Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Bladder cancer often starts in the inner lining of the bladder without growing into the deeper muscle wall. Even after surgery to remove the tumour, high-risk types can return or spread. This phase II clinical trial is testing a medicine called IMUNO BCG Moreau RJ. BCG is a weakened bacterium that triggers the body's immune system to attack cancer cells. In this study, patients who have had surgery to clear their bladder tumours receive this liquid medicine directly into the bladder using a small tube (catheter). Doctors will follow participants for two years to find out how well the treatment prevents the cancer from coming back or growing deeper. They will also track side effects, ask patients to complete quality-of-life surveys, and test urine samples to see how the immune system responds.
At a glance
What is this study about?
Bladder cancer often begins in the cells lining the inside of the bladder. When it stays within this surface lining, it is known as non-muscle invasive bladder cancer. However, some tumours are considered 'high-risk', meaning there is a greater chance they could come back or spread into the deeper muscle wall of the bladder. Doctors usually perform a minor operation through the urethra to remove these tumours, but extra treatment is often needed to keep the cancer from returning.
This clinical trial is testing a medicine called IMUNO BCG Moreau RJ. BCG is an immunotherapy made from a weakened bacterium. When placed into the bladder, it helps wake up your body's natural immune system so it can find and destroy any microscopic cancer cells left behind. While BCG is widely used, this study is testing a specific version to see how safe and effective it is.
The main aim of the trial is to see how many patients remain cancer-free over a two-year period following their surgery. Researchers also want to measure whether the cancer gets worse, understand how the treatment affects everyday quality of life, and check how the immune system responds through regular urine tests.
Key takeaways
- Tests a specific BCG strain (IMUNO BCG Moreau RJ) for high-risk bladder cancer.
- Aims to prevent cancer from returning or invading deeper muscle over two years.
- The medicine is given directly into the bladder using a catheter.
- Researchers will track side effects, immune response, and overall quality of life.
- Participation is entirely voluntary and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and older of any sex who have been diagnosed with high-risk non-muscle invasive bladder cancer. This means the cancer has been found in the bladder lining, but tests have confirmed it has not grown into the surrounding bladder muscle.
To be considered, you must have recently had surgery (known as transurethral resection) to remove all visible tumours from your bladder. Your doctor and the study team will review your recent medical tests and general health to confirm if joining the study is safe and appropriate for 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.
- I am at least 18 years old.
- I have been diagnosed with high-risk bladder cancer.
- My cancer has not grown into the deeper bladder muscle layer.
- I have recently had surgery to remove my bladder tumour.
- I am able to attend regular hospital appointments for tests and treatment over two years.
What does participation involve?
If you take part, you will receive the study medicine directly into your bladder through a thin, flexible tube called a catheter. The liquid is held in the bladder for a short time before you pass it out naturally. You will have an initial set of weekly treatments, followed by planned follow-up appointments over a total period of 24 months (two years). During your visits, doctors will perform routine bladder checks, test your urine (including checks on how your immune system is responding), ask you to fill out questionnaires about how you are feeling, and closely monitor you for any side effects.
Potential risks and benefits
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Common questions
How is the study medicine given?
It is put directly into your bladder using a small, soft tube called a catheter. The medicine stays in your bladder for a short time and is then emptied when you go to the toilet.
Is this the same as chemotherapy?
No. BCG is an immunotherapy, not chemotherapy. It works by encouraging your own immune system to target and destroy cancer cells.
How long will I be in the study?
The study monitors your health and bladder for 24 months (two years) after your tumour removal surgery.
What happens if I cannot tolerate the treatment?
Your doctor can pause the medicine, treat your symptoms, or stop the study treatment entirely if the side effects are too uncomfortable.
Will taking part cost me anything?
No. The trial treatment and any extra medical tests related to the study are provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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