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Study on Atezolizumab for Patients with High-Risk Muscle-Invasive Bladder Cancer with Positive ctDNA After 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 high-risk muscle-invasive bladder cancer, a type of cancer that affects the bladder and can spread to other parts of the body. The study is investigating the effects of a treatment called atezolizumab, which is a type of medication known as an anti-PD-L1 antibody. This medication is designed to help the immune system recognize and fight cancer cells more effectively. The trial will compare the effects of atezolizumab with a placebo in patients who have undergone surgery to remove the bladder cancer and are found to have circulating tumor DNA (ctDNA) in their blood, which indicates a higher risk of cancer returning.

The purpose of the study is to evaluate how well atezolizumab works in preventing the return of cancer in these patients. Participants in the study will receive either atezolizumab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period of time to assess their disease-free survival, which refers to the length of time patients remain free from cancer after treatment. The study will also look at other factors, such as overall survival and the presence of any side effects from the treatment.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the status of their cancer. These tests may include blood tests to check for ctDNA and other markers, as well as imaging tests to look for any signs of cancer returning. The study aims to provide valuable information on the effectiveness of atezolizumab as an additional therapy for patients with high-risk muscle-invasive bladder cancer, potentially offering a new option for preventing cancer recurrence in this group of patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of high-risk muscle-invasive bladder cancer and a positive test for circulating tumor DNA (ctDNA) following surgery.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either the medication atezolizumab or a placebo. Atezolizumab is an anti-PD-L1 antibody, which is a type of protein that helps the immune system fight cancer cells.

  3. Step 3

    Medication administration

    The medication or placebo is administered through an intravenous infusion. This means it is given directly into a vein through a drip. The dosage for atezolizumab is 840 mg.

  4. Step 4

    Treatment schedule

    The treatment is given on a regular schedule, which will be explained in detail by the healthcare team. The duration of the treatment phase is determined by the study protocol.

  5. Step 5

    Monitoring and assessments

    Regular monitoring is conducted to assess the effects of the treatment. This includes checking for any changes in health, measuring vital signs, and conducting laboratory tests.

    The presence of any side effects or adverse reactions is also monitored closely.

  6. Step 6

    Follow-up

    After the treatment phase, follow-up visits are scheduled to continue monitoring health and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of **muscle-invasive urothelial carcinoma** (a type of bladder cancer) with a dominant transitional cell pattern.
  • Must have undergone a surgical procedure to remove the bladder cancer.
  • Must have a tumor sample from surgery that can be used for specific tests, including checking for **PD-L1 expression** (a protein that may affect cancer growth) and other research purposes.
  • Must provide a blood sample after surgery to identify changes in the tumor's genetic material.
  • Must provide a blood sample for testing **circulating-tumor DNA (ctDNA)**, which is collected at least 6 weeks after surgery. This test looks for cancer-related DNA in the blood.
  • Must meet specific criteria related to previous treatments and health conditions, such as:
    • Having received or not received platinum-based chemotherapy before surgery. If not received, must be unable to take it due to health reasons, have refused it, or not be given it based on the doctor's decision.
    • Must have certain health conditions if unable to take cisplatin-based chemotherapy, such as:
      • **Impaired renal function**: Poor kidney function.
      • **Hearing loss**: Measured by a hearing test.
      • **Peripheral neuropathy**: Nerve damage causing tingling or sensory changes.
      • **ECOG Performance Status of 2**: A scale used to assess how a disease affects daily living abilities.
      • Both male and female participants are eligible.
      • Participants from vulnerable populations are included.

Who cannot join the trial?

5 criteria

  • Patients who have not had a surgery called a cystectomy, which is the removal of the bladder.
  • Patients who do not have circulating-tumor DNA (ctDNA) within 24 weeks after their cystectomy. This is a type of DNA that comes from cancer cells and is found in the blood.
  • Patients who are not considered high-risk for muscle-invasive bladder cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or are part of a vulnerable population that requires special protection.
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Investigated drugs

Atezolizumab is a medication used in this clinical trial. It is an antibody that works by blocking a protein called PD-L1. This protein can prevent the immune system from attacking cancer cells. By blocking PD-L1, atezolizumab helps the immune system to recognize and destroy cancer cells more effectively. In this trial, it is being tested as an additional treatment for patients with high-risk muscle-invasive bladder cancer who have undergone surgery to remove the bladder and are found to have circulating tumor DNA, which indicates the presence of cancer cells in the body.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials as an adjuvant therapy for patients with high-risk muscle-invasive bladder cancer who are positive for circulating tumor DNA following cystectomy. The main therapeutic indication for atezolizumab in this context is to improve disease-free survival in these patients. 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

High-risk muscle-invasive bladder cancer – This is a type of bladder cancer that has spread into the muscle layer of the bladder wall. It is considered high-risk due to its potential to grow and spread more aggressively compared to non-muscle-invasive bladder cancer. The disease often begins with symptoms such as blood in the urine, frequent urination, or pain during urination. As it progresses, it may invade surrounding tissues and organs, potentially leading to more severe symptoms. The progression of this cancer can vary, with some cases remaining localized while others may metastasize to distant parts of the body. Regular monitoring and medical evaluation are crucial to understanding its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502705-15-00Protocol codeBO42843Estimated enrolment247 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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