REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)
This research study, named REFRaME-O1, is looking for women with advanced ovarian cancer (including fallopian tube or primary peritoneal cancers) that has returned after initial treatment and is now resistant to standard platinum chemotherapy. The main goal is to compare a new experimental drug, Luveltamab Tazevibulin, with standard chemotherapy treatments chosen by the doctor. Researchers want to find out if this new drug can shrink the cancer or stop it from growing for longer. They will also be checking how safe the new drug is and what side effects people might experience. If you are 18 or older and a woman with this type of cancer, you might be eligible to take part.
At a glance
What is this study about?
This study is called REFRaME-O1, and it's for women who have advanced ovarian cancer (this includes cancers of the fallopian tube or the lining of the abdomen, known as primary peritoneal cancer). For these women, the cancer has unfortunately come back after previous treatment and no longer responds to a common type of chemotherapy called platinum-based chemotherapy.
The main aim of this study is to test a new treatment called Luveltamab Tazevibulin. This new drug will be compared to standard chemotherapy treatments that doctors usually choose, such as Hycamtin, Taxol, Neulasta, Caelyx, or Gemzar. The researchers want to discover if Luveltamab Tazevibulin is more effective at stopping the cancer from growing or shrinking it, and if it's safe to use.
This is a 'Phase 2/3' study, which means it's a step closer to potentially becoming a widely available treatment. Researchers will carefully watch how long it takes for the cancer to grow or return, how many people's cancers respond, and how patients' general health and quality of life are affected. They will also look at any side effects people experience, to get a full picture of the treatment's benefits and risks.
Key takeaways
- This study is for women with advanced ovarian (or related) cancer that has returned.
- The cancer must be 'platinum-resistant' and have a specific marker called FOLR1.
- It compares a new drug (Luveltamab Tazevibulin) with standard chemotherapy.
- Researchers want to see if the new drug stops cancer growth for longer and is safe.
- Participation involves regular clinic visits for treatment and check-ups.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be an adult woman, 18 years old or older. You need to have advanced ovarian cancer, which also includes cancers of the fallopian tube or the lining of the abdomen (primary peritoneal cancer).
Importantly, your cancer must have returned after previous treatments and be resistant to chemotherapy drugs that contain platinum. Your cancer also needs to have a specific marker called Folate Receptor Alpha (FOLR1) to be considered for this study. The study team will check for this marker.
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 an adult woman, 18 years or older?
- Do you have advanced ovarian, fallopian tube, or primary peritoneal cancer?
- Has your cancer come back after previous treatment and become 'platinum-resistant'?
- Has your cancer been tested and found to have the 'Folate Receptor Alpha (FOLR1)' marker?
What does participation involve?
If you decide to take part, you would receive either the new study drug, Luveltamab Tazevibulin, or one of the standard chemotherapy treatments. These treatments are given as infusions, meaning they go directly into your bloodstream, usually through a drip. You would have regular visits to the hospital or clinic for these treatments and for check-ups. These visits would involve physical exams, blood tests, and scans to see how the treatment is working and to monitor any side effects. You will also be asked about how you are feeling and any symptoms you might have. The total length of your participation would depend on how your body responds to the treatment.
Potential risks and benefits
Locations (9)
- —UnverifiedAustria
- —UnverifiedFinland
- —UnverifiedCzechia
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedIreland
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedBelgium
Common questions
What is 'platinum-resistant' cancer?
This means your ovarian cancer has sadly come back within six months after finishing chemotherapy drugs that contain a substance called platinum, like carboplatin or cisplatin.
What does 'Folate Receptor Alpha (FOLR1)' mean?
This is a specific protein that can be found on the surface of some cancer cells. The new drug in this study is designed to target cells that have this protein.
Will I know if I'm getting the new drug or standard treatment?
Yes, in this study, you and your doctor will know whether you are receiving the new study drug or one of the standard chemotherapy treatments. This is called an "open-label" study.
What are 'endpoints' in a study?
Endpoints are the specific things researchers measure to see if a treatment is working. In this study, they are looking at how long the cancer stays stable or shrinks, and the overall survival.
What are "side effects"?
Side effects are unwanted reactions or problems that can happen as a result of taking a medicine or receiving a treatment. The study team will carefully monitor you for any side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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