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Study of Atezolizumab with BCG Treatment for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Who Have Not Previously Received BCG

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 high-risk non-muscle invasive bladder cancer who have undergone transurethral resection of the bladder. The research evaluates a treatment combining two medications: atezolizumab (given through intravenous infusion) and BCG (Bacillus Calmette-Guerin), which is administered directly into the bladder. The purpose is to determine if using both treatments together works better than using BCG alone.

The treatment plan involves receiving Tecentriq (atezolizumab) as an intravenous solution, with each dose containing 1,200 milligrams of medication. Patients will receive treatment for up to 12 months. During this time, some patients will receive both atezolizumab and BCG bladder treatments, while others will receive only BCG treatments.

Throughout the study, patients will have regular check-ups to monitor their health. These visits include medical examinations and quality of life assessments. The doctors will track how long patients remain free from cancer events and watch for any signs that the disease has returned or gotten worse. Blood and urine samples will be collected to study how the treatment is working.

The research process

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

  1. Step 1

    Initial evaluation

    Your participation begins after completing the surgical procedure and receiving confirmation of high-risk non-muscle invasive bladder cancer

    Medical imaging (CT scan or MRI) must be performed within 90 days before starting treatment to confirm the absence of cancer spread

    Basic health tests including blood pressure and laboratory tests will be conducted within 7 days before starting treatment

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: BCG treatment alone (bladder instillation)

    Group 2: BCG treatment plus atezolizumab (bladder instillation plus intravenous medication)

  3. Step 3

    Treatment period - Year 1

    Treatment will continue for one year

    You will receive BCG instillations directly into your bladder

    If assigned to group 2, you will also receive Tecentriq (atezolizumab) 1,200 mg through intravenous infusion

  4. Step 4

    Monitoring and evaluation

    Regular check-ups will occur every 12 weeks during the first two years

    Health assessments will include cystoscopy (bladder examination) and urine tests

    Quality of life questionnaires will be completed every 12 weeks

    Side effects will be monitored and recorded throughout the study

  5. Step 5

    Long-term follow-up

    After the first two years, check-ups will occur every 24 weeks for years 3-5

    Continued monitoring of your health status and cancer-related events

    The total study duration is expected to continue until October 2028

Who can join the trial?

13 criteria

  • Must be at least 18 years old (adult men and women)
  • Must have signed an informed consent form after the last bladder surgery
  • Must have high-risk non-muscle invasive bladder cancer confirmed by tissue examination
  • Must have had at least two surgical removals of the primary tumor
  • Must have no spread of cancer to pelvis, abdomen, or chest, confirmed by CT or MRI scan within the last 90 days
  • Must have an ECOG performance status of 2 or less (ability to perform daily activities)
  • Must have a life expectancy of at least 12 weeks
  • Must have controlled blood pressure (systolic below 160 mmHg and diastolic below 95 mmHg)
  • Must have adequate blood test results and organ function within 7 days before treatment
  • Must be registered in the social security system
  • Women who can become pregnant must agree to either avoid sexual intercourse or use highly effective contraception during treatment and for 5 months after the last dose of medication
  • Must be willing and able to follow the study protocol, including all treatments, scheduled visits, and examinations
  • Must have tumor tissue available for laboratory testing

Who cannot join the trial?

14 criteria

  • History of autoimmune diseases (conditions where the body's immune system attacks healthy cells)
  • Previous treatment with BCG therapy that was not successful
  • Active or untreated tuberculosis
  • Known allergies to any of the study medications
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Significant heart, liver, or kidney problems
  • Current participation in other clinical trials
  • Pregnant or breastfeeding women
  • Major surgery within 4 weeks before starting the study
  • Active or chronic infections requiring treatment
  • Previous treatment with immunotherapy medications
  • Mental conditions that could interfere with study compliance
  • History of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Conditions requiring long-term use of steroids or other immunosuppressive medications
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Investigated drugs

  • Atezolizumab

    is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from your immune system, allowing your body's natural defenses to better recognize and attack the cancer.

  • BCG (Bacillus Calmette-Guerin)

    is a treatment that's placed directly into the bladder through a catheter. It's made from weakened bacteria that stimulate your immune system to fight cancer cells in the bladder. This is a standard treatment for high-risk bladder cancer that hasn't invaded the muscle wall.

What is already known about the treatment

  • Atezolizumab

    A monoclonal antibody medication administered through intravenous infusion that works by targeting the PD-L1 protein to help the immune system fight cancer cells. This immunotherapy drug is currently approved and actively used in clinical practice for various types of cancer, including bladder cancer treatment. The medication functions by blocking the interaction between PD-L1 and PD-1, which normally helps cancer cells evade immune system detection, thus enabling the body's T-cells to better recognize and attack cancer cells.

  • BCG (Bacillus Calmette-Guerin)

    A bacterium-based immunotherapy medication administered directly into the bladder through catheter instillation, specifically used for treating non-muscle invasive bladder cancer. This well-established treatment has been a standard therapy for high-risk bladder cancer for several decades and works by stimulating the body's immune system to fight cancer cells within the bladder. The medication triggers an immune response that helps prevent cancer recurrence and progression, making it particularly effective after surgical removal of bladder tumors.

Investigated diseases

Non-muscle invasive bladder cancer - A type of bladder cancer that affects the inner lining of the bladder without invading the muscle layer. The cancer starts in the cells that line the bladder and can form small growths called papillary tumors or flat areas known as carcinoma in situ (CIS). The disease can occur in different stages, from very early superficial tumors to those that have grown deeper into the bladder lining. When classified as high-risk, it means the cancer has certain characteristics that make it more likely to return after initial treatment. The condition is typically discovered after patients experience symptoms such as blood in urine or changes in urination patterns.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517621-54-00Protocol codeUC-0160/1717Estimated enrolment517 patientsSponsorUnicancer

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