Active not recruitingPHASE3INTERVENTIONAL

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy

This research is testing a new treatment called atezolizumab for a specific type of bladder cancer that has grown into the bladder muscle. After surgery to remove the bladder, some people may still have very small amounts of cancer cells floating in their blood, which can be detected by a special blood test. The study wants to see if atezolizumab can help prevent the cancer from returning in these patients. It compares atezolizumab to a dummy drug (placebo) in a group of people who are at a higher risk of their cancer coming back. The goal is to find out if this treatment is both effective and safe in preventing cancer recurrence.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

761

Start

03 May 2021

Estimated completion

01 Oct 2026

Muscle-invasive Bladder Cancer

What is this study about?

This study is about a type of bladder cancer that has grown into the muscle layer of the bladder wall. This is a more serious type of bladder cancer, often treated with surgery to remove the bladder (a procedure called a cystectomy). Even after successful surgery, there's a chance the cancer could return, especially if tiny cancer cells, invisible to regular scans, are still present in the body.

Doctors can now use a very sensitive blood test to look for tiny fragments of cancer DNA in the blood. If these fragments are found, it suggests that there might still be some cancer cells in the body, and the cancer is more likely to come back. This study is focusing on people who have had their bladder removed and whose blood tests show these tiny cancer DNA fragments.

The main aim of the study is to see if a drug called atezolizumab can help stop the cancer from coming back in these patients. Atezolizumab is a type of immunotherapy, which means it works by helping your body's own immune system fight cancer cells. The study will compare atezolizumab with a placebo (a dummy drug with no active ingredients) to see if it makes a difference. This kind of research is very important because it could lead to new ways to prevent bladder cancer from returning after surgery.

Key takeaways

This study is for bladder cancer that has spread into the muscle after surgery.
It tests if atezolizumab can stop cancer from returning if tiny cancer cells are still found in the blood.
You might receive the active drug or a dummy drug (placebo).
Participation involves regular hospital visits for treatment and checks.
The aim is to find out if this new treatment is safe and effective.

Who may be eligible?

To join this study, people must have been diagnosed with bladder cancer that has grown into the muscle layer. They must have had surgery to remove their bladder, and the surgery must have successfully removed all visible cancer. Importantly, a special blood test must show signs of tiny cancer cells still being present in their body.

Participants should also have fully recovered from their bladder removal surgery, with at least six weeks passed since the operation, and be enrolled in the study within 24 weeks of the surgery. Scans that check the body for cancer must show no signs of cancer having spread to other parts of the body.

There are also specific requirements about previous treatments. For example, some people who didn't get chemotherapy before surgery will be eligible if they can't have or don't want cisplatin-based chemotherapy after surgery. The study is open to both men and women, aged 18 and over.

Quick self-check

Have you had bladder cancer that grew into the muscle?
Did you have surgery to remove your bladder?
Are your recent scans clear, showing no spread of cancer?
Have you recovered well from your bladder surgery?
Are you able to provide blood samples for special tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll first have some tests, including blood tests and scans, to make sure you're suitable. If you meet the criteria, you'll then be randomly assigned to either receive the study drug, atezolizumab, or a placebo (which looks the same but contains no active medicine). Neither you nor your doctor will know which one you're receiving. Both medicines are given through an IV drip.

You'll have regular visits to the hospital for your treatment and check-ups. These visits will involve blood tests to monitor your health and the cancer, as well as scans to check if the cancer has returned. The exact number and frequency of visits, as well as the total length of your participation, will be explained by the study team, but typically these types of studies involve regular follow-up over several months or even a few years.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits. You would receive close medical attention and access to a new treatment, atezolizumab, which could potentially help prevent your bladder cancer from returning. However, it's also possible that you might receive the placebo, which won't directly treat your cancer. There are potential risks associated with any medication, including atezolizumab. You might experience side effects, which the study team will explain to you in detail. There will also be risks from the tests and procedures involved. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (148)

Cancer Care Centers of Brevard
Rockledge, United States
Optum Health Care
Las Vegas, United States
Cleveland Clinic
Cleveland, United States
AHN Cancer Institute ? Allegheny General Hospital
Pittsburgh, United States
Centro Medico Austral
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
AZ KLINA
Brasschaat, Belgium
UZ Gent
Ghent, Belgium
Oncocentro Serviços Medicos E Hospitalares Ltda
Fortaleza, Brazil
CETUS Hospital Dia Oncologia
Belo Horizonte, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Hospital Moinhos de Vento
Porto Alegre, Brazil

+136 more sites — see the official record for the full list.

Common questions

What is 'muscle-invasive bladder cancer'?

This is a type of bladder cancer where the cancer cells have grown into the muscle layer of the bladder wall, making it more serious than cancers just on the surface.

What is 'ctDNA positive'?

It means a special blood test found tiny bits of cancer DNA floating in your blood, suggesting there might still be some cancer cells in your body after surgery.

What is atezolizumab?

Atezolizumab is a drug that helps your body's immune system recognise and fight cancer cells. It's a type of immunotherapy.

Why is there a placebo?

A placebo helps researchers fairly compare the new drug to no active treatment, to see if the drug really makes a difference. It's important for understanding the drug's true effects.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're receiving atezolizumab or the placebo until the study ends.