
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at ipilimumab and nivolumab or nivolumab on its own for kidney cancer.
It is for people having surgery for kidney cancer who have a high risk of the cancer coming back.
To treat kidney cancer you can have surgery to remove the whole kidney or part of it. But some people have a higher risk of the cancer coming back. So researchers are looking at having treatment after surgery. In this trial they are looking at 2 drugs called nivolumab and ipilimumab. These drugs are already used for people whose kidney cancer has spread elsewhere in the body.
Nivolumab and ipilimumab are both types of immunotherapies. They work in different ways to help the immune system to find and kill cancer cells.
In this trial everyone has surgery and:
The main aims of the trial are to find out:
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.
Who can take part
You may be able to join the trial if one of the following applies. You:
As well as the above, all of the following must apply. You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This phase 3 trial is taking place worldwide. The researchers hope to find 1,600 people to take part including 80 from the UK.
There are 2 parts to this trial, part A and part B. Your doctor will tell you whether you will join part A or part B. Please note that part A is now closed. Part B is open for people to join.
This is a randomised trial. In each part a computer puts you into a treatment group. Neither you nor your doctor can decide which treatment you have. Nor will you know which treatment group you are in.
Part A (closed to recruitment)
In part A there are 2 treatment groups. People have 1 of the following:
Part B (open to recruitment)
In part B there are 3 treatment groups. You have 1 of the following
A quarter of those randomised have nivolumab and ipilimumab, a quarter have both dummy drugs and half have nivolumab and a dummy drug.
Depending on which group you are in you have:
You have treatment for up to 6 months.
Samples for research
The researchers ask for a sample of tissue from your surgery. They also ask for a sample from when you were first diagnosed. You give some extra blood samples as part of the trial.
The researchers plan to look for:
This will help them to understand more about kidney cancer and how best to treat it.
You see the doctor to have some tests before taking part in the trial. These include:
You have treatment at the hospital in the outpatient department.
You have a CT or MRI scan at:
When you stop treatment you see the team for a check up at 1 month and 3 months. After that the team call you every 3 months to see how you are getting on.
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 or ipilimumab can affect the immune system. They 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. You should tell them that you are on or have been on an immunotherapy. |
The most common side effects of nivolumab are:
The most common side effects of the combination of nivolumab and ipilimumab are:
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 Thomas Waddell
Bristol-Myers Squibb
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”