
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new combination of treatment for kidney cancer that has spread elsewhere in the body or if surgery to remove it is not possible.
It is for people who have already had an immunotherapy.
You might have an immunotherapy for kidney cancer that has spread. But sometimes it doesn’t work or stops working. So researchers are looking for ways to improve treatment. In this trial they are looking at a combination of 2 drugs called:
Pembrolizumab is an immunotherapy. It helps the to find and kill cancer cells.
Cyclophosphamide is a standard chemotherapy drug used to treat many types of cancer. Recently researchers have found that it can change the type of immune system cells close to tumours. These changes may help the immune system to recognise and attack or kill cancer cells. The researchers think that having it with drugs that stimulate the immune system might help it more.
Researchers hope that having the 2 drugs together may help your immune system to find and kill cancer cells. Even if previous immunotherapies have not worked or have stopped working.
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 the trial if any of the following apply:
You:
Other
You can’t take part if you:
This is a phase 1 trial. It is taking place in the UK. The team hope to find 21 people to take part.
Everyone has cyclophosphamide and pembrolizumab.
Cyclophosphamide is a tablet you take once a day, everyday.
You have pembrolizumab as a drip into a vein. You have this once every 3 weeks.
To begin with you take cyclophosphamide for 21 days. You then have your first dose of pembrolizumab. It takes around 30 mins each time. You will be at the hospital for longer than this.
You continue to have cyclophosphamide and pembrolizumab for about 2 years. You have this for as long as treatment is working and the side effects aren’t too bad.
Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. The team would also like to collect 3 extra tissue samples.
They plan to use the samples to:
You see a doctor and have some tests before you can join the trial. These include:
You have pembrolizumab at the hospital in the outpatient department.
You have a CT scan every 9 weeks.
When you stop treatment you see the team for a check up 1 month later. You have a CT scan every 9 weeks if you stopped treatment but the cancer hadn’t got worse. You have scans until your cancer starts to grow or you start another treatment for your cancer.
You have follow up every 3 months if you stopped treatment because your cancer got worse. A member of the research team calls you to see how you are 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.
Pembrolizumab 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 that you are on or have been on an immunotherapy. |
The common side effects of pembrolizumab are:
The most common side effects of cyclophosphamide include:
We have more information about the side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Tom Waddell
Merck, Sharp & Dohme
The Christie NHS Foundation Trust
Cancer Research UK Manchester Institute Cancer Biomarker Centre
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.”