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Study comparing enfortumab vedotin versus chemotherapy combination (docetaxel, paclitaxel, vinflunine) in patients with previously treated advanced or metastatic bladder cancer

Registered 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 locally advanced or metastatic urothelial cancer, which is a type of cancer that develops in the urinary system. The research compares two treatment approaches: a medication called enfortumab vedotin versus standard chemotherapy drugs including vinflunine, docetaxel, or paclitaxel. All medications are given through intravenous administration (into a vein).

The main purpose of this research is to determine if enfortumab vedotin helps patients live longer compared to traditional chemotherapy treatments. The study is designed for patients whose cancer has continued to grow or spread after receiving previous treatments, including both platinum-based chemotherapy and immunotherapy.

During the study, patients will be randomly assigned to receive either enfortumab vedotin or one of the standard chemotherapy medications. The treatment will continue as long as it is helping the patient and side effects remain manageable. Throughout the study, doctors will monitor patients' overall health, perform regular medical examinations, and evaluate how well 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 assessment

    Before treatment begins, you will undergo laboratory tests to check your: blood cell counts, liver function, kidney function, and other health parameters

    Your doctor will evaluate your overall physical condition using the ECOG performance status scale (a measure of your ability to perform daily activities)

    A tissue sample from your tumor will be sent to a central laboratory for analysis

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either enfortumab vedotin or standard chemotherapy (vinflunine, docetaxel, or paclitaxel)

    All medications will be given through an intravenous infusion (directly into your vein)

  3. Step 3

    Treatment period

    Your treatment will continue as long as it is providing benefit and you are not experiencing unacceptable side effects

    Regular assessments will track changes in your cancer using imaging scans

    Your doctor will monitor your health status and any side effects throughout the treatment

  4. Step 4

    Quality of life assessment

    Throughout the study, you will complete questionnaires about your quality of life and health status

    These assessments use standard forms called QLQ-C30 and EQ-5D-5L

  5. Step 5

    Follow-up period

    After completing treatment, you will have regular follow-up visits to monitor your health

    The study will continue until February 2025

Who can join the trial?

12 criteria

  • You must sign an informed consent form approved by the ethics committee before any study procedures
  • You must be legally an adult according to local regulations
  • You must have confirmed urothelial cancer (cancer of the urinary system lining)
  • Your cancer must have progressed during or after treatment with immunotherapy (treatment that helps your immune system fight cancer)
  • You must have previously received treatment with platinum chemotherapy (cisplatin or carboplatin)
  • Your cancer must be advanced or spread to other parts of the body
  • A tumor tissue sample must be available for laboratory testing
  • You must have good physical function (ECOG score of 0 or 1, meaning you can perform daily activities)
  • Your blood tests must show: - Adequate white blood cell count - Adequate platelet count - Adequate hemoglobin level - Acceptable liver function - Acceptable kidney function
  • For women who can become pregnant: - Must have a negative pregnancy test - Must use effective birth control during the study and for 6 months after - Must not breastfeed during the study and for 6 months after
  • For men with partners who can become pregnant: - Must use condoms during the study and for 6 months after - Partner must use effective birth control - Must not donate sperm during this time
  • You must not participate in other clinical trials while in this study

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions to any medications
  • Active brain or spinal cord metastases (cancer that has spread to brain/spine) that are not treated and stable
  • Significant heart problems including:
    • Heart failure
    • Heart attack within past 6 months
    • Irregular heartbeat requiring medication
    • Active infection requiring systemic treatment (medications that affect entire body)
    • Other active cancers requiring treatment (except non-melanoma skin cancer or localized prostate cancer)
    • Any major surgery within 4 weeks before starting the study
    • Pregnancy or breastfeeding
    • Serious medical conditions that could interfere with study participation
    • Current participation in other clinical trials
    • Unable to swallow oral medications
    • Known HIV infection, active hepatitis B, or active hepatitis C
    • History of organ transplant requiring immunosuppression (medications that lower immune system function)
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Investigated drugs

Enfortumab vedotin is a medication designed to treat advanced bladder cancer (urothelial cancer). It works by targeting cancer cells with a specific protein on their surface, delivering a drug that helps kill these cancer cells. This medication is given through an intravenous (IV) infusion. Standard Chemotherapy refers to traditional cancer-fighting drugs that work by killing rapidly dividing cells in the body. In this trial, it serves as a comparison treatment to enfortumab vedotin. Chemotherapy is typically administered through an IV infusion and is a well-established treatment for various types of cancer, including bladder cancer.

What is already known about the treatment

Enfortumab Vedotin - An antibody-drug conjugate administered through intravenous infusion, specifically designed for treating locally advanced or metastatic urothelial cancer in patients who have received prior treatment. This medication works by combining a monoclonal antibody targeting Nectin-4 (a protein found on cancer cells) with a potent anti-cancer agent called monomethyl auristatin E, allowing for targeted delivery of the chemotherapy directly to cancer cells. As a novel targeted therapy in oncology, it represents an important treatment option for patients who have progressed after standard chemotherapy, with clinical trials showing promising results in survival outcomes compared to conventional chemotherapy treatments.

Investigated diseases

Urothelial Cancer - A type of cancer that begins in the urothelial cells, which line the urinary system, including the bladder, urethra, ureters, and renal pelvis. The disease typically starts in the bladder's inner lining and can grow into deeper layers of the bladder wall. When described as locally advanced, it means the cancer has grown into nearby tissues or lymph nodes. In metastatic cases, the cancer has spread beyond its original location to other parts of the body. The disease often develops gradually, with the first signs being blood in urine or changes in urination patterns. Urothelial cancer can affect both men and women, though it is more common in older adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517571-20-00Protocol code7465-CL-0301Estimated enrolment324 patientsSponsorAstellas Pharma Global Development Inc.

sourced from the EU Clinical Trials Register and site verification

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