A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
This study is for people in the UK with muscle-invasive bladder cancer who are scheduled for surgery (radical cystectomy) but can't have or don't want standard chemotherapy. It’s a Phase 2 trial, meaning it's still in earlier stages of testing. Researchers are looking at two new treatment approaches: a device called TAR-200 (which delivers a drug directly to the bladder) combined with a drug called cetrelimab, or cetrelimab by itself. The main goal is to find out if these experimental treatments can shrink the cancer or make it disappear before surgery. They will also track any side effects and how long people stay cancer-free after treatment.
At a glance
What is this study about?
Imagine you have bladder cancer that has grown into the muscle layer, and you're going to have surgery to remove your bladder. Sometimes, doctors recommend chemotherapy before this surgery to try and shrink the cancer first. However, some people can't have this usual chemotherapy, or they choose not to.
This study is testing new ways to treat this type of bladder cancer for those who can't or won't have the standard pre-surgery chemotherapy. Researchers are using two experimental treatments. One involves a small device called TAR-200, which is designed to deliver medicine right into the bladder. The other treatment is a drug called cetrelimab, which helps your body's immune system fight the cancer. Some participants in the study will receive TAR-200 along with cetrelimab, while others will receive cetrelimab alone.
The main thing the doctors want to find out is how well these treatments work to shrink the cancer or make it disappear completely before surgery. They also want to understand any side effects, how safe the treatments are, and if they help people stay cancer-free for longer. This research is important because it could offer new options for people with this type of bladder cancer.
Key takeaways
- This study is for bladder cancer that has spread into the muscle.
- It tests new treatments before planned bladder removal surgery.
- It's for people who can't have or don't want standard chemotherapy.
- The study looks at how well the treatments shrink cancer.
- Researchers will also track safety and side effects.
- It aims to find new options for this type of bladder cancer.
Who may be eligible?
This study is looking for adults aged 18 or older, both men and women, who have a specific type of bladder cancer. This cancer must have grown into the muscle layer of the bladder.
Crucially, you would be considered for this study if you are already planning to have surgery to remove your bladder (called a radical cystectomy). Also, you must be someone who either cannot have the usual chemotherapy before surgery (perhaps due to other health conditions) or you have decided that you don't want to have that standard chemotherapy.
There will be other detailed medical checks to make sure the study treatments are safe and suitable for you. Your doctor will discuss all these criteria with 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.
- Are you 18 years old or older?
- Do you have bladder cancer that has grown into the muscle?
- Are you scheduled to have your bladder removed (radical cystectomy)?
- Have you been told you can't have standard chemotherapy before surgery, or have you chosen not to have it?
What does participation involve?
If you decide to take part, you would receive one of the experimental treatments before your planned bladder surgery. This might involve regular visits to the clinic for treatments, check-ups, and to monitor your health. You would have exams, blood tests, and scans to see how well the treatment is working and to check for any side effects. After your surgery, doctors would continue to follow your health for a period to see how you are doing long-term. The total length of your participation would depend on the specific treatment plan and follow-up schedule.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is muscle-invasive urothelial carcinoma?
This is a type of bladder cancer that has grown from the inner lining into the muscle wall of the bladder.
What is radical cystectomy?
This is a major surgery where the entire bladder is removed.
What is 'ineligible for platinum-based neoadjuvant chemotherapy' mean?
It means you can't have the standard chemotherapy before surgery, often due to other health issues, or you've decided you don't want it.
What are TAR-200 and cetrelimab?
TAR-200 is a new way to deliver medicine directly into the bladder. Cetrelimab is a drug that helps your immune system fight cancer.
Will I definitely get the new treatments?
Yes, everyone in this study will receive either TAR-200 plus cetrelimab, or cetrelimab alone.
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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