ALBAN : An open label, randomized, phase III trial, evaluating efficacy of Atezolizumab in addition to one year BCG (Bacillus CaLmette-Guerin) bladder instillation in BCG-naive patients with high-risk non-muscle invasive Bladder cANcer
This study, called ALBAN, is a major research trial comparing a new drug called Tecentriq (atezolizumab) alongside the usual BCG treatment for a type of bladder cancer. This is for people who have high-risk, early bladder cancer that has been removed but hasn't grown into the muscle of the bladder. The main goal is to find out if adding Tecentriq helps prevent the cancer from returning or getting worse over time. Researchers will also look at how safe the treatment is, how it affects quality of life, and other ways it might help patients.
At a glance
What is this study about?
Imagine you or someone you know has been diagnosed with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This means the cancer is in the lining of the bladder but hasn't grown deep into the muscle. Doctors usually remove these tumours with surgery, and then often give a treatment called BCG (Bacillus Calmette-Guérin) directly into the bladder to try and stop the cancer from coming back or getting worse. This particular study is for people whose NMIBC is considered 'high-risk', meaning there's a higher chance it could return or spread.
This study is looking at whether adding a new drug, called Tecentriq (atezolizumab), to the standard BCG treatment can make a difference. Tecentriq is an immunotherapy drug, which means it works by helping your body's own immune system fight the cancer. The researchers want to see if this combination treatment is more effective than BCG alone in preventing the cancer from coming back or progressing.
The main thing the study wants to measure is how long people stay free from the cancer returning or getting worse. They will also look at other important things like how long people live, how the treatment affects their quality of life, and whether the cancer progresses to a more serious stage. This is a "Phase III" study, which means it's a large trial designed to confirm if a new treatment is effective and safe compared to current standard care.
Key takeaways
- This study compares a new drug (Tecentriq) plus standard BCG with BCG alone for high-risk early bladder cancer.
- It aims to see if the new combination can better prevent cancer from returning or worsening.
- Participation involves regular hospital visits, treatments, and detailed monitoring.
- The study assesses cancer recurrence, progression, survival, and quality of life.
- It's a major Stage 3 trial to confirm the treatment's effectiveness and safety.
- You can withdraw from the study at any time, for any reason.
Who may be eligible?
To join this study, you would need to be at least 18 years old. Both men and women can take part. You must have been diagnosed with high-risk, non-muscle invasive bladder cancer, which means the cancer is in the surface layers of the bladder and hasn't spread into the deep muscle.
Before joining, doctors would need to confirm your cancer diagnosis and that it meets the specific criteria for this study. You would also need to be fit enough to undergo the treatments and assessments involved in the trial. There will be other specific medical checks and requirements that the study team will discuss 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.
- Are you 18 years old or older?
- Have you been diagnosed with high-risk non-muscle invasive bladder cancer?
- Has your cancer been removed and confirmed by a doctor?
- Have you not received BCG treatment for this cancer before?
- Are you generally well enough to participate in a clinical trial?
What does participation involve?
If you decide to join this study, you would be randomly assigned to receive either the standard BCG treatment plus Tecentriq, or just the standard BCG treatment. Being 'randomly assigned' is like flipping a coin – it helps ensure the study results are fair.
Tecentriq is given through a drip into your vein. The BCG treatment is given directly into your bladder using a thin tube. You would have regular hospital visits for these treatments and for check-ups. These check-ups will include bladder scopes (a camera look into the bladder), urine tests, blood tests, and scans to monitor your health and the cancer. You would also fill out questionnaires about your quality of life.
The study would involve regular follow-up for several years, even after your treatment courses are finished, to see how you're doing in the long term. The exact schedule of visits and duration of treatment will be explained in detail by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
Common questions
What is 'high-risk non-muscle invasive bladder cancer'?
It's an early form of bladder cancer that's in the lining of the bladder, hasn't grown into the muscle, but has a higher chance of coming back or getting worse.
What is BCG treatment?
BCG (Bacillus Calmette-Guérin) is a standard treatment for early bladder cancer, given directly into the bladder to stimulate the immune system to fight cancer cells.
What is Tecentriq (atezolizumab)?
Tecentriq is a type of immunotherapy drug that helps your body's immune system recognise and fight cancer cells more effectively.
What does 'randomised' mean in a study?
It means you are assigned to a treatment group by chance, like flipping a coin, to ensure the study results are fair and unbiased.
Will I have to pay to be in this study?
No, treatments and assessments directly related to the clinical trial 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.
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