An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
This research study, called EV-301, is exploring a new treatment called enfortumab vedotin for people with advanced bladder or urinary tract cancer that has either spread to other parts of the body or cannot be removed by surgery. These individuals have already received previous treatments. The study aims to find out if enfortumab vedotin is more effective than standard chemotherapy (vinflunine, docetaxel, or paclitaxel) at helping people live longer. Researchers will also look at how the treatment affects the cancer's growth, how long people feel well, any side effects, and their overall quality of life. Participants will be randomly assigned to receive either the new drug or one of the standard chemotherapy options.
At a glance
What is this study about?
This study is particularly important for people with advanced urothelial cancer, which is a type of cancer that starts in the cells lining the bladder and other parts of the urinary system. When this cancer has spread or is too advanced for surgery, it can be very challenging to treat. The study is testing a new drug called enfortumab vedotin against existing chemotherapy treatments. The main goal is to see if enfortumab vedotin helps people live longer than current treatments.
Beyond simply extending life, the researchers are also keen to understand other aspects of treatment. This includes how well the new drug shrinks or controls the cancer, how long it takes for the cancer to show signs of growing again, and what side effects people might experience. They will also carefully monitor participants' overall health, including vital signs and general well-being.
Crucially, this study also focuses on quality of life. This means that as well as medical measurements, the research team will ask participants about their physical, emotional, and social health through questionnaires. This helps to get a complete picture of how the treatment impacts daily life, which is very important for patients and their families.
Key takeaways
- This study is for advanced bladder/urinary tract cancer.
- It compares a new drug (enfortumab vedotin) to standard chemotherapy.
- The main goal is to see if the new drug helps people live longer.
- It also checks for side effects and impacts on quality of life.
- Participants will be randomly assigned to one of two treatment groups.
- Close medical monitoring is part of taking part.
Who may be eligible?
To join this study, you must be at least 18 years old. There's no upper age limit, meaning older adults are welcome to participate if they meet other criteria. The study welcomes both men and women.
Key to joining is having locally advanced or metastatic urothelial cancer, which means the cancer has either spread beyond its original location or to distant parts of the body. You must have already received some previous treatment for this type of cancer.
There will be other detailed medical checks to make sure the study treatment is safe and appropriate for you. Your doctor will be able to explain all the specific requirements and help determine if you are suitable for this research.
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 advanced urothelial cancer (bladder or urinary tract cancer)?
- Has your cancer spread to other parts of your body or is it too advanced for surgery?
- Have you already received some previous treatment for this cancer?
- Are you able to attend regular clinic appointments and follow study procedures?
What does participation involve?
If you decide to take part in this study, you'll be randomly assigned to one of two groups: one receiving enfortumab vedotin, and the other receiving standard chemotherapy (vinflunine, docetaxel, or paclitaxel). This means you won't get to choose which treatment you receive. You'll have regular visits to the clinic for treatment, monitoring, blood tests, and scans to check how you're responding. These visits will be more frequent at the beginning and then become less frequent over time.
You'll also be asked to complete questionnaires about your quality of life. Throughout the study, the research team will carefully monitor any side effects you might experience. The total duration of your participation, including follow-up after treatment, will depend on how you respond to the treatment and the study's overall timeline, but it can continue for several months or even longer.
Potential risks and benefits
Locations (2)
- —UnverifiedPortugal
- —UnverifiedSpain
Common questions
What is urothelial cancer?
Urothelial cancer is a type of cancer that starts in the cells lining the bladder, kidneys, or other parts of the urinary system.
What does 'locally advanced or metastatic' mean?
This means the cancer has either grown outside of where it started but hasn't spread far, or it has spread to other parts of the body.
What is enfortumab vedotin?
It's a new type of drug being tested that specifically targets cancer cells while trying to limit harm to healthy cells.
Will I know which treatment I'm getting?
No, you will be randomly assigned to either the new drug or standard chemotherapy. It's like flipping a coin to ensure fairness.
What is 'quality of life' in a study?
It refers to how treatment affects your daily well-being, mood, energy levels, and ability to do normal activities, measured through questionnaires.
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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