
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.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for men with prostate cancer that has spread to other parts of the body (metastatic).
It is for men who:
Prostate cancer needs the male sex hormone testosterone to grow. Testosterone is produced by the testicles. So, for advanced prostate cancer you might have:
But after some time, prostate cancer can start to grow again because the treatment has stopped working. This is called castration resistant prostate cancer.
You usually have chemotherapy for castration resistant prostate cancer. But doctors are looking for new ways to help men in this situation. In this trial, they are looking at 2 drugs called nivolumab and ipilimumab.
Nivolumab and ipilimumab are 2 types of immunotherapy. Both drugs seek out cancer cells by looking for proteins on the surface of the cancer cells and blocking them so that the recognises them and kills them.
This trial is in 2 parts. First, doctors test a sample of your cancer for:
Doctors call this immunogenic signature test. You go to the 2nd part of this trial if doctors find certain gene changes and a difference in the amount of proteins in the cell (positive immunogenic signature) that may make you more responsive to . In the 2nd part of this trial, you have nivolumab and ipilimumab.
The main aim of this trial is to find out whether nivolumab and ipilimumab help men with castration resistant prostate cancer who have a positive immunogenic signature test.
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 1st part of this trial if all of the following apply:
You may be able to join the 2nd part of this trial if all of the following also applies:
Who can’t take part
You cannot join the 1st part of this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
As well as the above, you cannot join the 2nd part of this trial if any of these also apply. You:
This is a phase 2 trial. Researchers need around 175 men to join the 1st part of this trial. They think that about 35 men will then have a positive immunogenic signature and be able to join the 2nd part.
This trial is in 2 parts:
Part 1 (pre screening)
Everyone gives a sample of tissue (archival tumour sample) for the immunogenic signature test. You need to have a biopsy if there isn’t a suitable sample available. Doctors look for:
It might take a number of weeks to get the results from the immunogenic test. Your doctor might suggest that you have other treatments during this time.
The trial doctor will tell you the results of the test when available. You then:
Part 2 (main study)
There are 2 groups. But the dose you have in each group is different. Group 1 is now closed. So if you join the study now you join group 2.
Everyone has 4 cycles of treatment with nivolumab and ipilimumab. Each cycle of treatment takes 3 weeks. You have both drugs as a drip into a vein on the 1st day of each cycle. It takes about 1 and a half hours each time you have it.
After 4 treatment cycles of nivolumab and ipilimumab, you have no treatment for 3 weeks in group 2. You then have nivolumab on its own every 4 weeks. This continues for up to a year.
Blood tests
You have extra blood tests as part of this trial. Researchers want to look at the effect nivolumab and ipilimumab has in your body.
You have the extra blood tests before the start of treatment and at set times during the trial.
You see a doctor and have some tests before taking part in the 2nd part of this trial. These tests might include:
During treatment, you see the trial doctor each time you have nivolumab and ipilimumab. You have blood tests, a heart trace and a physical examination each time you see them.
You have a CT scan and bone scan every 9 weeks for about 6 months. You then have a CT scan or bone scan every 12 weeks.
You continue to have treatment for as long as it is working and the side effects aren’t too bad. It can be for up to a year.
When you finish treatment, you see the trial doctor after a month. You then see them:
The trial team monitor you during the time you have treatment with nivolumab and ipilimumab, and afterwards. 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 treatment. The most common side effects of nivolumab and ipilimumab are:
The most common side effects of nivolumab alone are:
We have more information about the possible side effects of nivolumab and ipilimumab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Mark Linch
University College London
Bristol-Myers Squibb
Cancer Research UK
Rosetrees Trust
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.