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 Open a glossary item or BRCA2 Open a glossary item 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 Open a glossary item that has come back after treatment with a platinum chemotherapy drug Open a glossary item 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 Open a glossary item for ovarian cancer
  • had treatment for ovarian cancer between 3 and 12 months ago that included a platinum drug
  • have a change (mutation Open a glossary item) in BRCA1 Open a glossary item, BRCA2 Open a glossary item 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 Open a glossary item) 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 Open a glossary item, immunotherapy or any other cancer treatment within 28 days of starting trial treatment   
  • have already had a PARP inhibitor Open a glossary item 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 Open a glossary item 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 Open a glossary item, DCIS Open a glossary item 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 Open a glossary item 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 Open a glossary item or you have had a blood or platelet transfusion Open a glossary item 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 Open a glossary item which means you can’t absorb rucaparib
  • have a problem with how your immune system Open a glossary item 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 Open a glossary item in the past 
  • have an active autoimmune condition Open a glossary item 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 Open a glossary item)
  • have had major surgery within 3 weeks or minor surgery within 5 days before joining the trial
  • have a severe liver problem Open a glossary item
  • 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 Open a glossary item 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

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 Open a glossary item
  • blood tests
  • heart trace (ECG Open a glossary item)
  • 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:

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)

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:

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Marcia Hall

Supported by

Cancer Research UK
Bristol-Myers Squibb
University of Glasgow
NHS Greater Glasgow and Clyde
Clovis Oncology Inc

Other information

This is Cancer Research UK trial number CRUKE/17/017.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15465

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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