Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

To be able to join this study, you generally need to be at least 18 years old. People who are considered for the study have what doctors call 'high-risk' non-muscle-invasive bladder cancer. This means your cancer has certain features that make it more likely to come back or get worse, such as being a specific type (T1, high-grade/G3, or CIS) or having several large tumours. You must have had these tumours completely removed recently, usually within the last four months.

It's important that you haven't received BCG treatment for your bladder cancer recently, or that it was a long time ago (more than three years). Also, if you've had certain other types of cancer treatment that affect the immune system, particularly other drugs similar to Durvalumab, you wouldn't be able to join. You also cannot have had radiation therapy for bladder cancer in the past and cannot have cancer that has spread into the muscle of the bladder or to other parts of the body.

The study cannot include you if your bladder cancer has spread deep into the muscle (called muscle-invasive) or to other areas, or if you have another type of non-muscle-invasive cancer in other urinary organs, like the ureters or kidneys. You also can't be taking certain other cancer medications at the same time as this study treatment. The research team will carefully check all your medical information to make sure participating in the study is right and safe for you.

If you decide to take part in this study, you will be assigned to one of two treatment groups by chance, like flipping a coin. You might receive the new combination of Durvalumab plus BCG, or you might receive the standard BCG treatment alone. Neither you nor your doctor will get to choose which treatment you receive. Durvalumab is given as an infusion (into a vein) while BCG is put directly into your bladder using a thin tube.

Throughout the study, you'll have regular hospital visits for treatment, check-ups, and tests to monitor your health and how the treatment is working. These tests might include blood tests, urine tests, and bladder examinations (like cystoscopies) to look inside your bladder. The number and frequency of visits will be explained to you, but typically, clinical trials involve more frequent visits than routine care, especially at the beginning. The total duration of your participation, including follow-up after your main treatment, will also be explained in detail by the study team.