
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding nivolumab to rucaparib to improve treatment for ovarian cancer. It is also looking at adding nivolumab and ipilimumab to rucaparib.
It is for women who are going to have treatment for one of the following:
Treatment for these cancers is the same. So when we use ovarian cancer in the summary, we are referring to all 3 cancers.
Cancer Research UK supports this trial.
You might have rucaparib if your ovarian cancer comes back. It is a type of drug known as a . PARP is an enzyme that helps damaged cells to repair themselves. Cancer cells with gene changes already have problems repairing themselves.
The trial is open to people with either:
Ipilimumab and nivolumab are both immunotherapies. They help your find and kill cancer cells. They work in slightly different ways.
Researchers think that adding immunotherapy to rucaparib could improve treatment. They aren’t sure so want to find out more.
In this trial some people have rucaparib on its own. Some people have rucaparib and nivolumab. And some have rucaparib, nivolumab and ipilimumab.
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 the main part of the trial if you have one of the following cancers:
And 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 to find 234 people to take part.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 3 treatment groups.
You have 1 of the following:
How you have treatment
Rucaparib is a tablet. You take it twice a day every day. You have it for as long as it is working and the side effects aren’t too bad.
You have nivolumab as a drip into a vein. It takes about 30 minutes each time. You have nivolumab once every 2 weeks for up to a year.
You have ipilimumab as a drip into a vein. It takes about 30 minutes each time. You have it once every 6 weeks as a drip into a vein for up to a year.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Research samples
You give extra blood samples during the trial.
The team will ask for a piece of tissue from a previous tissue sample (). And they will ask to take some extra fresh biopsies during the trial.
They will use these samples to find what effect treatment has on the cancer and how well it works.
You see the doctor and have tests before you can take part. These include:
You have nivolumab and ipilimumab on the day care ward. You shouldn’t need to stay overnight.
You see the doctor every 2 weeks for the first 6 weeks while you are having treatment. You then see them every 6 weeks.
You have a CT scan or an MRI scan:
You stop having the trial scans if your cancer gets worse.
You see the doctor a month after you finish treatment and then about every 8 weeks. This might be at a routine hospital appointment or they might call you 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.
Having rucaparib alongside nivolumab and ipilimumab is a new treatment. So we don’t know about all the side effects yet. The doctors will keep a close eye on you and treat any problems straight away.
Nivolumab and ipilimumab 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. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. 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 nivolumab are:
The most common side effects of the combination of nivolumab and ipilimumab are:
The most common side effects of rucaparib include:
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them 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.
Professor Marcia Hall
Cancer Research UK
Bristol-Myers Squibb
University of Glasgow
NHS Greater Glasgow and Clyde
Clovis Oncology Inc
This is Cancer Research UK trial number CRUKE/17/017.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.