Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
This research study is for people with a type of bladder cancer called urothelial cancer that has spread to other parts of the body (metastatic) or cannot be surgically removed. The main goal is to find out how safe and effective a new drug, sacituzumab govitecan, is. Researchers are testing this drug by itself and in combination with other treatments such as pembrolizumab, avelumab, and domvanalimab. They will also be looking at how well established chemotherapy drugs like cisplatin and carboplatin work with these newer treatments. This study aims to offer new treatment options for patients whose cancer has progressed after previous therapies.
At a glance
What is this study about?
This study is about finding better ways to treat a specific type of bladder cancer called urothelial cancer. This is when the cancer has either spread to other parts of the body (known as metastatic cancer) or it's grown so much that doctors can't remove it with surgery. The doctors running this study want to see how well a new drug, called sacituzumab govitecan, works, both on its own and when combined with other medicines.
Urothelial cancer can be very challenging to treat, especially when it has spread. Traditional treatments might include chemotherapy, but sometimes these stop working, or patients can't have them. This study is exploring different combinations of drugs, including some that are already used and some newer ones, to see if they can offer better results for patients. The hope is to find treatments that are both effective at controlling the cancer and as safe as possible.
The study is divided into different groups, called 'cohorts,' to test various drug combinations. Some parts of the study are already set up to test specific combinations, while others are randomised, which means patients would be put into a group by chance, much like flipping a coin. However, one of these randomised groups (Cohort 5) has been stopped. The results from this research will help doctors understand if these new approaches can become standard treatments in the future.
Key takeaways
- The study explores new treatments for advanced urothelial (bladder) cancer.
- It tests sacituzumab govitecan, alone or with other drugs, to assess safety and effectiveness.
- Participation involves regular clinic visits, tests, and receiving study medication.
- Potential benefits include access to new treatments; potential risks include side effects.
- Your eligibility depends on your age, general health, and previous cancer treatments.
- You can withdraw from the study at any time without affecting your future care.
Who may be eligible?
To join this study, people typically need to be at least 18 years old (or 19 in South Korea) and generally well enough to take part. This is often measured by something called an ECOG score of 0 or 1, which means you're able to carry out most daily activities without much difficulty.
You would also need to have healthy kidney and liver function, and your blood counts (like red and white blood cells) should be within a healthy range without needing blood transfusions. Doctors usually expect you to have a life expectancy of at least three months to make sure you can benefit from and complete the study.
Beyond these general requirements, there are specific conditions related to your previous cancer treatment. For example, some parts of the study are for people whose urothelial cancer has returned or worsened after having chemotherapy that included platinum-based drugs (like cisplatin or carboplatin) or after specific immunotherapy treatments. Other parts are for people who couldn't have platinum-based chemotherapy initially or who haven't had it for their advanced cancer.
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 (19 in South Korea)?
- Are you generally well and able to carry out most daily activities?
- Do you have healthy kidney and liver function?
- Has your urothelial cancer spread or cannot be removed by surgery?
- Have you previously had treatment for your cancer that may have included platinum-based chemotherapy or immunotherapy?
- Are you expected to live for at least three more months?
What does participation involve?
If you take part in this study, the doctors and nurses will monitor your health closely. This will involve regular visits to the clinic, where you'll have various tests, such as blood tests, urine tests, and scans, to see how the treatment is working and to check for any side effects. You will receive the study medication (or combination of medications) according to a set schedule, which will be carefully explained to you by the study team.
The exact number and timing of visits will depend on which treatment group you are in and how you respond to the medication, but typically, these studies involve frequent visits initially, becoming less frequent over time. The study will continue for as long as the treatment is beneficial and you are tolerating it well, followed by a period of observation where your health will still be monitored. The total duration of participation varies for each patient, but you would be fully informed of the expected timeline before you start.
Potential risks and benefits
Locations (135)
- The University of Arizona Cancer Center-North CampusVerified postcodeTucson, United States· Recruiting
- USC/Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Withdrawn
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Rocky Mountain Cancer CentersVerified postcodeLittleton, United States· Recruiting
- Smilow Cancer Hospital at Yale-New HavenVerified postcodeNew Haven, United States· Recruiting
- Eastern Connecticut Hematology and Oncology AssociatesVerified postcodeNorwich, United States· Withdrawn
- Mount Sinai Comprehensive Cancer CenterVerified postcodeMiami Beach, United States· Recruiting
- Woodlands Medical Specialists, PAVerified postcodePensacola, United States· Recruiting
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- Winship Cancer Institute, Emory UniversityVerified postcodeAtlanta, United States· Completed
- University of Illinois Cancer CenterVerified postcodeChicago, United States· Recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
Common questions
What is urothelial cancer?
Urothelial cancer is a type of cancer that starts in the cells lining the bladder, ureters (tubes from kidneys to bladder), and urethra (tube from bladder out of body). It's the most common type of bladder cancer.
What does 'metastatic' mean?
'Metastatic' means the cancer has spread from where it started to other parts of the body, such as the bones, lungs, or liver.
What is sacituzumab govitecan?
Sacituzumab govitecan is a type of targeted drug called an antibody-drug conjugate. It's designed to find cancer cells and deliver a chemotherapy-like medicine directly to them, hopefully causing less harm to healthy cells.
What are 'platinum-containing regimens'?
These are chemotherapy treatments that include drugs like cisplatin or carboplatin. They are often used as a standard treatment for many cancers, including urothelial cancer.
Will I definitely get the new drug?
It depends on which treatment group you are placed into. Some groups test sacituzumab govitecan on its own or with other new drugs, while others might compare it to standard treatments or different combinations. Your doctor will discuss this with you before you agree to join.
How to find out more
Gilead Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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