"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of MPDL3280A for bladder cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called MPDL3280A for bladder cancer that has grown into surrounding tissue or spread to another part of the body. The people taking part have a type of cancer called urothelial cancer (also known as transitional cell cancer or TCC). This can start in
- The bladder
- The kidneys
- The tube that carries urine from the bladder to the outside of the body (urethra)
- The tubes that carry urine from each kidney to the bladder (ureters)
If urothelial cancer has grown into surrounding tissue (locally advanced) or has spread to another part of the body (metastatic cancer), doctors may treat it with chemotherapy. But researchers are looking for new treatments to help people in this situation.
In this trial, they are looking at a drug called MPDL3280A which may help your immune system to stop or slow down cancer growth.
The aims of this study are to
- See if MPDL3280A helps people with urothelial cancer
- Learn more about the side effects and what happens to the drug in your body
Who can enter
You may be able to join this trial if all of the following apply. You
- Have transitional cell cancer (TCC) that has grown into local tissue and can’t be removed with surgery or has spread to another part of your body
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for at least 6 months afterwards if there is any chance you or your partner could become pregnant
There are 2 groups of people in this trial. People joining group 1
- Haven’t had any chemotherapy for advanced cancer (you may have had chemotherapy before or after surgery to remove cancer from your bladder as long as it was at least a year after you finished this treatment before your cancer came back)
- Finish any other treatment into their bladder (
intravesical treatment) at least 4 weeks before starting the trial drug
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
People in group 2
- Have had chemotherapy for advanced cancer that included a
platinum drugbut the cancer got worse despite having this treatment
- Are well enough to carry out all their normal activities, apart from heavy physical work (performance status of 0 or 1)
You cannot join this trial if you
- Have problems with your kidneys or with your hearing
- Have damage to nerves in your hands or feet (peripheral neuropathy) unless this is only mild
- Have cancer that has spread to your brain. You may be able to take part if you have cancer spread to your brain that has been treated, as long as scans show it hasn’t got worse since that treatment finished, it isn’t causing any symptoms, you don’t need to take
steroids, and if you take other medication to prevent fits, the dose you take has not changed for a while (the trial team can advise you about this)
- Have cancer that has spread to the layers of tissue covering your brain (leptomeningeal disease)
- Have had any other cancer treatment in the last 3 weeks (you may have had radiotherapy to treat symptoms of cancer spread to the bone, as long as this finished at least a week ago)
- Have had another experimental drug as part of a clinical trial in the last 4 weeks
- Have major surgery in the 4 weeks before starting the trial drug
- Have a vaccination in the 4 weeks before starting the trial drug
- Have pain related to your cancer that can’t be controlled
- Have a build up of fluid in your lungs, heart or tummy (abdomen) that needs draining at least once a month
- Have large amounts of calcium in your blood and the level can’t be reduced with medication
- Have had an
- Have certain lung conditions (the trial team can advise you about this)
- Are HIV positive
- Have tuberculosis, hepatitis B or hepatitis C
- Have had a serious infection in the last 4 weeks, or have had antibiotics in the last 2 weeks
- Have had a heart attack in the last 3 months, or have certain other heart problems (the trial team can advise you about this)
- Have had a
bone marrow transplantor another organ transplant
- Have any other medical condition that the trial team think could affect you taking part
- Have taken steroids or other drugs that affect your immune system in the last few weeks (the trial team can advise you about this)
- Have had an allergic reaction (or other serious reaction) to any drugs that are similar to MPDL3280A, or that are produced in a similar way
- Have had any other cancer in the last 5 years, apart from certain cancers that were very early stage and have been successfully treated (the trial team can advise you about this)
- Are pregnant or breastfeeding
This is an international phase 2 trial. In total, the researchers need about 400 people to take part. Everybody taking part will have MPDL3280A, but there are 2 different groups of people in this trial.
In group 1 there will be about 100 people who haven’t had any chemotherapy for advanced bladder cancer.
In group 2, there will be about 300 people who have had chemotherapy for advanced bladder cancer, but their cancer got worse despite having this treatment.
People in both groups have MPDL3280A through a drip into a vein (an infusion) once every 3 weeks. The first time you have it, this takes an hour. If you don’t have any problems with this, you can have the following infusions over half an hour.
People in group 1 can carry on having MPDL3280A until their cancer starts to get worse. The people in group 2 can carry on having the drug for as long as the trial doctor can see it is helping with any symptoms they have, even if a scan shows their cancer may have got worse.
You see the trial team and have some tests before you start treatment. The tests include
The researchers need a sample of your cancer to look for
If it’s possible, the trial team will also ask you to have another biopsy if a scan shows that your cancer appears to be getting worse.
You go to hospital once every 3 weeks to see the trial team and have blood tests, as well as having an infusion of MPDL3280A. Each visit lasts 3 to 4 hours. You have regular scans until the trial team can see that your cancer is getting worse. These will be every 9 weeks for the first year of treatment and then every 3 months after that.
When you stop having treatment, you go to hospital to see the trial team once more. After that, they will ask your permission to contact you by phone every 3 months to see how you are.
If you stop having the trial treatment for any reason other than your cancer getting worse, the trial team will ask you to have follow up visits and scans. These will continue until your cancer does get worse, or the trial finishes, or you are no longer willing to do this.
As MPDL3280A is a new drug, there may be side effects we don’t know about yet. In earlier trials, the most common side effects have been
- Tiredness (fatigue)
- Feeling or being sick
- Loss of appetite
- A drop in the number of red blood cells causing tiredness
- Shortness of breath
- High temperature (fever)
- Joint pain
- Itching skin
- Problems sleeping
- Lack of energy
- Tummy (abdominal) pain
- Generalised pain and back pain
- Swelling of your hands and feet due to a build up of fluid
It is important that you tell the trial team straight away if you have any side effects or notice any changes in your condition. They will advise you what to do and give you medication to help.
You must not take any herbal medicines during the trial. And you mustn’t take any other medication that can affect your immune system during treatment, or for 10 weeks after your last dose of MPDL3280A. It is also important that you talk to your trial doctor before having any vaccinations.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Thomas Powles
F. Hoffmann - La Roche
NIHR Clinical Research Network: Cancer