Conditions
Carcinoma In Situ, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
Trial Purpose
Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the centre of the bladder.
The standard treatment for HR NMIBC is a procedure to remove the tumour called transurethral resection of the bladder tumour (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding V940, the study treatment, to standard treatment can help treat HR NMIBC. V940 is designed to help a person’s immune system attack their specific cancer.
The goals of this study are to learn:
* If people who receive V940 with BCG live longer without the cancer growing, spreading or coming back, or dying from any cause, compared to people who receive BCG alone
* If more people who receive V940 with BCG have their cancer go away (complete response), compared to people who receive BCG alone
* How many people who receive V940 without BCG have their cancer go away
NATIONAL TRIAL REFERENCE NUMBER
NCT06833073
EU CT
2024-517335-46-00
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
All ages
Sex
All
About The Trial
Trial Phase
Trial Phase 2
Tests the medicine or vaccine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy.
Trial start and end dates
- Actual study start date 11 March 2025
- Estimated primary completion date 3 September 2031
- Estimated study completion date 3 September 2031
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about