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Study on the Effectiveness of Durvalumab and BCG in Treating High-Risk, Non-Muscle Invasive Bladder Cancer in Patients New to BCG Treatment

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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 the treatment of non-muscle invasive bladder cancer, a type of bladder cancer that has not spread into the muscle layer of the bladder. The study will evaluate the effectiveness and safety of a combination therapy using Durvalumab and Bacillus Calmette-Guérin (BCG), compared to the standard treatment of BCG alone. Durvalumab is a medication that helps the immune system fight cancer, while BCG is a vaccine that is used to treat bladder cancer by stimulating the immune system.

The purpose of the study is to assess how well the combination of Durvalumab and BCG works in preventing the return of cancer, known as disease-free survival. Participants in the study will receive either the combination therapy or BCG alone. The study will last for up to 12 months, during which participants will be monitored regularly to evaluate the treatment's effectiveness and any side effects. The study aims to provide more information on whether adding Durvalumab to the standard BCG treatment can improve outcomes for patients with this type of bladder cancer.

Throughout the study, participants will undergo regular check-ups and assessments to track their health and the progress of the treatment. The study will also look at other important outcomes, such as the time it takes for the cancer to become muscle-invasive or spread, and the overall survival rate of participants. The information gathered from this study will help determine if the combination of Durvalumab and BCG is a more effective treatment option for patients with non-muscle invasive bladder cancer.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of durvalumab and BCG therapy, while the other group will receive BCG therapy alone. This assignment is random, like flipping a coin, to ensure fairness and objectivity in the study.

  2. Step 2

    Treatment administration

    If assigned to the combination therapy group, you will receive durvalumab through an intravenous infusion. This means the medication will be given directly into your vein. The dosage and frequency will be determined by the study team based on the study protocol.

    In both groups, BCG will be administered directly into the bladder through a process called intravesical use. This involves inserting a catheter into the bladder to deliver the medication. The frequency and duration of this treatment will also be determined by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular check-ups will be scheduled to monitor your health and the effectiveness of the treatment. These check-ups may include physical exams, blood tests, and imaging studies.

    You will be asked to report any side effects or changes in your health to the study team. This information is crucial for assessing the safety and efficacy of the treatment.

  4. Step 4

    End of study participation

    The study is expected to continue until September 2025. Your participation will involve regular visits and follow-ups until the study concludes or until your doctor advises otherwise.

    At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

11 criteria

  • Patients must have non-muscle invasive bladder cancer.
  • Patients should not have received prior treatment with BCG (a type of bladder cancer treatment) or should have stopped BCG treatment more than 3 years before joining the study.
  • Patients must have a local confirmation of high-risk transitional cell carcinoma (a type of bladder cancer) that is confined to the inner layers of the bladder.
  • The tumor must be classified as high-risk, which means it meets one of the following conditions:
    • T1 tumor (a tumor that has grown into the connective tissue beneath the bladder lining but not into the muscle layer).
    • High grade/G3 tumor (a tumor with cells that look very different from normal cells and tend to grow and spread more aggressively).
    • CIS (carcinoma in situ, a flat tumor on the bladder lining).
    • Multiple, recurrent, and large tumors, with the largest tumor being at least 3 cm in diameter.
    • All visible tumors must be completely removed before joining the study, with the procedure done no more than 4 months before joining. Patients with remaining CIS after the procedure are still eligible.
    • Patients must not have had prior radiotherapy (radiation treatment) for bladder cancer.
    • Patients must not have been treated with immune-mediated therapies for cancer, such as anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed cell death ligand 2 antibodies. Patients who have received cancer vaccines are not eligible.
    • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that is not non-muscle invasive bladder cancer cannot participate.
  • Patients who have had an organ transplant cannot participate.
  • Patients with an active infection that requires treatment with antibiotics cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to any of the study drugs cannot participate.
  • Patients who have received another investigational drug within the last 30 days cannot participate.
  • Patients with a known history of HIV, hepatitis B, or hepatitis C cannot participate.
  • Patients with an autoimmune disease, which is when the body's immune system attacks its own healthy cells, cannot participate.
  • Patients who have had a major surgery within the last 4 weeks cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
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Investigated drugs

  • Durvalumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, Durvalumab is being tested to see if it can help improve the treatment of bladder cancer when used in combination with another therapy.

  • Bacillus Calmette-Guerin (BCG)

    is a type of therapy that uses a weakened form of bacteria to stimulate the immune system. It is commonly used to treat bladder cancer by triggering the body's natural defenses to fight the cancer cells. In this study, BCG is being used alone and in combination with Durvalumab to see which approach is more effective in treating bladder cancer.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating non-muscle invasive bladder cancer, particularly in combination with Bacillus Calmette-Guerin (BCG) therapy. The main therapeutic indication for durvalumab in this context is to improve disease-free survival in patients with high-risk bladder cancer. At the molecular level, durvalumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system, thereby allowing the body's immune system to better detect and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Non-muscle invasive bladder cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer of the bladder wall. It often begins with the formation of small tumors on the bladder lining, which can vary in number and size. As the disease progresses, these tumors may grow larger and potentially recur after removal. The cancer is typically detected at an early stage, which means it is confined to the inner layers of the bladder. Over time, if not managed, there is a risk that the cancer could invade deeper layers of the bladder or spread to other parts of the body. Monitoring and regular check-ups are crucial to manage the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505341-23-00Protocol codeD419JC00001(POTOMAC)Estimated enrolment1 026 patientsSponsorAstraZeneca AB

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