A PHASE 2, OPEN-LABEL, RANDOMIZED, NON-COMPARATIVE CLINICAL TRIAL OF ADP-A2M4CD8 MONOTHERAPY AND IN COMBINATION WITH NIVOLUMAB IN SUBJECTS WITH RECURRENT OVARIAN CANCERS (SURPASS-3 STUDY/ GOG-3084)
This Phase 2 clinical trial is exploring a new treatment approach for women with ovarian cancer that has returned after prior therapy. The trial tests an innovative cell therapy called ADP-A2M4CD8, either on its own or combined with an immunotherapy drug called nivolumab (Opdivo). Cell therapy works by taking some of your own immune cells (T-cells), genetically modifying them in a laboratory to spot a specific protein on cancer cells called MAGE-A4, and then returning them to your body to fight the cancer. Nivolumab is an established medicine that helps immune cells stay active against tumours. The main aim of the trial is to see whether these treatments can shrink tumours or clear them completely, and how long that benefit lasts. The study will also closely monitor safety and any side effects to protect participants.
At a glance
What is this study about?
Ovarian cancer can sometimes return after initial surgery and chemotherapy. When this happens, it is called recurrent ovarian cancer, and finding effective new ways to manage the disease becomes very important. This clinical trial is testing an experimental approach called T-cell receptor therapy, which uses your body's own immune system to target cancer cells.
In this study, doctors collect some of your immune cells, known as T-cells, from your blood. In a specialist laboratory, these cells are reprogrammed to recognise a specific marker found on certain ovarian cancer cells, known as MAGE-A4. Once the cells are ready, they are given back to you through a drip so they can seek out and attack the cancer cells. This modified cell therapy is called ADP-A2M4CD8.
Participants in this study receive either ADP-A2M4CD8 on its own, or alongside an immunotherapy drug called nivolumab. Nivolumab works by stopping cancer cells from switching off your immune system. By combining these treatments, scientists hope to give the modified immune cells the best possible chance to shrink tumours and keep the cancer under control for longer.
Key takeaways
- Phase 2 clinical trial testing an innovative immune cell therapy for recurrent ovarian cancer.
- Compares the cell therapy alone against cell therapy combined with nivolumab.
- Requires your cancer to have the MAGE-A4 protein and your body to have the HLA-A2 tissue type.
- Mainly designed to see how well and how safely the treatment can shrink tumours.
- Participation is completely voluntary and requires regular hospital visits and monitoring.
Who may be eligible?
This trial is for adult women aged 18 and over who have been diagnosed with ovarian cancer that has returned after earlier treatment.
Because this is a targeted therapy, your cancer cells must have a specific protein called MAGE-A4, and you must have a common genetic tissue type known as HLA-A2. The study team can check for both of these using a routine blood sample and a sample of your previously stored tumour tissue.
You will also need to be well enough to undergo the treatment, with reasonably good heart, kidney, and liver function. Your doctor or the study team will carry out standard health checks to confirm whether this trial is safe and suitable 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 female aged 18 or older.
- I have been diagnosed with ovarian cancer that has returned.
- I am willing to have my tumour tissue and blood tested for specific markers (MAGE-A4 and HLA-A2).
- I am generally well enough to travel to hospital visits and undergo scans and blood tests.
- I am interested in exploring an experimental immune cell therapy.
What does participation involve?
Taking part in this study involves several stages over a number of months. First, you will have screening tests, including blood tests and scans, to confirm your eligibility. If you are accepted, doctors will collect your T-cells through a blood-filtering process called apheresis. While your cells are being modified in the laboratory, you may receive standard treatment to keep your cancer stable.
Before receiving your modified cells, you will have a short course of chemotherapy to clear space in your immune system. You will then receive the cell infusion in hospital, where you may need to stay for a short period so the medical team can monitor you closely for any reactions. If you are in the combination group, you will also receive nivolumab as regular infusions. Following treatment, you will attend regular hospital appointments for scans, blood tests, and health reviews for several months to track how well the treatment is working.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is T-cell therapy?
It is a type of treatment that uses your own immune cells. Doctors collect them, train them in a lab to recognise cancer cells, and give them back to you to fight the disease.
Will I have to stay in hospital?
Yes, you will likely need to stay in hospital for a short time after receiving your cells so the team can monitor you closely and manage any side effects.
How do I know if I have the MAGE-A4 protein?
The study team will test a small sample of your tumour tissue, usually from a previous biopsy or surgery, to find out.
Can I leave the study if I change my mind?
Yes. You are free to stop taking part at any point. Leaving the study will not affect the quality of your regular medical care.
Will I have to pay for the study treatment?
No. The trial medicine and all study-related tests are provided free of charge, and some travel expenses may also be covered.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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