Avelumab Short Maintenance Trial
This research study, called the Avelumab Short Maintenance Trial, is investigating a medicine called Bavencio, specifically for people with a type of bladder cancer known as urothelial cancer. Researchers want to find out if giving Bavencio after standard chemotherapy helps patients live longer, especially looking at a new goal of 18 months or more. They are also checking how well the treatment works in different groups of people, for example, depending on specific features of their cancer or if the cancer has spread. This is a large, later-stage study (Phase III and Phase IV), meaning the medicine has already been tested to some extent and researchers are now gathering more detailed information about its effectiveness and safety.
At a glance
What is this study about?
This study is called the Avelumab Short Maintenance Trial and it's looking into a treatment for a type of cancer that affects the bladder, called urothelial cancer. Sometimes, this cancer can be quite serious, spreading into the bladder muscle or other parts of the body. The specific medicine being tested is called Bavencio.
The main aim of this study is to see if patients who receive Bavencio live longer, specifically checking if they reach 18 months or more of overall survival. This is a really important goal because it helps doctors understand if the treatment can effectively extend someone's life. Researchers are also interested in seeing how Bavencio works in different situations, for example, whether it works better for people whose cancer has certain features or for those whose cancer has spread to particular areas of the body. They’re also checking how long it takes for the cancer to grow or come back (this is called progression-free survival) and how many people see their cancer shrink or disappear.
This study is in a combined Phase III and Phase IV stage. This means that Bavencio has already undergone earlier testing to show it's generally safe and has some effect. Now, researchers are looking for more definite proof of its benefits, particularly in a larger group of patients, and gathering even more information about its long-term effects and any side effects. The hope is that this study will provide crucial information to help improve treatment options for people with urothelial cancer.
Key takeaways
- The study tests a medicine called Bavencio for bladder cancer.
- It aims to see if patients live longer (at least 18 months or more).
- It’s a late-stage study (Phase III and IV), gathering more detailed information.
- The treatment is given as a drip (infusion).
- Researchers are looking at various ways the treatment might help different patients.
Who may be eligible?
To be part of this study, you need to be an adult, at least 18 years old. There is no upper age limit, so people of all adult ages can be considered. The study is open to everyone, regardless of whether you are male or female.
Your doctors will check your medical history to make sure that taking part in the study would be safe and appropriate for you. This means they will look at your specific diagnosis of urothelial cancer and confirm it meets the study’s requirements. They will also need to make sure you generally meet the health criteria to receive the study medication safely.
- Are you 18 years old or older?
- Do you have urothelial cancer (a type of bladder cancer)?
- Are you able to attend regular hospital/clinic appointments?
- Are you comfortable with receiving medication as an infusion (drip)?
- Are you willing to have health checks and tests throughout the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the medication Bavencio, given as a drip into your arm (an infusion). The study will closely monitor your health and how you respond to the treatment over time. You would have regular visits to the hospital or clinic for these infusions and for various tests, such as blood tests and scans, to see how the cancer is reacting and to check for any side effects. These visits would happen regularly throughout the study period. The exact number of visits and tests would be explained to you by the study team. You would also have follow-up appointments after you finish receiving the medication to track your long-term health. The total duration of your participation could vary, but the study is specifically looking at outcomes over an 18-month period or more.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What type of cancer is this study for?
This study is for people with urothelial cancer, which is a type of bladder cancer. It includes muscle invasive bladder cancer.
What is Bavencio?
Bavencio (also known as Avelumab) is a medicine that is given as a drip. It is being studied to see its effects on bladder cancer.
What does '18 months overall survival' mean?
This refers to whether people receiving the treatment live for 18 months or longer after starting the study. It's a key measure of how well the treatment works.
Are there different groups of patients in this study?
Yes, researchers are looking at how the treatment works for different groups, for example, based on specific features of their cancer or if the cancer has spread to certain areas.
Can women participate in this study?
Yes, the study is open to all adults, regardless of their gender.
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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