A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients with Recurrent Ovarian Cancer.
This research study is for women with advanced ovarian cancer that has returned after initial treatment, and whose cancer does not have a specific BRCA gene mutation. Doctors are trying to find out if giving combinations of new medicines can help keep the cancer from growing or spreading for a longer time. The study will test three different treatments: a combination of olaparib (Lynparza®) and durvalumab (IMFINZI®), a vaccine called UV1 with durvalumab, or just durvalumab on its own. Researchers want to compare how well these treatments work by looking at how long patients live without their cancer getting worse, and by checking their overall health and quality of life. This is a Phase II trial, meaning it's an early-stage study to see if these treatments are safe and effective enough to be studied in larger trials.
At a glance
What is this study about?
This study is an important step in finding better treatments for women with ovarian cancer that has come back after initial treatment. Sometimes, despite successful initial treatment, ovarian cancer can return. For many women, their cancer does not have a specific change in the BRCA gene, which is a common target for some existing treatments. This study is specifically designed for these women.
The main goal of this research is to see if combining certain new medications can stop the cancer from growing for a longer time than current approaches. The treatments being tested include olaparib (known as Lynparza®), which targets cancer cells' ability to repair themselves; durvalumab (known as IMFINZI®), an immunotherapy that helps your body's immune system fight the cancer; and UV1, which is a type of vaccine designed to activate your immune system against cancer cells. By combining these, researchers hope to find more effective ways to manage the disease.
Ultimately, the study aims to improve how long patients live comfortably without their cancer getting worse, and to assess their overall well-being during treatment. The information gathered will help doctors understand if these new combinations are promising for future, larger studies and, eventually, for broader use to help women with recurrent ovarian cancer.
Key takeaways
- This study is for women with advanced ovarian cancer that has returned.
- It focuses on cancers that don't have a specific BRCA gene change.
- It's testing combinations of new drugs and a vaccine to see if they can control cancer growth.
- The main aim is to see if these treatments can keep the cancer from growing for longer.
- Participation involves receiving specific study treatments and regular check-ups.
Who may be eligible?
To be considered for this study, you must be a woman aged 18 or older. Your doctors will have diagnosed you with ovarian cancer that has come back after previous treatment, and it will have been determined that your cancer does not have a specific change in the BRCA gene.
There will also be other health checks to ensure the study treatments are safe for you. For example, your general health, blood test results, and how well your organs are working will be carefully reviewed. This helps make sure you can safely participate and that the study results are reliable.
It's important to remember that even if you meet these general criteria, the study team will need to conduct a thorough review of your medical history to confirm if this particular study is the right fit for you.
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.
- I am 18 years old or older.
- I have been diagnosed with ovarian cancer that has come back.
- Tests have shown my cancer does not have a BRCA gene mutation.
What does participation involve?
If you decide to join this study, you will be assigned to one of three treatment groups by chance, like flipping a coin. You won't be able to choose your treatment group. You will receive one of the study treatments – either a combination of olaparib (a daily pill) and durvalumab (given as an infusion into a vein), durvalumab combined with the UV1 vaccine (injections), or durvalumab on its own. Durvalumab is given as an infusion, and UV1 is given as injections. You'll likely have regular hospital visits for these treatments and for check-ups, which will include blood tests, scans, and discussions about how you're feeling.
The study will carefully follow your health and any side effects. You'll also be asked about your quality of life. The main part of the treatment will continue for a period, followed by regular check-ups to monitor your health and the cancer, even after you stop taking the study medication. The total time you're followed in the study could be several years.
Potential risks and benefits
Locations (9)
- —UnverifiedNetherlands
- —UnverifiedFinland
- —UnverifiedNorway
- —UnverifiedLithuania
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedBelgium
- —UnverifiedDenmark
Common questions
What does 'recurrent ovarian cancer' mean?
This means your ovarian cancer has come back after you've already had treatment for it.
What does 'BRCAwt' mean?
It means your cancer does not have a specific change (mutation) in the BRCA gene.
Are these new treatments or available in the UK?
Some of these drugs are approved for other conditions or types of cancer, but their use in these specific combinations for recurrent ovarian cancer without a BRCA mutation is being studied for the first time.
Will I know which treatment I'm getting?
No, you will be randomly assigned to one of the treatment groups, like drawing lots, and you won't know which one you are receiving.
How long will I be in the study?
The treatment phase length will vary, but you will be followed for several years to track your health and the cancer's progress.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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