Bladder Preservation with Sacituzumab Govitecan + Zimberelimab for MuscleInvasive Bladder cancer in cisplatin-unfit and unwilling for cystectomy patients: phase II trial (preSAVE trial)
This research is testing two new medications, Zimberelimab and Trodelvy, for people with a serious type of bladder cancer called muscle-invasive bladder cancer. This is for adult patients who either aren't healthy enough for surgery (a cystectomy) or prefer not to have one. The main goal is to see if these treatments can help patients live longer without their cancer getting worse, spreading, or needing surgery. We'll also check if the treatments can shrink the cancer and if they are safe to use. This kind of study helps us understand if these drugs could be a good alternative to traditional surgery for some patients.
At a glance
What is this study about?
This study is investigating a new way to treat muscle-invasive bladder cancer. This type of cancer is when the bladder cancer has grown into the muscle layer of the bladder wall. Normally, a major operation called a cystectomy, where the bladder is removed, is often recommended. However, some people might not be well enough for this surgery, or they might choose not to have it.
This research is testing two medications, Zimberelimab and Trodelvy, to see if they can help control the cancer without needing to remove the bladder. The main thing researchers want to find out is whether people treated with these drugs can live longer without the cancer spreading, getting worse, or needing a bladder removal operation. We'll be closely monitoring patients and performing regular checks to see how the treatment is working.
This is a 'Phase II' study, which means we're looking to see if these treatments are effective and safe in a larger group of people after initial smaller studies. We also want to understand if these drugs can shrink the cancer and what role biological markers in blood and tissue might play in predicting who responds best to the treatment. The hope is to find a good treatment option for patients who cannot or do not want to undergo bladder removal surgery.
Key takeaways
- This study is testing new treatments for muscle-invasive bladder cancer.
- It's for adults who can't have or don't want bladder removal surgery.
- The goal is to see if these drugs can control cancer and avoid surgery.
- You will receive two different drug treatments via infusion.
- Participation involves regular clinic visits, blood tests, and scans.
- You can withdraw from the study at any time.
Who may be eligible?
You might be able to take part in this study if you are an adult, aged 18 or over.
This study is for people who have muscle-invasive bladder cancer. This means the cancer has grown into the muscle layer of your bladder. It's specifically for those patients who are considered too unwell to have a big surgery to remove their bladder (called a cystectomy), or for those who have decided they don't want to have that surgery.
More detailed checks will be done by the study team, including reviewing your medical history and current health. Both men and women can join this study.
- Are you 18 years old or older?
- Have you been diagnosed with muscle-invasive bladder cancer?
- Is your doctor saying you are not fit enough for bladder removal surgery (cystectomy)?
- Or, have you chosen not to have bladder removal surgery?
- Are you able to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will receive two medications: Zimberelimab and Trodelvy (given as an infusion). The study will involve regular visits to the clinic for treatments and assessments. These assessments will include physical exams, blood tests, and scans (like CT scans) to check how well the treatment is working and to monitor your overall health. You will also have regular examinations of your bladder (cystoscopy).
Researchers will closely follow your health and the progress of your cancer. The exact number of visits and the total length of your participation will depend on how you respond to the treatment and the study's schedule. This can last for several months, with ongoing follow-up to see how you are doing after treatment.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is muscle-invasive bladder cancer?
It's a type of bladder cancer where the cancer has grown into the muscle layer of the bladder wall, making it a more serious form of the disease.
What is a cystectomy?
It's a major operation where the bladder is completely removed, often used to treat muscle-invasive bladder cancer.
What kind of treatments will I receive?
You will receive two medications, Zimberelimab and Trodelvy, given through a drip (infusion).
How long will I be in the study?
The length of your participation will depend on your response to treatment and the study plan, but it will involve regular visits over several months.
Can I stop participating if I want to?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your future medical care.
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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