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Study on the Effectiveness and Safety of Durvalumab with Gemcitabine and Cisplatin for Patients with Muscle-Invasive Bladder Cancer

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 clinical trial is focused on studying a type of bladder cancer known as muscle-invasive bladder cancer. The study is investigating the effectiveness and safety of a treatment plan that includes a combination of medications. Initially, patients will receive a combination of Durvalumab, Gemcitabine, and Cisplatin as a pre-surgery treatment. After surgery, patients will continue with Durvalumab alone as a follow-up treatment. Durvalumab is a type of medication that helps the immune system fight cancer cells, while Gemcitabine and Cisplatin are chemotherapy drugs that work by stopping the growth of cancer cells.

The purpose of this study is to determine how well this treatment plan works and how safe it is for patients with muscle-invasive bladder cancer. The study will involve several stages, starting with the combination treatment before surgery, followed by surgery, and then continuing with Durvalumab alone. Patients will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period to assess the treatment's effectiveness and any side effects.

Participants in the study will be closely observed to see how their cancer responds to the treatment and to ensure their safety throughout the process. The study aims to provide valuable information that could improve treatment options for people with muscle-invasive bladder cancer in the future.

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

    The initial phase involves the administration of a combination of medications to treat muscle-invasive bladder cancer.

    The medications used are durvalumab, gemcitabine, and cisplatin. These are administered intravenously, meaning they are given through a vein.

    This phase is known as the neoadjuvant treatment phase, which means the treatment is given before the main treatment, such as surgery.

  2. Step 2

    Surgery

    Following the initial treatment phase, a surgical procedure called radical cystectomy is planned.

    This surgery involves the removal of the bladder and is a standard treatment for muscle-invasive bladder cancer.

  3. Step 3

    Post-surgery treatment phase

    After surgery, the treatment continues with the administration of durvalumab alone.

    This phase is referred to as the adjuvant treatment phase, which means the treatment is given after the main treatment to help prevent cancer from returning.

    Durvalumab is administered intravenously during this phase.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring and follow-up appointments are scheduled to assess the effectiveness and safety of the treatment.

    These appointments may include various tests and evaluations to track the progress of the treatment and the patient's health status.

Who can join the trial?

9 criteria

  • Patients must have a type of bladder cancer called muscle-invasive transitional cell carcinoma (TCC), confirmed by a doctor through tests.
  • The cancer should be at a stage where it can be surgically removed, specifically stages T2 to T4a, with no spread to distant parts of the body (N0/1M0).
  • Patients should be planning to have a surgery called radical cystectomy, which involves removing the bladder.
  • Patients must not have received any previous treatments like chemotherapy or immunotherapy for this type of bladder cancer.
  • Patients should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • A sample of the tumor must be available before joining the study.
  • Patients should have a life expectancy of at least 12 weeks when they start the study.
  • Both male and female patients are eligible to participate.
  • Patients must be within the age range of 18 to 64 years old.

Who cannot join the trial?

6 criteria

  • Patients who do not have a confirmed diagnosis of muscle-invasive transitional cell carcinoma (TCC) of the bladder. This means that the cancer must be confirmed by examining tissue samples under a microscope.
  • Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
  • Patients who are not able to follow the study procedures or comply with the study requirements. This means that participants must be able to understand and follow the instructions given by the study team.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe. This means that if a patient has other health issues that could affect the study results or their safety, they may not be able to participate.
  • Patients who are pregnant or breastfeeding. This is because the study may involve treatments that could affect the baby.
  • Patients who are participating in another clinical trial. This is to ensure that the results of the study are not influenced by other treatments or interventions.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the body's immune system fight cancer. It is given to patients both before and after surgery to see if it can improve outcomes in muscle-invasive bladder cancer.

  • Gemcitabine

    is a chemotherapy drug used in this trial to kill cancer cells. It is given in combination with other treatments to enhance its effectiveness against bladder cancer.

  • Cisplatin

    is another chemotherapy drug used alongside gemcitabine in this trial. It works by damaging the DNA of cancer cells, which helps to stop their growth and spread.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating muscle-invasive bladder cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, Durvalumab enables the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody and is being evaluated for its potential to improve outcomes in combination with chemotherapy drugs like Gemcitabine and Cisplatin.

  • Gemcitabine

    Gemcitabine is given through intravenous infusion and is a well-established chemotherapy medication used in the treatment of various cancers, including bladder cancer. It works by interfering with the DNA replication process, thereby preventing cancer cells from growing and dividing. Gemcitabine is classified as an antimetabolite and is often used in combination with other chemotherapy agents to enhance its effectiveness.

  • Cisplatin

    Cisplatin is administered intravenously and is a widely used chemotherapy drug for treating several types of cancer, including bladder cancer. It functions by forming cross-links in DNA, which ultimately leads to cell death. Cisplatin is classified as a platinum-based chemotherapy agent and is frequently used in combination with other drugs to improve therapeutic outcomes.

Investigated diseases

Muscle-Invasive Bladder Cancer – This disease is characterized by the growth of cancerous cells in the muscle layer of the bladder wall. It begins when transitional cells, which line the bladder, undergo abnormal changes and start to multiply uncontrollably. As the disease progresses, the cancer can invade deeper layers of the bladder and potentially spread to nearby tissues or organs. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases advancing more rapidly than others. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510015-19-00Estimated enrolment1 055 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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