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Study of Atezolizumab Treatment Before Surgery in Patients with Bladder Cancer or Upper Urinary Tract Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on urothelial cancer affecting the bladder and upper urinary tract. The research examines the effectiveness of atezolizumab, a medication given before surgery to patients who either cannot receive standard chemotherapy treatment with cisplatin or choose not to receive it. Urothelial cancer is a type of cancer that develops in the cells lining the urinary system.

The treatment involves receiving atezolizumab through intravenous infusion. The medication is given at a dose of 1,200 mg, and patients may receive up to 2,400 mg over a treatment period lasting up to 6 months. Atezolizumab belongs to a group of medications called immune checkpoint inhibitors, which work by helping the body's immune system fight cancer cells.

The main purpose of this research is to determine if atezolizumab can reduce the size of the cancer before surgery and to study how the medication affects the body's immune system. The study will also monitor how well patients tolerate the treatment and track their progress after surgery. During the study, patients will undergo regular medical examinations and imaging tests to assess their response to the treatment.

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 evaluation
Your eligibility for the study will be assessed through medical tests including blood work and imaging scans (CT or MRI) within 4 weeks before starting
A tissue sample from your previous surgery will be evaluated
Your overall health status and ability to perform daily activities will be assessed using the ECOG Performance Scale
Step 2
Treatment phase
You will receive atezolizumab through an intravenous infusion
The medication will be given as Tecentriq 1,200 mg in the form of a solution for infusion
This treatment is given before your planned surgery
Step 3
Monitoring
Your cancer response to treatment will be assessed through imaging scans
Regular blood tests will monitor your body's response to treatment
Any side effects will be tracked throughout the treatment period
Step 4
Surgery
After completing the treatment phase, you will undergo planned surgery
For bladder cancer, this will be a cystectomy (removal of the bladder)
For upper urinary tract cancer, you will receive appropriate surgical treatment according to your specific case
Step 5
Follow-up period
Your recovery and health status will be monitored after surgery
Regular check-ups will assess if the cancer has returned
The total study duration may continue until July 2026

Who can join the trial?

16 criteria

Must be 18 years or older
Must be able and willing to provide written informed consent
Must be able to follow study protocol requirements
Must have remaining cancer tissue after initial bladder surgery (TURBT) or urinary tract examination
Must be suitable for and planning to undergo surgery to remove the bladder or upper urinary tract
Cancer must not have spread beyond nearby lymph nodes and must not have distant spread (based on CT or MRI scan within 4 weeks before study entry)
Must have tissue samples preserved in formalin available for laboratory testing
Must either decline or be unsuitable for traditional chemotherapy with cisplatin before surgery
Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
For women who can become pregnant: must have a negative pregnancy test within 2 weeks before starting treatment
For women who can become pregnant: must use reliable birth control during the study and for 5 months after the last dose
Must have adequate blood test results showing:
- Sufficient white blood cells and platelets
- Hemoglobin level of at least 9.0 g/dL
- Acceptable liver function tests
- Acceptable kidney function
- Normal blood clotting tests (unless on blood thinners)

Who cannot join the trial?

12 criteria

History of autoimmune disease (a condition where the body's immune system attacks healthy cells)
Previous treatment with immunotherapy (treatments that help your immune system fight cancer)
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart conditions or cardiovascular disease
Active infections, including hepatitis B, hepatitis C, or HIV
Other types of cancer within the last 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Pregnant or breastfeeding women
Severe kidney or liver problems
Known allergy or sensitivity to study medications
Major surgery within 4 weeks before starting the study treatment
Participation in other clinical trials within 28 days before starting this study
Any condition that, in the opinion of the study doctor, would make it unsafe to participate

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Verified sites

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

Verified
Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Verified
Hospital Del Mar
Barcelona, Spain
Verified
Hospital Universitario 12 De Octubre
Madrid, Spain

Trial locations

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Investigated drugs

Atezolizumab is a type of immunotherapy medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and fight cancer cells. This medication is designed to target and treat urothelial cancer, which affects the bladder and upper urinary tract. The medication is given to patients before they undergo surgery to help shrink the tumor and improve treatment outcomes.

Atezolizumab

What is already known about the treatment

Atezolizumab - A monoclonal antibody medication administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors used in cancer immunotherapy. It works by targeting and blocking the PD-L1 protein, which helps cancer cells hide from the immune system, thus enabling the body's immune cells to better detect and fight cancer cells. This medication is primarily used in the treatment of various types of cancer, including urothelial carcinoma (cancer of the bladder and urinary tract), and is being studied in clinical trials as a neoadjuvant therapy (treatment given before surgery) to potentially reduce tumor size and improve surgical outcomes.

Investigated diseases

Urothelial cancer
A type of cancer that begins in the cells lining the urinary system, particularly affecting the bladder and upper urinary tract. The disease develops when urothelial cells start growing abnormally and form tumors in the urinary system walls. It can occur in different forms, including rare histological subtypes, and may spread through various layers of the urinary tract tissue. The cancer can develop in both the bladder (from T1 high-grade to T4a stages) and the upper urinary tract, showing different growth patterns and cell characteristics. When located in the bladder, it can grow through the bladder's inner lining and muscle layers.
Upper urinary tract urothelial carcinoma (UTUC)
A specific form of urothelial cancer that develops in the lining of the upper urinary tract, including the renal pelvis and ureter. This cancer begins in the urothelial cells of the upper urinary system and can appear as high-grade or high-risk tumors. It typically grows from the inner lining of these structures and can progress to deeper tissue layers. The disease can affect one or both sides of the upper urinary system.