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Study on Durvalumab, Tremelimumab, and Enfortumab Vedotin for Patients with Muscle Invasive Bladder Cancer Ineligible or Refusing Cisplatin

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 the treatment of Muscle Invasive Bladder Cancer, a type of cancer that affects the bladder muscle. The study involves the use of several medications, including Durvalumab, Tremelimumab, and Enfortumab Vedotin. These medications are being tested in combination to see how effective and safe they are for patients who cannot use or choose not to use a common chemotherapy drug called cisplatin. The purpose of the study is to evaluate the safety and effectiveness of these drug combinations in patients undergoing surgery to remove the bladder.

Participants in the study will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will compare the results of using these medications with the results of surgery alone. The trial will last for a period of time, during which the safety and effects of the treatment will be closely monitored. This includes checking for any side effects and assessing how well the treatment works in preventing the cancer from returning or spreading.

The study aims to provide valuable information on the potential benefits of using Durvalumab, Tremelimumab, and Enfortumab Vedotin together for treating Muscle Invasive Bladder Cancer. It will also look at the overall survival rates of patients, the time it takes for the disease to return, and the quality of life of participants. The trial is expected to continue until 2028, with the hope of finding a more effective treatment option for patients with this type of cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A tumor sample is required before starting the study.

  2. Step 2

    Treatment phase 1: safety run-in

    The first phase involves assessing the safety and tolerability of the treatment combination. This includes durvalumab, tremelimumab, and enfortumab vedotin.

    These medications are administered through an intravenous infusion. The frequency and dosage are determined by the study protocol.

  3. Step 3

    Treatment phase 2: main study

    The main study phase compares the effectiveness of the treatment combination against surgery alone.

    The focus is on the complete response rate and event-free survival.

  4. Step 4

    Medication details

    Durvalumab and tremelimumab are administered intravenously. The specific schedule is outlined in the study protocol.

    Enfortumab vedotin is also given intravenously, with the dosage and frequency specified by the study.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess safety and effectiveness. This includes checking vital signs, laboratory tests, and performance status.

    Follow-up assessments are scheduled to evaluate overall survival, disease-free survival, and other health outcomes.

  6. Step 6

    End of study

    The study is estimated to conclude in September 2028.

    Final assessments will be conducted to gather data on long-term outcomes and any potential side effects.

Who can join the trial?

10 criteria

  • Participants must have **bladder cancer** that has been confirmed through a test called **histology** or **cytology**.
  • Participants can have a type of bladder cancer called **transitional cell carcinoma** (TCC) or a mix of transitional and non-transitional cell types.
  • Participants should have a specific stage of bladder cancer known as **muscle-invasive bladder cancer (MIBC)**, with certain tumor stages (T2-T4aN0/1M0) or another stage (T1N1M0).
  • Participants should not have received any previous **systemic chemotherapy** or **immunotherapy** for treating their bladder cancer.
  • Participants must be medically fit to undergo a surgery called **cystectomy** and able to receive treatment before surgery, known as **neoadjuvant therapy**.
  • Participants should have an **ECOG performance status** of 0, 1, or 2, which is a scale used to assess how well a person can perform daily activities.
  • A sample of the tumor must be available before joining the study.
  • Participants must be unable to receive a chemotherapy drug called **cisplatin** due to certain health reasons or choose not to receive it.
  • Participants must have a life expectancy of at least 12 weeks when they start the study.
  • Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

  • Participants who have a different type of cancer other than bladder cancer cannot join the study.
  • Participants who are eligible for a treatment called cisplatin cannot join. Cisplatin is a type of chemotherapy used to treat cancer.
  • Participants who are not within the specified age range for the study cannot join. The study has specific age requirements.
  • Participants who are not able to give informed consent or understand the study details cannot join. This means they must be able to understand what the study involves and agree to participate.
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Investigated drugs

  • Durvalumab

    is a medication used to help the immune system detect and fight cancer cells. It works by blocking a specific protein that can prevent the immune system from attacking cancer cells, allowing the body to better target and destroy them.

  • Tremelimumab

    is another medication that helps the immune system fight cancer. It works by targeting a protein that can suppress the immune response, thereby enhancing the body's ability to attack cancer cells.

  • Enfortumab Vedotin

    is a type of targeted cancer therapy. It combines an antibody with a chemotherapy drug to specifically target and kill cancer cells while minimizing damage to normal cells. This medication is designed to deliver the chemotherapy directly to the cancer cells, increasing its effectiveness.

What is already known about the treatment

  • Durvalumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating bladder cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps the immune system detect and attack cancer cells. Durvalumab is classified as a monoclonal antibody and is being evaluated for use in patients who are ineligible for or refuse cisplatin treatment.

  • Tremelimumab

    Administered intravenously, this medication is under investigation in clinical trials for bladder cancer treatment. It functions by targeting and inhibiting CTLA-4, a protein that downregulates the immune response, thereby enhancing the body's ability to fight cancer. Tremelimumab is a monoclonal antibody and is being tested in combination with other drugs for patients who cannot or choose not to undergo cisplatin therapy.

  • Enfortumab Vedotin

    This drug is given intravenously and is being explored in clinical trials for its potential in treating bladder cancer. It is an antibody-drug conjugate that targets Nectin-4, a protein found on cancer cells, delivering a toxic agent directly to the tumor to kill cancer cells. Enfortumab Vedotin is part of a new class of targeted cancer therapies and is being studied for patients who are not candidates for cisplatin treatment.

Investigated diseases

Bladder Cancer – Bladder cancer is a disease where abnormal cells grow uncontrollably in the bladder, which is the organ that stores urine. It often begins in the cells lining the inside of the bladder and can spread to nearby tissues or other parts of the body. The progression of bladder cancer can vary, with some cases remaining confined to the bladder lining, while others may invade deeper layers or spread to other organs. Symptoms may include blood in the urine, frequent urination, and pain during urination. The disease is more common in older adults and is often linked to smoking and exposure to certain chemicals. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507342-84-00Protocol codeD910PC00001 - VolgaEstimated enrolment677 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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