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Study of erdafitinib versus chemotherapy (gemcitabine or mitomycin) for patients with high-risk non-muscle-invasive bladder cancer with FGFR mutations who failed BCG therapy

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 focuses on Non-Muscle-Invasive Bladder Cancer (NMIBC) that has specific genetic changes called FGFR mutations or fusions. The cancer being studied has returned after previous treatment with Bacillus Calmette-Guérin (BCG). The study compares two different treatments: an oral medication called erdafitinib (also known as JNJ-42756493) and standard chemotherapy medications (gemcitabine or mitomycin) that are placed directly into the bladder.

The main purpose of this research is to determine how well erdafitinib works compared to standard chemotherapy in preventing cancer from returning in patients with high-risk bladder cancer. The study will track how long patients remain free from cancer recurrence after starting treatment.

During the study, patients will be randomly assigned to receive either erdafitinib tablets taken by mouth, or chemotherapy treatment delivered directly into the bladder. The erdafitinib group will take the medication daily for up to 24 months. Patients receiving bladder chemotherapy will get treatment over a period of up to 7 days. The study will continue until early 2025.

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 and medication group assignment

    Your bladder cancer type and genetic markers will be checked to confirm eligibility for the study

    You will be randomly assigned to receive either erdafitinib tablets or intravesical chemotherapy (medication delivered directly into the bladder)

  2. Step 2

    Treatment pathway A - Erdafitinib tablets

    If assigned to erdafitinib, you will take tablets by mouth daily

    Regular blood tests will monitor your liver and kidney function

    Your phosphate levels will be checked regularly

  3. Step 3

    Treatment pathway B - Intravesical chemotherapy

    If assigned to intravesical therapy, you will receive either gemcitabine or mitomycin

    The medication will be delivered directly into your bladder through a small tube

    Treatment sessions will be scheduled according to your specific care plan

  4. Step 4

    Regular monitoring

    Regular bladder examinations (cystoscopy) will check for cancer recurrence

    Blood tests will monitor your overall health

    Your doctor will assess how well the treatment is working

  5. Step 5

    Study completion

    The study continues until February 2025

    Your participation may end earlier if your cancer returns or if you experience significant side effects

    Final assessment will evaluate how long you remained free of cancer recurrence

Who can join the trial?

10 criteria

  • Must be at least 18 years of age or meet the legal age of consent
  • Must have confirmed recurring bladder cancer that has not invaded the muscle layer (called non-muscle-invasive bladder cancer)
  • Must have specific genetic changes (mutations or fusions) in the FGFR gene confirmed by testing
  • Must have previously received treatment with BCG therapy (a type of bladder cancer treatment) and either: - Had cancer return within 12 months after treatment, or - Had cancer return within 6 months after treatment, or - Had signs of cancer after the first treatment course
  • Must either refuse or not be eligible for surgery to remove the bladder (called cystectomy)
  • Must be able to perform daily activities with minimal or no assistance (ECOG performance status of 0 or 1)
  • Must have adequate blood test results showing proper function of: - Bone marrow - Liver - Kidneys
  • Must sign an informed consent form showing understanding of the study
  • For women who can become pregnant: - Must have a negative pregnancy test within 7 days before starting the study - Must use effective birth control methods
  • For men with partners who can become pregnant: - Must use effective birth control methods during the study

Who cannot join the trial?

14 criteria

  • Age below 18 years old
  • Previous treatment with FGFR inhibitors (medications that block specific proteins involved in cancer growth)
  • Known allergies or hypersensitivity to the study medication or its components
  • Presence of muscle-invasive bladder cancer (cancer that has grown into the muscle wall of the bladder)
  • Significant heart problems, including uncontrolled high blood pressure or recent heart attack
  • Severe kidney or liver problems
  • Active or untreated infections
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Mental conditions that could interfere with following study procedures
  • History of other cancers in the past 2 years (except for successfully treated non-melanoma skin cancer)
  • Absence of FGFR mutations or fusions (specific genetic changes in the tumor)
  • Unable to provide informed consent
  • Medical conditions that could interfere with study procedures or interpretation of results
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Investigated drugs

  • Erdafitinib

    is a targeted therapy medication that works by blocking specific proteins called FGFR (fibroblast growth factor receptors) in cancer cells. It is used to treat bladder cancer that has specific genetic mutations or fusions in the FGFR genes. This medication is taken orally and works by helping to stop or slow down the growth of cancer cells.

  • Bacillus Calmette-Guérin (BCG)

    is a type of immunotherapy used to treat bladder cancer. It is made from a weakened form of bacteria and is delivered directly into the bladder through a catheter. BCG works by stimulating the immune system to fight cancer cells in the bladder.

  • Intravesical chemotherapy

    refers to chemotherapy drugs that are placed directly into the bladder through a catheter. This type of treatment delivers medication directly to the tumor site while minimizing exposure to the rest of the body, which helps reduce side effects.

What is already known about the treatment

  • Erdafitinib

    An oral targeted therapy medication used in the treatment of bladder cancer, specifically for patients with FGFR (Fibroblast Growth Factor Receptor) genetic alterations. This drug works by blocking FGFR signaling pathways that contribute to cancer growth, and it's being studied in clinical trials for high-risk and intermediate-risk non-muscle-invasive bladder cancer (NMIBC) patients who have previously received BCG therapy. Erdafitinib belongs to the class of drugs known as tyrosine kinase inhibitors and represents a personalized medicine approach, as it specifically targets cancers with FGFR mutations or fusions.

  • BCG (Bacillus Calmette-Guérin)

    An intravesical immunotherapy medication administered directly into the bladder through a catheter for the treatment of non-muscle-invasive bladder cancer. This therapy uses a weakened form of bacteria to stimulate the immune system to fight cancer cells, and it is considered a standard first-line treatment for high-risk bladder cancer. BCG works by triggering a local immune response in the bladder tissue, helping to prevent cancer recurrence and progression.

Investigated diseases

  • Non-Muscle-Invasive Bladder Cancer (NMIBC)

    A type of bladder cancer that affects the inner lining of the bladder without invading the muscle layer. The cancer cells are found only in the bladder's inner lining and connective tissue layer. NMIBC can occur with genetic changes called FGFR mutations or fusions, which affect how cells grow and divide. The condition can be classified into different risk levels (high-risk and intermediate-risk) based on specific characteristics of the tumor. The cancer may recur in the bladder after initial treatment.

  • FGFR-Mutated Bladder Cancer

    A form of bladder cancer characterized by specific genetic alterations in the Fibroblast Growth Factor Receptor (FGFR) genes. These mutations affect the way cells receive growth signals and can influence how the cancer develops. The presence of FGFR mutations or fusions represents a distinct molecular subtype of bladder cancer. This genetic profile can occur in both high-risk and intermediate-risk cases of bladder cancer.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510306-40-00Protocol code42756493BLC2003Estimated enrolment34 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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