
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is comparing 3 with the standard 6 cycles for urinary tract cancer that has spread.
It is for people who:
Urothelial cancer is a type of bladder cancer. Urinary tract cancer 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.
Chemotherapy is a usual treatment for urothelial cancer that has spread. It is usual to have 6 cycles of chemotherapy. You then have avelumab. It is a treatment for some people with urinary tract cancer. It is a type of immunotherapy. It helps your immune system to find and kill cancer cells.
In this trial researchers want to find out if having 3 cycles of chemotherapy makes people feel better. And if 3 cycles works just as well as 6 cycles.
In this trial you have one of the following standard combinations of chemotherapy:
The main aims of this trial are to find out if:
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 can’t join this trial if any of these apply. You:
This phase 2 trial is taking place in the UK, Spain and France. The team need about 244 people to take part including about 90 from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
Treatment
Your doctor will decide whether you have gemcitabine and cisplatin or gemcitabine and carboplatin. They will discuss this with you.
Depending on which group you are in you have 3 cycles or 6 cycles. Each treatment cycle lasts for 21 days. In each cycle you have:
You have gemcitabine, cisplatin and carboplatin as a drip into a vein. It takes about 60 minutes each time.
When you finish chemotherapy you start having avelumab. You have this as a drip into a vein. Each treatment cycle is 28 days. You have avelumab every 2 weeks. It takes about 60 minutes each time.
You have avelumab for up to 2 years as long as treatment is working and the side effects aren’t too bad.
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Sub study
The team ask you to take part in a . This involves wearing a small device on your wrist like a smart watch. It tracks and records your physical activity. The researchers hope this will help them to better understand how treatment affects your quality of life. You also fill in a short quality of life questionnaire. You do this on a mobile phone application (app).
The trial team will tell you more about the sub study. You can say no if you don’t want to take part. It won’t affect you taking part in the rest of the trial.
Samples for research
You give some extra blood and urine samples during treatment. You give the samples at specific times and the trial team will give you more information about this.
The trial team will ask to use a tissue sample of your cancer you gave when you had surgery or a biopsy.
They plan to use the samples to:
You see a doctor and have some tests before taking part. These tests include:
You have all your treatment in the hospital on the day ward. You shouldn’t need to stay overnight.
You have a CT or MRI scan at:
You stop trial treatment and scans if your cancer gets worse. Your doctor will talk to you about other treatment options.
Follow up
You see the trial team for a check up 30 days after your lost dose of treatment. They then call you every 3 months for 2 years to see how you are getting on. Or they may check your medical notes.
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.
Avelumab can 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. |
The most common side effects of avelumab are:
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Thomas Powles
Merck
Queen Mary University of London
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.