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A study comparing erdafitinib delivery system to chemotherapy for patients with high-risk non-muscle-invasive bladder cancer who received BCG treatment

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 study involves people with high-risk non-muscle-invasive bladder cancer who have specific changes in their genes called FGFR alterations. Non-muscle-invasive bladder cancer means the cancer is in the inner lining of the bladder but has not grown into the deeper muscle layer of the bladder wall. High-risk means the cancer is more likely to come back or get worse. These individuals have already received treatment with Bacillus Calmette-Guérin, which is a type of vaccine used to treat bladder cancer by placing it directly into the bladder, but the cancer has either come back or the treatment could not be completed due to side effects. The study will compare a new treatment method using erdafitinib delivered through a device placed inside the bladder called an intravesical delivery system, known as TAR-210, with standard chemotherapy treatments that are also placed directly into the bladder.

The chemotherapy options that doctors may choose from include gemcitabine or mitomycin, which are medications that work to kill cancer cells. The erdafitinib treatment is given using a special catheter device that places the medication directly into the bladder where it can stay and work over time. The purpose of this study is to find out if the erdafitinib delivery system works better than the standard chemotherapy treatments in preventing the cancer from coming back or getting worse.

People in the study will be randomly assigned to receive either the erdafitinib intravesical delivery system or one of the chemotherapy treatments chosen by their doctor. The study will follow participants over time to see how well each treatment works and to check for any side effects. Before joining the study, all visible tumors must be completely removed, and participants must have testing to confirm they have the specific FGFR changes that the erdafitinib treatment targets. The study is designed for people who cannot have or do not want surgery to remove their bladder.

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

    Random assignment to treatment group

    After joining the study, you will be randomly assigned to one of two treatment groups.

    Group A will receive TAR-210 erdafitinib, which is a device that delivers medication directly into the bladder.

    Group B will receive intravesical chemotherapy chosen by your doctor, which means chemotherapy medication placed directly into the bladder. This may be either gemcitabine or mitomycin.

  2. Step 2

    Treatment administration

    All treatments in this study are given intravesically, which means the medication is placed directly into your bladder through a catheter (a thin tube inserted through the urethra).

    If you are assigned to Group A, you will receive the TAR-210 erdafitinib intravesical delivery system. This is a device that stays in your bladder and slowly releases the medication erdafitinib over time.

    If you are assigned to Group B, you will receive chemotherapy treatments with either gemcitabine or mitomycin placed directly into your bladder. Your doctor will decide which chemotherapy medication you will receive.

    The specific dosage, frequency, and duration of treatment will be determined according to the study protocol and your assigned group.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, you will have regular visits to monitor your condition and assess how the treatment is working.

    These visits will include examinations of your bladder and tests to check for any signs that the cancer has returned or progressed.

    Your doctor will also monitor you for any side effects or complications from the treatment.

  4. Step 4

    Disease-free survival assessment

    The main goal of this study is to measure disease-free survival, which means the length of time you remain free of cancer after treatment.

    Your medical team will regularly assess whether your bladder cancer has returned or spread.

    This assessment will continue throughout your participation in the study.

  5. Step 5

    Ongoing follow-up

    You will continue to be followed throughout the duration of the study.

    The study is expected to continue until March 2032, though your individual participation time may vary.

    Regular check-ups will be scheduled to monitor your health and the effectiveness of the treatment you received.

Who can join the trial?

