AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
This study is for women with advanced ovarian cancer that has returned or grown after platinum-based chemotherapy. We are testing a new drug called AZD5335. This cancer treatment aims to stop the cancer from growing. The study will compare AZD5335 to standard treatments already available. Participants will be grouped based on a special marker found on their cancer called FRα. Some will receive AZD5335, while others will receive either mirvetuximab soravtansine or another type of chemotherapy, depending on their FRα level. The main goal is to see if AZD5335 can keep the cancer under control for longer than current treatments. This is a Phase 3 study, meaning it is a late-stage trial trying to confirm if a new treatment is better than existing ones.
At a glance
What is this study about?
This research study is about finding better treatments for a type of cancer called ovarian cancer, specifically when it has become 'platinum-resistant'. This means the cancer has come back or is growing after initial chemotherapy treatments that included a drug called platinum. This can be a challenging situation, and doctors are always looking for new ways to help patients.
In this study, we are investigating a new medication called AZD5335. This drug is designed to attack cancer cells in a specific way. We want to see if AZD5335 is better at stopping the cancer from growing or spreading compared to the treatments currently available. The study is divided into two main groups based on a specific 'marker' that can be found on some ovarian cancer cells, called FRα. This helps researchers understand if AZD5335 works differently for different types of ovarian cancer.
Participants will be randomly assigned to receive either AZD5335 or a standard treatment. These standard treatments might include mirvetuximab soravtansine (if their cancer has high levels of the FRα marker) or various types of chemotherapy (if their cancer has low levels of the FRα marker). By comparing these treatments, the study aims to discover if AZD5335 can offer a new and more effective option for women living with platinum-resistant ovarian cancer.
Key takeaways
- New study for women with platinum-resistant ovarian cancer.
- Compares a new drug (AZD5335) to standard treatments.
- Participants will be randomly assigned to different treatments.
- Regular health checks and scans will monitor cancer progress.
- Aims to find out if AZD5335 keeps cancer under control for longer.
- You can stop participating at any time.
Who may be eligible?
This study is looking for women aged 18 or older who have a specific type of ovarian, fallopian tube, or primary peritoneal cancer. The cancer needs to be 'high-grade serous', and importantly, it must be 'platinum-resistant'. This means your cancer has come back or grown within six months of your last platinum-based chemotherapy.
To join, you must have had between one and three previous lines of cancer treatment. If you have a BRCA gene change, you should have already received a specific type of drug called a PARP inhibitor, unless there's a good medical reason why you couldn't. Also, the study will need a sample of your tumour tissue to check specific markers.
There are also some reasons why you might not be able to join. For instance, if you have certain types of ovarian cancer (like endometrioid or clear cell), or if your cancer is 'platinum-refractory' (meaning it grew very quickly after your first platinum chemotherapy). People with certain eye conditions, bowel problems, or lung conditions that are not caused by infection would also not be able to take part.
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 18 years old or older?
- Do you have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer?
- Has your cancer started to grow again within 6 months of your last platinum-based chemotherapy?
- Have you had between 1 and 3 previous lines of anti-cancer treatment?
- Are you able to provide a sample of your tumour tissue?
What does participation involve?
If you join this study, you might receive the new drug AZD5335, or you might receive one of the standard treatments for your cancer, such as mirvetuximab soravtansine or another chemotherapy. This will be decided by chance, like flipping a coin, after your cancer's FRα level has been checked. You will take the assigned treatment regularly, as directed by the study team.
You will have regular check-ups and scans to monitor how your cancer is responding to the treatment. These scans, typically CT or MRI, will help doctors see if your tumour is shrinking or growing. You will continue with the study treatment until your cancer starts to grow again, or if you experience side effects that make it necessary to stop, or for other medical reasons. Even after stopping the study treatment, the research team will continue to follow your health to see how you are doing in the long term, especially to track your overall survival. An independent group of experts will regularly check the study's safety and results to make sure participants are safe and the study is run correctly.
Potential risks and benefits
Locations (125)
- Research SiteVerified postcodeFort Lauderdale, United States· Not yet recruiting
- Research SiteVerified postcodeJupiter, United States· Recruiting
- Research SiteVerified postcodeEvanston, United States· Not yet recruiting
- Research SiteVerified postcodePeoria, United States· Not yet recruiting
- Research SiteVerified postcodeUrbana, United States· Not yet recruiting
- Research SiteVerified postcodeTowson, United States· Not yet recruiting
- Research SiteVerified postcodeBurlington, United States· Not yet recruiting
- Research SiteVerified postcodeWorcester, United States· Not yet recruiting
- Research SiteVerified postcodeMinneapolis, United States· Not yet recruiting
- Research SiteVerified postcodeOmaha, United States· Not yet recruiting
- Research SiteVerified postcodeLas Vegas, United States· Not yet recruiting
- Research SiteVerified postcodeThe Bronx, United States· Not yet recruiting
Common questions
What does 'platinum-resistant' mean?
It means your ovarian cancer has started to grow again within six months after you finished a chemotherapy treatment containing a drug called platinum.
What is AZD5335?
AZD5335 is a new investigational drug being tested in this study to see if it can help control the growth of ovarian cancer that has become resistant to standard chemotherapy.
Will I definitely get the new drug AZD5335?
No, you will be randomly assigned to receive either AZD5335 or a standard treatment for your type of cancer. This is like flipping a coin, so it's a 50/50 chance.
How long will I be in the study?
You'll be on the study treatment until your cancer grows, or if side effects make it necessary to stop. After that, your health will still be monitored for a longer period to see how you are doing.
What are the common side effects?
The specific side effects of AZD5335 are still being studied. The research team will explain all known potential side effects and monitor you closely throughout the study.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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