A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
This research studied a new medicine called sasanlimab for people with early-stage bladder cancer that hasn't grown into the bladder muscle. This type of cancer is called non-muscle invasive bladder cancer. The study wanted to find out how safe sasanlimab is and how well it works, either on its own or with a standard treatment called BCG (Bacillus Calmette-Guerin). Participants had their bladder cancer removed by surgery and were considered at high risk of it returning. The study had different groups: some received sasanlimab and BCG, while others received BCG only. One part of the study focused on people whose cancer hadn't responded well to previous BCG treatment. Please note that one section of the study (Part B) stopped accepting new participants in August 2022, but this was not due to safety concerns.
At a glance
What is this study about?
This study, called CREST, is investigating a new medicine called sasanlimab for people who have bladder cancer that hasn't spread into the bladder muscle. This type of cancer is often called non-muscle invasive bladder cancer (NMIBC). The main goal of this research is to see if sasanlimab, either on its own or combined with a standard treatment called BCG (Bacillus Calmette-Guerin), can help stop the cancer from coming back.
The study was set up in two main parts. Part A looked at people whose bladder cancer was newly diagnosed as high-risk and hadn't been treated with BCG before. These participants were split into three groups: one received sasanlimab and BCG for a longer period, another received sasanlimab and BCG for a shorter period, and the third group only received BCG. Part B looked at people whose bladder cancer hadn't responded well to previous BCG treatment. Here, participants would have received sasanlimab. However, new participants are no longer being accepted for Part B of this study, a decision made in August 2022 that was not related to safety worries.
Ultimately, researchers want to see if adding sasanlimab to treatment can keep people free from cancer for longer compared to BCG alone. They are also looking at how often the cancer completely disappears with sasanlimab in people whose cancer hasn't responded to BCG. Understanding these outcomes will help doctors decide if sasanlimab could be a good treatment option for certain types of early bladder cancer.
Key takeaways
- The study tests a new medicine, sasanlimab, for early-stage bladder cancer.
- It aims to see if sasanlimab helps prevent cancer from returning, alone or with standard treatments.
- Participants had early bladder cancer that hadn't spread and was considered high-risk.
- An earlier part of the study (Part B) for BCG-unresponsive cancer is now closed to new participants.
- The decision to close Part B was not due to safety worries.
- The study explores if sasanlimab improves long-term outcomes for patients.
Who may be eligible?
To join this study, your doctor would first need to check if you meet certain requirements. Generally, you would need to have a specific type of early-stage bladder cancer that hasn't spread into the bladder muscle and has been confirmed by a doctor. All visible cancer would need to have been recently removed by surgery.
If your cancer had not responded well to previous BCG treatment, you might have been considered for one part of the study (though this part is no longer taking new participants). A key point is that you should either have refused or be unable to have an operation to remove your bladder (called a radical cystectomy).
There are also reasons why you wouldn't be able to join. For example, if your bladder cancer has spread into the muscle or to other parts of your body, or if you've already had certain types of immunotherapy or radiation treatment to your bladder, you wouldn't be eligible. Also, if you received BCG treatment within the last two years (for Part A of the study), you wouldn't qualify. Your doctor will be able to discuss all these details 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.
- Do you have early bladder cancer that has not spread into the bladder muscle?
- Has all your bladder cancer been removed by surgery recently?
- Have you been told you are unable to have or have refused surgery to remove your bladder?
- Have you NOT had certain immunotherapies or radiation to your bladder before?
- Have you NOT had other types of urothelial cancer that have spread?
- Have you NOT had BCG treatment within the last two years (for Part A of the study)?
What does participation involve?
Taking part in a study like this typically involves regular visits to the study clinic. During these visits, you would receive the study medicine, sasanlimab, which is given as an injection under the skin (subcutaneous), and potentially BCG, which is given into the bladder (intravesical). Doctors and nurses would carefully monitor your health and check for any side effects. You would also have physical examinations, blood tests, and scans or procedures like cystoscopies to check your bladder and see how the cancer is responding.
The exact number and frequency of visits, as well as the total length of your participation, would depend on which treatment group you are in and how your body responds. There would be an initial treatment period, often followed by a period where treatment might be given less frequently, and then a follow-up period to continue monitoring your health and the cancer. All these details would be fully explained to you before you decide to join.
Potential risks and benefits
Locations (194)
- Arizona Urology SpecialistsVerified postcodeTucson, United States
- Arkansas UrologyVerified postcodeLittle Rock, United States
- Koman Family Outpatient PavilionVerified postcodeLa Jolla, United States
- Sulpizio Cardiovascular Center at UC San Diego HealthVerified postcodeLa Jolla, United States
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)Verified postcodeLa Jolla, United States
- UC San Diego Moores Cancer CenterVerified postcodeLa Jolla, United States
- University of California Irvine Medical CenterVerified postcodeOrange, United States
- UC San Diego Medical Center - HillcrestVerified postcodeSan Diego, United States
- The Urology Center of ColoradoVerified postcodeDenver, United States
- Urological Research Network CorpVerified postcodeHialeah, United States
- UF Health JacksonvilleVerified postcodeJacksonville, United States
- UF Health NorthVerified postcodeJacksonville, United States
Common questions
What is non-muscle invasive bladder cancer?
It's an early form of bladder cancer where the cancer cells are only in the lining of the bladder and haven't grown into the deeper muscle layer.
What is BCG?
BCG (Bacillus Calmette-Guerin) is a common treatment for early bladder cancer. It's a type of immunotherapy given directly into the bladder to help your immune system fight the cancer.
What is sasanlimab?
Sasanlimab is a new investigational medicine that aims to boost your body's immune system to recognise and fight cancer cells. It's given as an injection.
Can I still join this study?
The part of the study for people whose cancer hadn't responded to previous BCG treatment (Part B) is no longer accepting new participants. Your doctor can tell you if any other parts of the study are still open or if similar studies are available.
Why did they stop taking new patients for Part B?
The study organisers decided to stop taking new participants for Part B in August 2022. This decision was not made because of safety concerns with the medicine.
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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