6 criteria

  • You must have a confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (cancer that has not grown into the muscle layer of the bladder wall) with a specific type called papillary (finger-like growths). This includes high-grade Ta (cancer only in the inner lining) or T1 (cancer that has grown into the layer beneath the lining). You cannot have a type called CIS (flat cancer cells). Tumors with mixed cell types are allowed if the main type is urothelial (the most common bladder cancer type), but certain rare types like neuroendocrine and small cell are not allowed.
  • You must have a specific change in a gene called FGFR (fibroblast growth factor receptor). This change can be a mutation (an error in the gene) or a fusion (when parts of genes join together). This can be found by testing your urine or the tumor tissue removed during surgery.
  • All visible tumor must have been completely removed by surgery before joining the study. A test of your urine called cytology (looking at cells under a microscope) must not show cancer cells before you join the study. If your cancer had grown into a deeper layer called the lamina propria (T1), the doctor must have been able to see the muscle layer during surgery to make sure the cancer has not reached the muscle.
  • You must have received treatment with BCG (a type of immunotherapy for bladder cancer) in one of these ways: You received at least 5 out of 6 initial doses of BCG and either 2 out of 3 maintenance doses or 2 out of 6 doses of a second round of BCG, and your cancer came back or did not respond; OR you received a full initial course of BCG with or without maintenance, and your cancer came back within 12 months; OR you were unable to complete at least 5 doses of BCG because it caused side effects that required stopping treatment.
  • You must have an ECOG performance status (a measure of how well you can perform daily activities) of 0, 1, or 2. This means you are fully active, have some restrictions, or are able to care for yourself but cannot work.
  • You must either not be suitable for surgery to remove your bladder (called radical cystectomy) or you do not want to have this surgery.

Who cannot join the trial?

3 criteria

  • The study information provided does not list specific exclusion criteria, which are the reasons why a patient cannot participate in the clinical trial.
  • Generally, clinical trials may exclude patients based on factors such as other health conditions, previous treatments, or test results that do not meet the study requirements.
  • If you are interested in this study, a doctor involved in the research would need to review the complete study requirements to determine if you are eligible to participate.
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Investigated drugs

  • TAR-210 Erdafitinib

    is an investigational treatment system that delivers medicine directly into the bladder. It is designed to treat bladder cancer by targeting specific genetic changes in cancer cells called FGFR alterations. The system stays in the bladder to release the medication over time.

  • Intravesical Chemotherapy

    refers to cancer-fighting medications that are placed directly into the bladder through a catheter. These medications work to kill cancer cells in the bladder lining. The specific chemotherapy drug used will be chosen by the doctor based on what they think is best for each patient.

  • Bacillus Calmette-Guérin

    (BCG) is a treatment made from weakened bacteria that is placed directly into the bladder. It helps the body's immune system recognize and fight bladder cancer cells. Patients in this study will have already received this treatment before joining the trial.

What is already known about the treatment

TAR-210 Erdafitinib Intravesical Delivery System – This is a medication delivery system that is placed directly into the bladder through a catheter, where it slowly releases the drug erdafitinib over time. It is currently being tested in a Phase 3 clinical trial to evaluate its effectiveness and safety in treating high-risk bladder cancer that has not invaded the muscle layer, specifically in patients whose cancer has certain genetic changes called FGFR alterations and who have already received BCG treatment. Erdafitinib works by blocking specific proteins called fibroblast growth factor receptors (FGFR) that help cancer cells grow and multiply, and by delivering the medication directly into the bladder, it targets the cancer cells while minimizing effects on the rest of the body. This medication belongs to a class of drugs known as targeted therapy agents or FGFR inhibitors, which are designed to attack cancer cells with specific genetic characteristics.

Investigated diseases

High-risk Non-muscle-invasive Bladder Cancer – This is a type of bladder cancer where abnormal cells grow in the inner lining of the bladder but have not spread into the deeper muscle layer of the bladder wall. The cancer is considered high-risk because it has a greater chance of coming back after treatment or progressing to a more advanced stage. In this specific form, the cancer cells have changes in a gene called FGFR, which affects how cells grow and divide. The disease begins in the innermost layer of the bladder and may grow larger or spread across more of the bladder surface over time. Without proper management, these cancerous cells can eventually invade deeper into the bladder muscle. The presence of FGFR alterations makes the cancer cells susceptible to certain targeted approaches.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519493-39-00Protocol code42756493BLC3005Estimated enrolment220 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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