Not recruiting

Study of Atezolizumab treatment in patients with metastatic bladder cancer (urothelial cancer) after radical cystectomy

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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 patients with urothelial cancer who have undergone radical cystectomy (surgical removal of the bladder) and experienced a biochemical relapse. The research investigates the effectiveness of atezolizumab, a medication that works by helping the immune system fight cancer cells. The treatment will be administered through intravenous infusion.

The purpose of this study is to evaluate how well patients respond to atezolizumab when their cancer returns after surgery, as detected by specific blood tests. The medication will be given at a dose of up to 1200 mg through an infusion into a vein. The treatment period may last up to 3 months.

During the study, patients will receive regular medical check-ups and undergo various tests to monitor their condition. These will include blood tests and imaging scans to track how the cancer responds to the treatment. The study will use specialized blood tests called ctDNA (circulating tumor DNA) to detect cancer activity and determine how well the treatment is working.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive atezolizumab through an intravenous infusion (delivered directly into your vein)
This treatment begins after your radical cystectomy surgery (surgical removal of the bladder)
Your doctor will monitor your condition using CT scans and blood tests to check for cancer markers
Step 2
Monitoring period
Regular blood samples will be taken to analyze ctDNA (small pieces of cancer DNA in your blood)
CT scans will be performed to check for any visible signs of cancer
Your physical condition will be assessed using the ECOG scale (a measure of your daily living abilities)
Step 3
Response evaluation
Your response to treatment will be measured by two factors:
The absence of cancer DNA in your blood samples
No visible signs of cancer on your CT scans
Step 4
Treatment duration
The study continues until April 2027
Your participation duration will depend on your individual response to treatment
Regular health assessments will continue throughout your participation in the study

Who can join the trial?

9 criteria

Must be at least 18 years old when signing the consent form
Must be able to read and understand the study information materials both verbally and in writing
Must have a good performance status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal limitations)
Must have urothelial cancer in the bladder that has invaded the muscle layer (stages T2-4a)
Must be scheduled for radical cystectomy (complete surgical removal of the bladder)
Must have had imaging scans (PET/CT) of chest, abdomen, and pelvis showing no signs of cancer spread above the lower part of the aorta
Must be willing and able to follow all study procedures and requirements
For male participants: must agree to either avoid sexual intercourse or use condoms, and not donate sperm during the study period
Must sign an informed consent form indicating voluntary agreement to participate in the study

Who cannot join the trial?

13 criteria

Prior treatment with any immune checkpoint inhibitors (medications that help the immune system fight cancer)
Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune diseases (conditions where the immune system attacks healthy body tissues)
Ongoing treatment with steroids or other immunosuppressive medications
Uncontrolled infections or active hepatitis B or C
Significant heart conditions or uncontrolled high blood pressure
Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer)
Major surgery within 4 weeks before starting the study treatment
Participation in other clinical trials within 4 weeks before starting this study
Pregnant or breastfeeding women
Known allergies to study medications or their components
Serious medical conditions that could interfere with study participation
Unable to provide informed consent

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Odense University Hospital
Odense, Denmark

Trial locations

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Investigated drugs

Based on the provided trial data, I cannot definitively identify specific medications to list and describe, as the source text only mentions general categories of treatments: PD-1/PD-L1 targeted agents These are immunotherapy medications that help the immune system recognize and fight cancer cells. They work by blocking proteins called PD-1 or PD-L1 that can prevent the immune system from attacking cancer cells. Immunotherapy (IO) treatment This refers to treatments that boost the body's natural defenses to fight bladder cancer. It works by helping your immune system to better recognize and destroy cancer cells. Note: The trial appears to be studying treatments for metastatic bladder cancer, but specific medication names are not provided in the source data.

Atezolizumab

What is already known about the treatment

Based on the provided clinical trial data, which focuses on urothelial cancer treatment, no specific medication names are directly mentioned in the source data. The trial (TOMBOLA) appears to investigate PD-1/PD-L1 targeted agents, so I can provide descriptions for the common medications in this class: Pembrolizumab – An intravenously administered immunotherapy medication belonging to the class of PD-1 inhibitors, used in the treatment of advanced urothelial cancer and other malignancies. This monoclonal antibody works by blocking the PD-1 receptor on T-cells, enabling the immune system to better recognize and attack cancer cells. It is typically administered every three weeks in a clinical setting and has shown significant efficacy in treating metastatic bladder cancer. Atezolizumab – A PD-L1 inhibitor administered through intravenous infusion, specifically approved for treating advanced or metastatic urothelial carcinoma. This immunotherapy medication works by binding to PD-L1 on tumor cells, preventing them from evading immune system detection, and has demonstrated effectiveness in patients who have failed or are ineligible for platinum-based chemotherapy. Nivolumab – An intravenous immunotherapy medication in the PD-1 inhibitor class, used to treat various cancers including advanced urothelial carcinoma. It functions by blocking the interaction between PD-1 and its ligands, enhancing T-cell response against tumor cells, and is typically administered every two or four weeks as determined by the treating physician.

Investigated diseases

Urothelial cancer - A type of cancer that begins in the cells that line the urinary system, most commonly starting in the bladder. It develops when cells in the urothelial lining start growing abnormally and form tumors. The cancer typically starts in the bladder's inner lining and can spread to deeper tissue layers over time. This disease can affect any part of the urinary tract, including the renal pelvis, ureters, and urethra. The condition usually develops gradually, with cells becoming increasingly abnormal before turning into cancer.