Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

EPIK-O: A Phase III, multi-center, randomized (1:1), open-label, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single agent cytotoxic chemotherapy, in participants with no germline BRCA mutation detected, platinum-resistant or refractory, high-grade serous ovarian cancer

This research study, called EPIK-O, is for women with advanced ovarian cancer that hasn't responded well to platinum-based chemotherapy or has returned. This is a specific type called high-grade serous ovarian cancer, and participants must not have a certain genetic change (BRCA mutation) passed down from their family. The study aims to find out if combining two new drugs, alpelisib and olaparib, is more effective and safer than standard chemotherapy treatments like paclitaxel or doxorubicin. Researchers will track how long participants live without their cancer getting worse, alongside other measures of health, side effects, and quality of life. This is a large-scale study, meaning it's in a late stage of testing.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novartis Pharma AG

Enrolment target

Start

28 May 2024

Platinum-resistant or refractory high-grade serous ovarian cancer with no germline BRCA mutation

What is this study about?

This study is called EPIK-O and it's looking into new ways to treat a specific type of ovarian cancer. Ovarian cancer affects a woman's ovaries, and this study focuses on a type called high-grade serous ovarian cancer that has become resistant to or has returned after previous chemotherapy that used platinum-based drugs. Importantly, the study is for women who don't have a specific inherited genetic change called a BRCA mutation, which some ovarian cancer patients have.

The main aim of this research is to see if a combination of two drugs, alpelisib and olaparib, works better than current chemotherapy treatments. The chemotherapy drugs used as a comparison in this study are paclitaxel or doxorubicin. The researchers want to find out if the new combination can help control the cancer for longer and if it's safe to use.

They will be very carefully checking how long people live without their cancer getting worse after starting treatment. They will also look at whether the cancer shrinks, how long any improvements last, and how long it takes for a person's general health and ability to do daily activities to change. Safety is a big focus too, so they will be monitoring any side effects and how well people tolerate the treatment, looking at things like hospital visits, blood test results, and how the heart, kidneys, and liver are working. They'll also ask about your quality of life.

Key takeaways

This study is for women with a specific type of advanced ovarian cancer.
It's for cancer that has resisted or returned after platinum chemotherapy.
Participants must not have an inherited BRCA gene mutation.
It compares two new drugs together against standard chemotherapy.
The study will check how well the treatment works and its safety.
You have the option to leave the study at any time.

Who may be eligible?

This study is for women who are 18 years old or older. You would be considered if you have a specific type of ovarian cancer called high-grade serous ovarian cancer. This means your cancer has either come back or gotten worse after you've already had chemotherapy that included a platinum-based drug. It's important that your cancer is considered 'platinum-resistant' or 'platinum-refractory', meaning it hasn't responded well to that type of treatment.

Crucially, you must not have an inherited BRCA gene mutation. This means that tests have shown you don't carry a specific gene change that some people with ovarian cancer have. This study is specifically for those without this particular genetic make-up.

There will be other detailed medical checks to make sure your general health is suitable for taking part in a clinical trial. These are in place to keep you safe and ensure the study results are clear.

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 female and 18 years old or older?
Do you have high-grade serous ovarian cancer?
Has your cancer returned or progressed within six months after platinum-based chemotherapy?
Have tests shown you do not have an inherited BRCA gene mutation?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be assigned by chance (like flipping a coin) to receive either the combination of alpelisib and olaparib or one of the standard chemotherapy options (paclitaxel or doxorubicin). You will have regular visits to the hospital or clinic, which will include physical examinations, blood tests, and scans (like CT or MRI) to check how the treatment is working and monitor your health. These assessments will be done over time to track your progress.

The drugs will be given according to a specific schedule, which your doctor and the study team will explain in detail. You will be monitored closely for any side effects. After your main treatment phase, there will be follow-up appointments to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation could vary, continuing as long as the treatment is helping you and you are tolerating it well, followed by a period of regular check-ups.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could be more effective than standard options, or it might help researchers learn more about your type of cancer. However, the new drugs might not work for you, or they could cause side effects that are unexpected or more severe than standard treatments. While the study team will do everything to monitor your safety, like all medications, there's always a risk of side effects. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Finland
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Unverified
Spain

Common questions

What is 'platinum-resistant ovarian cancer'?

This means your ovarian cancer has either come back or continued to grow within six months after you finished chemotherapy treatment that included a drug like carboplatin or cisplatin.

What does 'no germline BRCA mutation' mean?

This means that tests have shown you do not have a specific inherited change in your BRCA gene that makes you more likely to get certain cancers. This study is specifically for women without this particular genetic alteration.

Are alpelisib and olaparib chemotherapy drugs?

No, they work differently from traditional chemotherapy. Olaparib is a type of drug called a PARP inhibitor, which targets cancer cells' ability to repair themselves. Alpelisib is a PI3K inhibitor, which blocks a different pathway that can help cancer grow.

Will I know which treatment I am receiving?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving (either the drug combination or standard chemotherapy).

What is a 'Phase III' study?

Phase III means this is a late-stage study. The new treatments have already been tested in earlier phases and shown some promise. This phase aims to confirm if they are more effective and safer than existing treatments for a larger group of people.