
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.
This trial is for people with bladder cancer that has spread to the nearby tissues or to another part of the body (advanced bladder cancer).
It is for people going to the Royal Marsden Hospital in Surrey.
Advanced bladder cancer is often treated with radiotherapy. This uses high energy waves similar to x-rays to shrink the cancer and help to control the symptoms.
Pembrolizumab (Keytruda) is a type of targeted therapy called a monoclonal antibody. It helps the to attack the cancer and stops it from growing.
Pembrolizumab is already used to help people with other types of cancer such as melanoma and non small cell lung cancer. But doctors want to find out if it can also help people with advanced bladder cancer.
In this trial you have radiotherapy and pembrolizumab. The dose of pembrolizumab you have depends on when you join the trial.
The main aims of this 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.
You may be able to join this trial if all of the following apply.
You cannot join this trial if any of these apply.
Cancer related
Medical conditions
Other
This is a phase 1 trial. The researchers need around 28 people who are going to The Royal Marsden Hospital to take part.
You have pembrolizumab and radiotherapy.
Pembrolizumab
You have pembrolizumab as a drip into a vein. It takes about 30 minutes each time.
The first few people taking part have a low dose of pembrolizumab. If they don’t have any serious side effects, the next few people have a higher dose. And so on, until doctors find the best dose.
You have pembrolizumab:
This continues for as long as it helps you and the side effects aren’t too bad. You can have it for up to 1 year.
Radiotherapy
You have a radiotherapy planning scan. The scan helps doctors know how much radiation you need and exactly where you need it. Then you start radiotherapy.
You have radiotherapy once a week, for 6 weeks.
Blood tests
You have 4 extra blood tests as part of this trial. The researchers want to:
You have the extra blood samples at the same time you have routine blood tests.
Sample of tissue
Researchers will ask to use a sample of your cancer taken either when you were diagnosed or during any treatment you’ve had. They want to look for substances (markers) that affect how cancer develops and how treatment works.
If there isn’t a suitable sample available, you might have a new sample taken (a biopsy).
The research team might also ask you to have a new tissue sample taken 18 weeks (around 4 ½ months) after the start of treatment. This is only if you have bladder cancer that has spread to the nearby tissues.
You see a doctor and have some tests before taking part. These tests might include:
During treatment, you see the doctor for blood tests and a physical examination before each pembrolizumab treatment.
You have a CT scan 12 weeks after the start of treatment and then:
This continues for as long as your cancer stays the same and does not get worse. If your cancer gets worse you stop having treatment.
When you finish treatment you see the trial doctor after a month. You have blood tests and a physical examination. After this, you see the doctor as part of your regular follow up.
The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body. This 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 tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.
The most common side effects of pembrolizumab are:
We have more information about pembrolizumab.
We also have information about radiotherapy side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Robbert Huddart
Biomedical Research Centre (BRC)
Institute of Cancer Research (ICR)
Merck Sharp and Dohme (MSD)
National Institute for Health Research (NIHR)
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
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.