A study in ovarian cancer patients evaluating rucaparib and nivolumab as maintenance treatment following response to front-line platinum-based chemotherapy (ATHENA)
Who can take part
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
You may be eligible to take part in the study if you:
- have a newly diagnosed, stage III or IV high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has responded to chemotherapy
- are aged 18 and over
- have had surgery for your cancer
- have overall good levels of wellbeing and activity.
This is not an exhaustive list. Women interested in participating in a clinical trial should speak to their own doctor about what other criteria might apply.
About the trial
This trial looks to answer the question as to whether two different types of anti-cancer drugs, given as maintenance treatment are:
Maintenance treatment refers to drugs that are given to try to slow or prevent or delay the cancer's return after it has responded to chemotherapy.
There are three drugs used in this trial.
- An oral drug that belongs to a class of anti-cancer agents known as PARP inhibitors. This will be taken twice daily.
- PARP is a protein inside cells that helps repair damage to DNA, which is the genetic material that carries the instructions for your body's growth and development, and allows cells to continue on living. Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing.
- A drug given intravenously (through a needle placed in a vein) once every four weeks.
- This is a drug known as an anti-programmed death receptor-(PD)-1 inhibitor.
- Nivolumab can block cancer's ability to hide itself and helps your T cells (part of your immune system) to be active and attack cancer cells again.
- A placebo is an inactive drug or treatment used in a clinical trial. It's sometimes referred to as a 'sugar pill'. In this trial the placebo will be either an inactive tablet or a saline or glucose infusion (do not contain an active drug). The placebo is designed to look like the medicine being tested, but it isn't active. Using a placebo in this way can help prevent patients and their doctors from figuring out which treatment group they were assigned to and to try and prevent bias in the results of the study.
- It's common for ovarian cancer patients who have responded to chemotherapy to wait and see what happens next. Therefore, in this case, a placebo arm is no different than a maintenance phase where a patient has follow up testing but is not taking any medication for cancer treatment.
Women who enter the trial will be randomised (allocated into a treatment group by a computer) into one of four treatment groups.
- Group one: oral rucaparib + intravenous (IV) nivolumab
- Group two: oral rucaparib + intravenous (IV) placebo
- Group three: oral placebo+ intravenous (IV) nivolumab
- Group four: oral placebo + intravenous (IV) placebo
As part of this trial, samples of tumour tissue and blood will also be collected to look for biomarkers. Biomarkers are substances such as genetic material (DNA) and proteins found in blood and tumour tissue that might show if a cancer patient will respond or not respond to a treatment.