An open label, single-arm, phase 2 study of neoadjuvant sacituzumab govitecan, before radical cystectomy, for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-based chemotherapy
This study is for people who have bladder cancer that has grown into the muscle. This specific type of bladder cancer is called 'muscle-invasive bladder cancer'. The study is looking at a new treatment called Trodelvy (sacituzumab govitecan) given before surgery. It's for patients who either can't have or prefer not to have the usual chemotherapy treatment. The main goal is to find out how many people have no live cancer cells left in their bladder after surgery, following treatment with Trodelvy. Researchers will also be checking for any side effects and how safe the treatment is. This is a Phase II study, which means it’s still an early look at this treatment, but it has shown some promise already.
At a glance
What is this study about?
This study is investigating a new treatment called Trodelvy for a serious type of bladder cancer. This cancer is called 'muscle-invasive bladder cancer' because it has grown into the muscle layer of the bladder wall. If you or someone you know has this type of cancer, doctors usually recommend surgery to remove the bladder (called a radical cystectomy), often after a course of chemotherapy. However, some people can't have or choose not to have chemotherapy, perhaps due to other health conditions or personal preferences. This study is specifically for those individuals.
The main aim of this study is to see if Trodelvy can effectively shrink or completely get rid of the cancer before surgery. The researchers will be carefully examining the removed bladder tissue after surgery to see if there are any remaining live cancer cells. This is important because if the cancer is completely gone, it may lead to better long-term outcomes.
Beyond simply checking if the cancer is gone, the study will also keep a close eye on how safe Trodelvy is. This involves tracking any possible side effects or unwanted reactions patients might experience. By understanding both its effectiveness and safety, doctors can learn more about whether Trodelvy could be a good treatment option for certain patients with muscle-invasive bladder cancer in the future.
Key takeaways
- This study evaluates Trodelvy for muscle-invasive bladder cancer.
- It's for people who can't get standard chemotherapy before surgery.
- The main goal is to see if Trodelvy clears cancer before bladder removal.
- Researchers also closely monitor for any side effects.
- This is a Phase II study, meaning it's still investigating effectiveness and safety.
Who may be eligible?
To be considered for this study, you would generally need to be at least 18 years old. Both men and women can take part. The most important factor is that you have muscle-invasive bladder cancer.
Crucially, this study is specifically designed for people who either cannot have the standard chemotherapy treatment (for example, due to other health issues) or prefer not to have it. Your doctor will help determine if these criteria apply to your specific situation.
There might be other medical conditions or treatments that could affect whether you can join, but your cancer doctor will be able to discuss all the details with you.
- Are you 18 years old or older?
- Do you have bladder cancer that has grown into the muscle?
- Are you unable to have standard chemotherapy, or have you decided not to?
- Are you considering surgery to remove your bladder?
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 will receive the study medicine, Trodelvy, before your planned bladder removal surgery. This medicine is given as an infusion, meaning it goes directly into your bloodstream through a drip, which will happen at the hospital. You will have regular visits to the hospital or clinic for these treatments and for check-ups.
During your time in the study, doctors and nurses will closely monitor your health. This will involve physical examinations, blood and urine tests, and scans to see how you are responding to the treatment and to check for any side effects. You will also have your bladder removal surgery as planned. After your surgery, there will be follow-up appointments to continue monitoring your health and recovery. The total duration of your participation will include the treatment period, the surgery, and ongoing follow-up, which can last for several months or even longer.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is 'muscle-invasive bladder cancer'?
This is a type of bladder cancer where the cancer cells have grown into the muscle layer of the bladder wall.
What does 'neoadjuvant' mean?
'Neoadjuvant' means the treatment is given before the main treatment, which in this case is surgery to remove the bladder.
What is Trodelvy?
Trodelvy is the name of the medicine being tested in this study. It's given as an infusion (through a drip).
Why is this study for people who can't have chemotherapy?
This study aims to find a new treatment option for patients who are unable to receive or choose not to have the standard chemotherapy before surgery, giving them another pathway for care.
What does 'complete pathological response' mean?
This means that when doctors look at the removed bladder tissue under a microscope after surgery, they find no living cancer cells remaining.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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