ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)
This study, called SURPASS-3, is looking for women aged 18 to 75 with recurrent ovarian cancer, specifically high-grade serous or endometrioid types. The cancer must also have a specific marker called MAGE-A4. Researchers are testing a new treatment, ADP-A2M4CD8, which uses your own modified cells. They want to see how effective and safe this treatment is, both by itself and when combined with another medication called nivolumab. The main goal is to understand if this new treatment can improve the outcome for patients with this type of ovarian cancer.
At a glance
What is this study about?
This study is designed for women with a specific type of ovarian cancer that has come back. It's called SURPASS-3, and it's looking at a new treatment called ADP-A2M4CD8. This treatment is quite special because it involves taking some of your own immune cells, modifying them in a lab to specifically target your cancer, and then giving them back to you.
The study will test this new cell treatment in two ways: some participants will receive it by itself (this is called monotherapy), and others will receive it alongside another medication called nivolumab. Nivolumab is already used in some cancer treatments and helps your immune system fight cancer more effectively. The aim is to understand if ADP-A2M4CD8 can significantly help fight your cancer, either alone or with nivolumab, and to monitor any side effects.
This kind of study is important because it explores new ways to treat cancer, especially when standard treatments haven't worked as well as hoped or the cancer has returned. The treatments are considered experimental, meaning they are still being carefully studied to see if they are better than existing options and safe for widespread use. Your participation helps advance medical knowledge and could potentially lead to new treatments for others in the future.
Key takeaways
- Targets recurrent ovarian cancer with a specific marker (MAGE-A4).
- Uses your own modified immune cells as treatment.
- Compares the cell therapy alone versus with nivolumab.
- Aims to find new, effective treatments for ovarian cancer.
- Involves detailed health checks and long-term follow-up.
- You can withdraw from the study at any time.
Who may be eligible?
To be able to join this study, you need to be a woman between 18 and 75 years old. You must have a confirmed diagnosis of certain types of ovarian cancer that have returned, specifically high-grade serous or endometrioid. A crucial point is that your cancer must also have a specific marker called MAGE-A4, which the study treatment targets. You'll also need to have areas of your cancer that doctors can measure in scans.
Regarding your past treatments, you must have received at least three cycles of a platinum-based chemotherapy as your first treatment. You can have had up to four previous treatments for your cancer. There are specific rules about how long it's been since your last platinum-based treatment if you've only had one line of therapy.
Before you start, you'll have doctors look at your health carefully to make sure the study treatment is safe for you. You'll also need to agree to all the study rules and procedures, including regular check-ups, and give your permission in writing 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 between 18 and 75 years old?
- Do you have recurrent high-grade serous or endometrioid ovarian cancer?
- Has your doctor tested for the MAGE-A4 marker in your cancer?
- Have you had at least 3 cycles of platinum-based chemotherapy as your first treatment?
- Can your doctors measure your cancer on scans?
- Are you willing to have regular hospital visits and follow-up?
What does participation involve?
If you decide to take part in this study, you'll first have some assessments to make sure you're suitable. This will include blood tests, scans, and possibly other examinations. You'll then undergo a procedure called 'leukapheresis,' where some of your blood is taken to collect specific immune cells for the treatment, and then the rest of your blood is returned to you. These cells will then be sent to a lab to be specially prepared for your treatment.
Before you receive the treatment, you'll likely have some chemotherapy to prepare your body, which helps the new cells work better. You'll then receive the ADP-A2M4CD8 cell treatment, which is given as an infusion, similar to a drip. If you're in the group receiving nivolumab, you'll get that medication too. You'll have regular hospital visits for blood tests, scans, and check-ups to monitor how you're responding to the treatment and to manage any side effects. The study involves long-term follow-up to keep track of your health, even after the main treatment period.
Potential risks and benefits
Locations (23)
- Honor HealthVerified postcodeScottsdale, United States
- City of HopeVerified postcodeDuarte, United States
- Augusta UniversityVerified postcodeAugusta, United States
- Karmanos Cancer InstituteVerified postcodeDetroit, United States
- Rutgers Cancer Institute of NJVerified postcodeNew Brunswick, United States
- Cleveland Clinic FoundationVerified postcodeCleveland, United States
- University of Oklahoma Health Sciences CenterVerified postcodeOklahoma City, United States
- Avera Cancer InstituteVerified postcodeSioux Falls, United States
- Swedish Cancer InstituteVerified postcodeSeattle, United States
- University Health Network (Princess Margaret Cancer Center)Verified postcodeToronto, Canada
- Institut de Cancerologie des Hospices Civils de LyonVerified postcodePierre-Bénite, France
- Centre Leon-BerardVerified postcodeLyon, France
Common questions
What is ADP-A2M4CD8?
It's a new type of treatment that uses your own specially modified immune cells to target and fight your cancer.
What is nivolumab?
Nivolumab is a medication that helps your immune system work better to find and destroy cancer cells.
What does 'recurrent ovarian cancer' mean?
It means your ovarian cancer has come back after previous treatments.
What is MAGE-A4?
MAGE-A4 is a specific protein marker that must be present on your cancer cells for you to be eligible for this study.
Will I definitely get the new treatment?
If you're eligible, you'll receive either the new cell treatment by itself or combined with nivolumab, depending on which group you're assigned to.
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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