Recruiting

Study of Atezolizumab After Chemo-radiotherapy for Patients with Muscle-invasive Bladder Cancer Not Eligible for Radical Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of bladder cancer known as muscle-invasive bladder cancer. This is a condition where cancer cells have spread into the muscle layer of the bladder. The study is investigating the use of a treatment called atezolizumab, which is also known by its code name RO5541267. Atezolizumab is a medication that helps the immune system fight cancer by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells.

The purpose of this study is to evaluate how effective atezolizumab is when used as a maintenance therapy after patients have received a combination of chemotherapy and radiotherapy. This is specifically for patients who are not able to undergo a surgery called radical cystectomy, which involves removing the bladder. The study aims to see if atezolizumab can help patients remain free of cancer for a longer period, specifically looking at disease-free survival over two years.

Participants in the study will first receive standard chemotherapy and radiotherapy. After completing this initial treatment, they will begin receiving atezolizumab. The study will monitor the participants over time to assess their health and any changes in their cancer status. The goal is to determine if atezolizumab can help maintain the benefits of the initial treatment and improve outcomes for patients with muscle-invasive bladder cancer. Some participants may receive a placebo instead of atezolizumab to compare the effects of the treatment. The study will also look at other factors such as overall survival, local control of the cancer, and the quality of life of the participants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The trial begins after completing standard chemo-radiotherapy. This treatment should be at least 60 Gy or equivalent, focused on the bladder.
The first administration of the medication atezolizumab must occur within 30 days, with a possible variation of 5 days, after the last session of radiotherapy.
Step 2
Medication administration
Atezolizumab is administered as a solution for infusion. This involves receiving the medication through a vein, typically in a hospital or clinic setting.
The dosage is 1,200 mg, and the frequency and duration of administration will be determined by the healthcare provider based on the study protocol.
Step 3
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health status and response to the treatment. These visits include physical examinations, laboratory tests, and imaging studies as needed.
Cystoscopy, a procedure to examine the inside of the bladder, will be performed at 2 and 5 years to evaluate local control of the cancer.
Step 4
Assessment of outcomes
The primary outcome is disease-free survival, assessed at 2 years. This measures the time from the start of the trial until the cancer progresses or any cause of death occurs.
Secondary outcomes include overall survival, local control rate, and quality of life, assessed at various intervals up to 5 years.
Step 5
End of trial
The trial is expected to conclude by May 31, 2028. Final assessments will be conducted to evaluate the long-term effects and outcomes of the treatment.

Who can join the trial?

20 criteria

Must have **muscle-invasive bladder cancer** confirmed by a test called histology.
Must have certain blood and body function levels:
- White blood cell count of at least 3000 per mm³.
- Platelet count of at least 100,000 cells per mm³.
- Hemoglobin level of at least 9 g/dL or corrected after a blood transfusion.
- Good kidney function with a clearance rate over 50 mL/min.
- Good liver function with specific enzyme levels not too high.
- Good heart function with normal levels of certain heart markers.
- Must be 18 years or older.
- Must have a **performance status** of 2 or less, which means being able to do some daily activities.
- Must have a life expectancy of at least 12 months.
- Must have completed a procedure called **transurethral resection of bladder tumor (TURBT)**.
- Must have received standard chemo-radiotherapy of at least 60 Gy on the bladder.
- Must not have major pelvic involvement, meaning pelvic nodes should be 15 mm or smaller on a CT scan.
- Must not have cancer spread to distant parts of the body (no distant metastasis).
- Must be unable to have a surgery called **radical cystectomy** due to age, other health issues, or personal choice.
- Must agree to use a reliable method of birth control during the study and for 120 days after the last treatment if of childbearing potential. Women must have a negative pregnancy test before starting the study.
- Must have given written consent to participate in the study.
- Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures as part of the study.
- Must have the first dose of a medication called **atezolizumab** within 30 days after the last session of radiotherapy.
- Must be part of a social security scheme.

Who cannot join the trial?

10 criteria

Patients who have had a different type of cancer in the past, unless it was a very early stage and has been completely treated.
Patients with an active infection that requires treatment with antibiotics.
Patients with a history of severe allergic reactions to similar medications.
Patients with an autoimmune disease, which is when the body's defense system attacks its own cells.
Patients who are pregnant or breastfeeding.
Patients who have received another investigational drug within the last 4 weeks.
Patients with a serious heart condition, such as heart failure or a recent heart attack.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of drug or alcohol abuse.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Centr Georges Francois Leclerc
Verified
Dijon, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Atezolizumab is a medication used in this clinical trial as a maintenance therapy. It is an anti-PD-L1 treatment, which means it helps the immune system to recognize and attack cancer cells. In this study, atezolizumab is given to patients with muscle-invasive bladder cancer who have already received chemo-radiotherapy. The goal is to see if it can help keep the cancer from coming back for at least two years.

Atezolizumab

What is already known about the treatment

Atezolizumab – Atezolizumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating muscle-invasive bladder cancer, particularly in patients who are not eligible for radical cystectomy. The main therapeutic indication for atezolizumab in this context is to serve as a maintenance therapy following chemo-radiotherapy, aiming to improve disease-free survival. At the molecular level, atezolizumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Muscle-invasive bladder cancer – This is a type of bladder cancer where the cancer cells have spread into the muscle layer of the bladder wall. It typically begins in the cells lining the bladder and progresses to invade the muscular part of the bladder. As the disease advances, it may spread to nearby tissues and organs, and potentially to distant parts of the body. The progression of this cancer can lead to symptoms such as blood in the urine, frequent urination, and pain during urination. The disease is more aggressive than non-muscle-invasive bladder cancer and requires more intensive management.