A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
This research study, called KEYLYNK-001, is looking at new ways to treat advanced ovarian cancer when it doesn't involve a specific gene change called BRCA. The main idea is to see if adding two new drugs, pembrolizumab and olaparib, to standard chemotherapy can help women live longer without their cancer growing. Pembrolizumab works by helping your body's immune system fight cancer, and olaparib targets cancer cells in a different way. The study will compare these new treatments to standard care, which might include a dummy medicine (placebo) instead of the new drugs. Researchers will closely watch how long patients stay well and whether the treatment affects their quality of life. This is a large study (Phase 3) aiming to confirm if these new treatments are effective and safe.
At a glance
What is this study about?
This study is a big, important piece of research looking into advanced epithelial ovarian cancer. This is a type of cancer that starts in the outer layer of the ovary.
The study wants to find out if adding two newer drugs, pembrolizumab and olaparib, to standard chemotherapy can help women with this condition live longer without their cancer growing. Chemotherapy uses strong medicines to kill cancer cells. Pembrolizumab is a type of immunotherapy, which means it helps your body's own immune system fight the cancer. Olaparib is a 'targeted therapy' that looks for specific weak spots in cancer cells to attack them.
Crucially, this study is for women whose ovarian cancer does *not* have a specific gene change called a BRCA mutation. Researchers are particularly interested in how these new treatments work for this group of patients. The study is comparing these new treatment combinations against the usual treatments, which might include a dummy medicine (called a placebo) to make sure the results are fair and accurate. They will be carefully checking how long the cancer stays controlled and how the treatments affect a patient's daily life and general well-being.
Key takeaways
- This study is testing new combinations of drugs for advanced ovarian cancer.
- It's for women whose cancer does not have a BRCA gene mutation.
- The new drugs aim to stop cancer growth and improve quality of life.
- Participants will receive either the new treatment or standard care (which may include a placebo).
- It's a 'Phase 3' study, meaning it aims to confirm if these new treatments are effective and safe.
Who may be eligible?
To join this study, you must be a woman aged 18 or older.
Your advanced epithelial ovarian cancer must not have a specific genetic change called a BRCA mutation. This is important because the study is specifically looking at how the treatments work for this particular type of ovarian cancer.
Your doctor will carry out various tests to make sure you fit all the necessary health requirements to take part safely.
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.
- Are you a woman aged 18 or older?
- Do you have advanced epithelial ovarian cancer?
- Has your doctor confirmed your cancer does not have a BRCA gene mutation?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you willing to potentially receive a placebo instead of active study drugs for some parts of the treatment?
What does participation involve?
If you join this study, you will receive either the new treatments (chemotherapy plus pembrolizumab followed by olaparib) or standard treatment (chemotherapy plus a dummy medicine, or placebo, followed by a placebo). The doctors and nurses, and you, won't know which treatment you are receiving – this is called 'double-blinded' to make the study results as fair as possible.
You will have regular hospital visits for your treatments and check-ups. These visits will involve blood tests, scans, and physical examinations to see how you are responding to the treatment and to monitor your health. You will also be asked to answer questionnaires about your general health and how you are feeling, which helps researchers understand your quality of life.
The total duration of the study treatment can vary, but generally, you will continue with follow-up appointments even after active treatment has finished to keep track of your health and the cancer over time.
Potential risks and benefits
Locations (8)
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is advanced epithelial ovarian cancer?
This is a type of cancer that starts in the outer lining of the ovaries and has spread beyond the original site.
What does 'BRCA non-mutated' mean?
It means your ovarian cancer does not have a specific inherited gene change called a BRCA mutation, which is important for how certain treatments work.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps researchers compare the effects of new treatments accurately.
What is the aim of adding pembrolizumab and olaparib?
The study wants to see if adding these drugs to chemotherapy can help control the cancer for longer and improve patients' overall health, especially for those without BRCA mutations.
Will I know which treatment I'm receiving?
No, this study is 'double-blinded,' meaning neither you nor your doctors will know if you are receiving the new drugs or the placebo to ensure fair results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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