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

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 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.

  1. 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

  2. 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)

  3. 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

  4. 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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Investigated drugs

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.

What is already known about the treatment

  • Nivolumab

    Nivolumab is a medicine given as an infusion into a vein and is used to treat various types of cancer, including bladder cancer that has spread to other parts of the body. This medicine belongs to a group of drugs called immune checkpoint inhibitors, and it works by helping the body's own immune system recognize and attack cancer cells by blocking the PD-1 protein on the surface of immune cells. It is currently approved and widely used in medicine for the treatment of advanced urothelial carcinoma, especially in patients who have not responded to platinum-based chemotherapy.

  • Pembrolizumab

    Pembrolizumab is a medicine given intravenously and used to treat various types of cancer, including cancer of the urinary system that has spread beyond the bladder. This medicine belongs to a group of immunotherapy drugs that work by blocking the PD-1 protein on immune cells, allowing the immune system to better recognize and destroy cancer cells. Pembrolizumab is an approved medicine that is actively used in clinical practice to treat advanced urothelial carcinoma, especially when standard chemotherapy has not been effective.

  • Atezolizumab

    Atezolizumab is a medicine given as an infusion into a vein and is used to treat cancer of the bladder and urinary system that has spread to other organs. This medicine belongs to a group of immunotherapy drugs that work by blocking the PD-L1 protein on cancer cells and immune cells, which helps the body activate its own immune system against the cancer. Atezolizumab is approved and used to treat advanced or metastatic urothelial carcinoma in patients who are not suitable for chemotherapy or in whom chemotherapy has not been successful.

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.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510865-41-00Estimated enrolment282 patientsSponsorRegion Midtjylland

sourced from the EU Clinical Trials Register and site verification

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