A trial looking at adding immunotherapy to rucaparib for ovarian cancer that has come back (Centurion)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 2

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:

ovarian cancer
fallopian tube cancer
primary peritoneal cancer

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.

More about this trial

You might have rucaparib if your ovarian cancer comes back. It is a type of drug known as a PARP inhibitor Open a glossary item . 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:

a change in the BRCA1 or BRCA2 genes or
those who have a normal BRCA gene but have a lot of scarring in the gene

Ipilimumab and nivolumab are both immunotherapies. They help your immune system Open a glossary item 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:

if adding immunotherapy increases the length of time before the cancer starts to grow again
more about the side effects

Who can enter

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:

have a high grade cancer that has come back after treatment with a platinum chemotherapy drug such as carboplatin
have had at least one course of chemotherapy in the past that included a platinum drug
have had no more than 3 different courses of chemotherapy for ovarian cancer
had treatment for ovarian cancer between 3 and 12 months ago that included a platinum drug
have a change (mutation ) in BRCA1 , BRCA2 or a normal BRCA gene with higher levels of DNA change (genomic scarring)
have cancer that your doctor can measure on a scan
are willing to give a sample of tissue (biopsy ) before you start treatment
can swallow tablets
have satisfactory blood test results
are willing to use reliable contraception if there is any chance you could become pregnant
are fully active but might not be able to do heavy physical work (performance status 0 or 1)
are at least 16 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

have had chemotherapy, a targeted drug, radiotherapy, hormone treatment , immunotherapy or any other cancer treatment within 28 days of starting trial treatment
have already had a PARP inhibitor or certain types of immunotherapy in the last 6 months. Your doctor will know this.
have had a PARP inhibitor in combination with certain types of immunotherapies in the last 6 months
have cancer that has spread to the brain or the tissues surrounding the brain or spinal cord compression unless it has been treated and is stable
have had an experimental treatment within 4 weeks of starting treatment in this trial
have another cancer that is getting worse or needed treatment in the last 2 years. This doesn’t include non melanoma skin cancer , DCIS of the breast, in situ or very early cervical cancer, womb cancer or vulval cancer

Medical conditions
You cannot join this trial if any of these apply. You:

have long term kidney problems that aren’t well controlled
have a significant heart problem that isn’t well controlled with medication. Your doctor checks your heart before you join the trial.
are having treatment to boost the number of blood cells or you have had a blood or platelet transfusion in the 2 weeks before you start trial treatment
have been in hospital in the last 3 months with a blocked bowel
have a problem with your digestive system which means you can’t absorb rucaparib
have a problem with how your immune system works
are having treatment that damps down the immune system. This includes steroids within 1 week of starting trial treatment unless it was a low dose.
have a bleeding problem
are taking warfarin
have HIV, an active hepatitis B or hepatitis C infection, another infection that needs treatment or you have had tuberculosis in the past
have an active autoimmune condition that needed treatment in the last 2 years apart from certain ones. Your doctor will know this.
have bad side effects from past treatment that aren’t getting better. This doesn’t include hair loss or numbness and tingling in the hands or feet (peripheral neuropathy )
have had major surgery within 3 weeks or minor surgery within 5 days before joining the trial
have a severe liver problem
have scarring of the lungs (interstitial lung disease)

Other
You cannot join this trial if any of these apply. You:

are allergic to rucaparib, nivolumab or ipilimumab or anything they contain
have had a live vaccination within 30 days of starting trial treatment
have a problem with drugs or alcohol
are pregnant or breastfeeding

Trial design

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:

rucaparib on its own
rucaparib and nivolumab
rucaparib, nivolumab and ipilimumab

CeNtuRIOn trial - randomisation diagram

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 (biopsy Open a glossary item ). 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.

Hospital visits

You see the doctor and have tests before you can take part. These include:

a physical examination
blood tests
heart trace (ECG )
CT scan or MRI scan

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:

every 2 months in the first year and then
every 4 months

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.

Side effects

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:

a reaction to the infusion that can happen during or afterwards. You might get chills, a fever, muscle pain, shortness of breath, low or high blood pressure
tiredness (fatigue)
feeling sick

The most common side effects of the combination of nivolumab and ipilimumab are:

a reaction to the infusion that can happen during or afterwards
tiredness
feeling or being sick
headache
loss of appetite and weight loss
skin rash or itchy skin
diarrhoea
difficulty falling or staying asleep

The most common side effects of rucaparib include:

feeling sick
tiredness
dizziness
difficulty sleeping
itchy skin or skin rash
difficulty breathing
changes to the liver or kidney
a drop in blood cells causing an increased risk of infection, bruising and bleeding, shortness of breath and tiredness
low levels of phosphate in the blood
loss of appetite
diarrhoea or constipation
stomach pain and indigestion
increased amount of cholesterol in the blood
fever
colds and sneezing (upper airway infections)