Active not recruitingPHASE3INTERVENTIONAL

Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients

This study, called ALBAN, is for people in Europe with a type of bladder cancer that hasn't spread into the muscle wall (non-muscle invasive bladder cancer) and is considered high-risk. Participants have never had a specific treatment called BCG before. The study aims to see if combining the standard treatment, BCG, with a newer drug called atezolizumab is more effective than BCG alone in stopping the cancer from returning. Half of the participants receive BCG only, and the other half receive BCG plus atezolizumab. Researchers will track how long participants remain free from cancer events to determine which approach works best. This is a Phase 3 trial, meaning it's a large study to confirm the effectiveness and safety of the new treatment combination.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

UNICANCER

Enrolment target

517

Start

17 Jan 2019

Estimated completion

01 Oct 2028

Bladder Cancer

What is this study about?

This study, called ALBAN, is designed for people who have been diagnosed with a type of early bladder cancer. This means the cancer has not grown deep into the bladder muscle. For some patients, this type of bladder cancer is considered 'high-risk,' meaning there's a higher chance it could come back or spread if not treated effectively. This particular study is for people who haven't had a specific bladder cancer treatment called BCG before.

The main aim of ALBAN is to see if a new combination of treatments works better than the standard treatment. The standard treatment involves giving a medicine called BCG directly into the bladder. The study is comparing this standard BCG treatment with a new approach: giving BCG along with another drug called atezolizumab. Atezolizumab is a type of immunotherapy that helps your body's immune system fight cancer. By comparing these two approaches, researchers hope to find out if adding atezolizumab makes the treatment more effective at preventing the cancer from returning.

This is a 'Phase 3' study, which means it's a large trial involving many people. The goal is to get clear answers about whether the new combination treatment is better than the existing treatment for this specific group of bladder cancer patients. The study is being carried out in different hospitals across Europe.

Key takeaways

This study compares a new combination treatment for early bladder cancer.
It tests BCG treatment alone versus BCG plus atezolizumab.
It's for people with high-risk, early bladder cancer who haven't had BCG before.
The main aim is to see which treatment prevents the cancer from returning more effectively.
This is a Phase 3 study, meaning it's a large trial to confirm the benefits and safety.
Results could help improve future treatments for this type of cancer.

Who may be eligible?

To join this study, participants needed to be at least 18 years old and have a specific type of high-risk, early-stage bladder cancer that hasn't spread into the muscle. Importantly, they must not have had BCG treatment for this cancer before. The doctors also needed to confirm the cancer diagnosis from tissue collected during surgery.

Before taking part, participants would have had scans (like CT or MRI) to make sure the cancer hadn't spread to other parts of their body. They also needed to be generally well, meaning they could carry out most daily activities without too much difficulty. Their blood pressure needed to be within a healthy range, and routine blood tests (checking blood counts and organ function) had to show healthy results.

For some patients, a second operation to remove the tumor might have been needed before they could join, to make sure all visible cancer was removed and to confirm the diagnosis. If you meet these general criteria, your doctor could then check the more detailed requirements.

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 18 years old or older.
I have high-risk bladder cancer that has not spread into the bladder muscle.
I have never received BCG treatment for my bladder cancer.
I am generally well and active.
My recent scans show the cancer has not spread to other organs.
My blood tests are within healthy ranges for my organs and blood counts.

Answer every question to see your result.

What does participation involve?

If you were eligible and chose to take part in this study, you would have been randomly assigned to one of two treatment groups: either receiving BCG alone or receiving BCG plus atezolizumab. This means a computer decides which treatment you get, much like flipping a coin, to ensure fairness.

Both treatments involve a course of medication. You would have had regular appointments at the hospital for these treatments and to have various check-ups. These check-ups would involve physical examinations, blood tests, and possibly scans to monitor your health and how the treatment is working. Doctors would also carefully check for any side effects.

The study would involve regular follow-up over a period of time to track your progress and see how long you remain free from cancer returning. The total duration of active treatment and follow-up would be explained in detail by your medical team.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing new treatments that are not yet widely available, and your health will be very closely monitored. However, there are also potential risks, as new treatments can have side effects that aren't fully known, and there's no guarantee the treatment will work for everyone. You would have been given a full explanation of all known potential risks and side effects for both treatments before you decided to join. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (38)

Groupe Jolimont - Hôpital de Jolimont
Verified postcode
Haine-Saint-Paul, Belgium
AZ Delta - Campus Rumbeke
Verified postcode
Roeselare, Belgium
Centre Hospitalier Universitaire Angers
Verified postcode
Angers, France
Centre Hospitalier Universitaire Bordeaux
Verified postcode
Bordeaux, France
Hôpital G. Montpied
Verified postcode
Clermont-Ferrand, France
Clinique Claude Bernard
Verified postcode
Ermont, France
CHU Grenoble
Verified postcode
Grenoble, France
Hôpital privé Toulon - Sainte Marguerite
Verified postcode
Hyères, France
Hôpital du Kremlin-Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France
Hôpital Saint Vincent
Verified postcode
Lille, France
Hôpital privé de la Louvière
Verified postcode
Lille, France
Hôpital Saint Philibert
Verified postcode
Lomme, France

Common questions

What is Non-Muscle Invasive Bladder Cancer?

It's an early form of bladder cancer where the cancer cells have not grown into the deeper muscle layer of the bladder wall.

What is BCG bladder instillation?

BCG is a medicine, often used as an immunotherapy, that's put directly into your bladder through a small tube. It helps your immune system fight the cancer.

What is atezolizumab?

Atezolizumab is an immunotherapy drug, usually given into a vein, that helps your body's own immune system to recognise and attack cancer cells more effectively.

What does 'high-risk' mean in this context?

It means there's a higher chance of the cancer coming back or progressing if not treated effectively, often due to the type or grade of the cancer cells.

Why is this not available to everyone?

Because it's a new combination treatment being tested, it's only available to people who meet specific criteria within the clinical study to assess its safety and effectiveness properly.