ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)
The ATHENA study is testing a maintenance treatment for women with advanced ovarian, fallopian tube, or peritoneal cancer. Maintenance treatment is given after successful initial chemotherapy to help stop or delay the cancer coming back. Researchers are testing two drugs: rucaparib, a daily tablet that blocks cancer cells from repairing themselves, and nivolumab, an immunotherapy drip given into a vein to help the immune system fight cancer. Participants will receive either these active medicines, a combination of one medicine and a dummy treatment (placebo), or placebos alone. Because this is a double-blind trial, neither you nor your doctor will know which group you are in. Doctors will closely track your health, side effects, and regular scans to see if this approach keeps the cancer from growing for longer than current care options.
At a glance
What is this study about?
Ovarian cancer, along with cancer of the fallopian tubes and peritoneum (the lining of the tummy), is often treated first with platinum-based chemotherapy. While this initial treatment frequently shrinks or clears the cancer, there is a high chance the cancer may return over time. Because of this, doctors are looking for effective 'maintenance' therapies—treatments taken after chemotherapy to keep the disease under control for as long as possible.
The ATHENA trial is studying whether two newer cancer drugs, given together or alone, can delay the cancer returning. The first drug is rucaparib (Rubraca), a tablet known as a PARP inhibitor. It stops cancer cells from fixing their damaged DNA, causing them to die. The second is nivolumab (Opdivo), an immunotherapy medicine given through a drip that helps your body's natural immune system detect and attack cancer cells.
To find out how well these medicines work, researchers compare them against a placebo (a dummy treatment). Understanding whether these medicines safely extend the time a person lives without their cancer growing could help shape future NHS treatments and offer new hope for people diagnosed with advanced ovarian cancers.
Key takeaways
- The trial tests if rucaparib and nivolumab can delay ovarian cancer from returning.
- It is for women with advanced ovarian, fallopian tube, or peritoneal cancer who responded well to initial chemotherapy.
- Treatment involves daily tablets and regular hospital drip infusions.
- This is a double-blind trial, meaning some participants receive dummy treatments (placebos).
- You will be closely monitored with regular blood tests and body scans.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adult women aged 18 and over who have been diagnosed with advanced (stage 3 or stage 4), high-grade epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
To be considered, you must have recently completed your first course of standard platinum-based chemotherapy, and the treatment must have been successful in shrinking or clearing your tumours. Your overall health and daily fitness will also be checked to make sure it is safe for you to take part.
You will not be able to join if your cancer did not respond to your initial chemotherapy, if you have certain other medical conditions that could make the trial drugs unsafe, or if you cannot manage regular clinic visits and scans.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a woman aged 18 or older.
- I have advanced (stage 3 or 4) ovarian, fallopian tube, or peritoneal cancer.
- I have recently finished my first course of platinum chemotherapy.
- My cancer responded well (shrank or went away) after my chemotherapy.
- I am well enough to attend regular clinic visits and have routine scans.
What does participation involve?
If you decide to take part, you will be placed into a treatment group by chance (randomly). You will take tablets (either rucaparib or a matching dummy tablet) by mouth every day, and you will receive an infusion into a vein (either nivolumab or a dummy drip) at the hospital clinic every few weeks. Neither you nor your care team can choose or know which combination you receive.
During your visits, you will have regular safety checks. These include physical examinations, blood and urine tests, heart and vital sign checks, and questions about how you are feeling. You will also have scheduled imaging scans, such as CT or MRI scans, to see how your body is responding to the treatment.
You will continue receiving the study treatment for as long as it helps you and the side effects remain manageable, or until the trial ends. After treatment stops, the medical team will continue to stay in touch with you periodically to check on your long-term health and well-being.
Potential risks and benefits
Locations (11)
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedGreece
- —UnverifiedIreland
Common questions
What is maintenance therapy?
Maintenance therapy is treatment given after your main chemotherapy has worked. Its goal is to slow down or prevent the cancer from returning.
Why is a placebo used in this trial?
A placebo looks just like the real medicine but contains no active drug. It allows researchers to prove whether any health improvements or side effects are truly caused by the study medicines.
Can I choose which treatment I get?
No. A computer assigns you to a group by chance. This ensures the trial results are completely fair and scientifically accurate.
Will taking part cost me anything?
No, the study medicines and trial-related tests are provided free of charge. Many trials also help cover travel expenses to and from the hospital.
What happens if I change my mind?
You can leave the study at any point. Your decision will not change your relationship with your healthcare team, and you will return to standard NHS care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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