the bladder and surgery to remove it are common treatments for bladder cancer.
Doctors are looking at ways to improve treatment for bladder cancer to reduce the need for surgery. In this trial they are looking at a drug called atezolizumab. It is an immunotherapy. It helps the to find and kill cancer cells.
Atezolizumab is already a treatment for bladder cancer that has spread elsewhere in the body. The usual way to have this is as a drip into the bloodstream.
Doctors think that for bladder cancer, it might be better to have atezolizumab directly into the bladder. This is rather than having it in the usual way as a drip into the bloodstream.
In this trial you have atezolizumab into the bladder before having surgery to remove it.
The team plan to give atezolizumab using 2 different methods:
This is the first time people are having atezolizumab in these ways.
The main aims of the trial are to find out:
The following bullet points are a summary of 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
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This phase 1 trial is taking place in Sheffield.
Everyone has atezolizumab into the bladder in 1 of the following ways by:
The method you have depends on when you join the trial. Your doctor will tell you more about the method you will have.
Atezolizumab into the bladder (passive instillation)
You have atezolizumab into your bladder through a thin tube (catheter). The catheter goes into your bladder through the urethra. The urethra is the tube that carries wee (urine) from the bladder out of the body. The doctor or nurse puts in the catheter on the day unit. You have this done under . You must not pass urine for at least an hour after the procedure.
This is the usual way to have other standard of care drugs into the bladder such as BCG.
Atezolizumab as injections into the bladder (direct injection)
This involves injecting the atezolizumab directly into the tumour. To do this the doctor uses a narrow telescope (called a cystoscope). This goes into your bladder through the urethra. The drug is then injected into the tumours and the bladder wall. You have this done under local anaesthetic.
Finding the best dose and schedule of atezolizumab
For both methods, the first few people have a low dose of atezolizumab. The next few people have a higher dose if they don’t have any side effects. This helps the doctors to confirm the best dose. Between 6 and 42 people join this part.
When they find this dose, they test it in more people. About 20 people join this part.
Some people have one dose of atezolizumab. And some people have more than one dose. Those having more than one dose have it once a week for 3 to 6 weeks.
The dose you have and how many depends on when you join the trial. The team can tell you more about this.
When this treatment is finished you have your surgery as planned.
Surgery
Trial treatment will fit in before your planned surgery. This means your surgery won’t be delayed by taking part in this trial. Everyone has surgery within 1 to 4 weeks after the last dose of atezolizumab.
Your doctor will tell you what surgery to remove the bladder involves and how long you’ll be in hospital for.
Samples for research
The researchers might ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests. They also ask you to give extra urine samples. And they take samples of cancer tissue when your bladder is removed.
They plan to use the samples to:
You see a doctor and have some tests before you can take part in this trial. These include:
The team might also ask you to have an MRI-PET scan.
One week after you finish trial treatment and before surgery you have:
You see the doctor for regular blood tests and check ups. This is part of your routine care after bladder cancer surgery.
One month after surgery, you have a test that looks at the whole of your urinary system. This is called an intravenous urogram (IVU). You have another CT scan 3 months after surgery. These are standard tests that you have after bladder surgery. You would have them even if you weren’t in the trial.
You have a final check up with the doctor about 3 months after surgery. The team then continue to see how you are getting on. They do this by checking your hospital notes. You won’t have to go to the hospital for extra visits.
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.
Having atezolizumab into the bladder might affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
Having atezolizumab directly into the bladder is a new way of having it. This is the first time people are having it in this way. The doctors doing this trial think it is safe to have it into the bladder.
Giving cancer treatment into the bladder does not normally have as many other side effects as having tablets or injections. This is because the drug tends to stay in the bladder and very little gets into the bloodstream. We do not know how much atezolizumab, if any, will get into your bloodstream. If it does you may have side effects in parts of the body other than the bladder. The team will tell you what these are and what to look out for.
The side effects of other cancer treatments that are given directly into the bladder can include:
These side effects are normally mild and often settle within a day or two. If they go on for longer or are severe your doctor may need to give you other medications to help with your symptoms.
The team will tell you about all the possible side effects before you start treatment. You’ll have a chance to ask them any questions you may have.
We have more information the following treatments and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Syed Hussain
F. Hoffmann - La Roche, Limited
Leeds Institute of Clinical Trials Research at the University of Leeds and the University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”