
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 looking at whether it is possible to give less often for cancer that has spread.
The trial is open to people who have:
Doctors treat some types of cancer with an immunotherapy. This is the for advanced kidney cancer, melanoma and some bowel cancers. The immunotherapy drugs you might have include ipilimumab and nivolumab or pembrolizumab.
Immunotherapy works by helping the body’s to kill cancer cells. How often you have this depends on the specific drug you are having. Research suggests that this may be too often. You might be able to have treatment less often without affecting how well it works. The benefits of this could be:
Everyone joining this trial will have had or be having 12 weeks of immunotherapy. As part of this trial you then have more immunotherapy:
The main aims of this trial are to find out:
Please note, there are different treatment groups in this trial. Each group has specific entry conditions and we haven’t listed them all.
The following bullet points are a summary of the main entry conditions. 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 is a phase 2 trial. The team need 160 people in each group (cohort) to take part.
Everyone has or will have had 12 weeks of immunotherapy. This isn’t part of the trial. This is part of your routine treatment. You may have already had this when you join the trial. The 12 weeks of immunotherapy is:
You have a after you finish the 12 weeks of immunotherapy. This is before you join the trial. It is to check how well the immunotherapy worked. You can join this trial if your cancer hasn’t got worse and you fulfil all the
.
Trial treatment
You have nivolumab or pembrolizumab. You have nivolumab if you have renal cell cancer. If you have melanoma you have whichever treatment you had for the 12 weeks before starting on the trial. So you have either nivolumab or pembrolizumab.
You have nivolumab or pembrolizumab as a drip into a vein. Nivolumab takes about 60 minutes each time. Pembrolizumab takes about 60 minutes each time. You will be at the hospital for longer than this.
You have treatment for just under 2 years. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Renal cell kidney cancer group (part one)
This group is randomised. There are 2 treatment groups. Neither you nor your doctor can choose which group you are in.
You have one of the following:
Melanoma group (part one)
This group is randomised. There are 2 treatment groups. Neither you nor your doctor can choose which group you are in.
You have one of the following:
Part 2
When there are about 80 people in each group the team compare the schedules. This is to make sure that having the new schedule is working just as well as the standard one. When they are sure of this, they will go onto part 2.
In part 2 the team hope to test different schedules of nivolumab and pembrolizumab in more people. We will add more information about this when part 2 opens.
Samples for research
The researchers ask for a sample of cancer tissue () from when you were first diagnosed. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
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.
You see a doctor and have some tests before you join a trial. These include:
You have treatment at the hospital on the day care ward. During treatment you have regular blood tests and check ups with your doctor.
You have a CT scan every 12 weeks.
You see the doctor 8 weeks after you finish treatment.
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.
Nivolumab and pembrolizumab 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 immunotherapy include:
The trial team will talk to you about all the possible side effects of treatment. You will have a chance to ask any questions you may have.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Duncan Gilbert
Medical Research Council
Jon Moulton Charity Trust
University College London (UCL)
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.