Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study Comparing Erdafitinib and Mitomycin for Patients with Intermediate-risk Non-muscle Invasive Bladder Cancer with FGFR Gene Alterations

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

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 Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) that has specific changes in the FGFR gene. The study is comparing two treatments: a new system called TAR-210 that delivers the drug Erdafitinib directly into the bladder, and a single chemotherapy drug also given directly into the bladder. The chemotherapy drugs being studied are Mitomycin and Gemcitabine Hydrochloride. The purpose of the study is to see which treatment is more effective and safe for patients with this type of bladder cancer.

Participants in the study will be randomly assigned to receive either the TAR-210 system or one of the chemotherapy drugs. The study will last for up to 12 months, during which time the effects of the treatments will be monitored. The TAR-210 system uses a special device to place the medication directly into the bladder, which is a non-surgical procedure. The study aims to find out how long it takes for the cancer to return or worsen, or for any other serious health issues to occur.

This trial is important for understanding better treatment options for people with bladder cancer that has FGFR gene changes. By comparing these treatments, researchers hope to improve the management of this disease and provide more effective care for patients in the future.

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

    Joining the study

    Upon joining the study, a diagnosis of intermediate-risk non-muscle invasive bladder cancer with FGFR gene alterations is confirmed. This involves testing either through urine or tumor tissue.

    Visible papillary disease must be fully removed before starting the trial, and the absence of disease is confirmed through a screening procedure.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: Group A or Group B. This process is essential to compare the effectiveness of different treatments.

  3. Step 3

    Treatment administration

    Group A receives the TAR-210 erdafitinib intravesical delivery system. This involves administering the medication directly into the bladder.

    Group B receives a single agent intravesical chemotherapy, which could include mitomycin or gemcitabine hydrochloride, also administered directly into the bladder.

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular monitoring to assess the treatment's effectiveness and any side effects. This includes periodic check-ups and imaging tests.

    The primary goal is to measure the time from randomization to the first documented recurrence of bladder cancer, disease progression, or death from any cause.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by June 2028. Participants will be informed of the study's outcomes and any relevant findings related to their health.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of **Intermediate-risk Non-muscle Invasive Bladder Cancer** within 90 days before joining the study. This type of cancer affects the bladder but does not invade the muscle.
  • Must meet at least one of the following conditions:
    • Recurrent **Ta LG/G1**: This means the cancer has come back and is of a low grade.
    • Primary and multifocal **Ta LG/G1**: The cancer is new, low grade, and appears in multiple places.
    • Primary and **≥3 cm Ta LG/G1**: The cancer is new, low grade, and at least 3 centimeters in size.
    • Primary or recurrent **Ta G2**: The cancer is either new or has come back and is of a slightly higher grade.
    • Must have at least one of the following risk factors:
      • Multiple low-grade tumors.
      • A single low-grade tumor larger than 3 centimeters.
      • Early recurrence, meaning the cancer comes back within one year.
      • Frequent recurrence, meaning the cancer comes back more than once a year.
      • Recurrence after previous treatment inside the bladder.
      • Must have a specific change in the **FGFR** gene, which can be checked through urine or tumor tissue testing.
      • Any visible cancer must be completely removed before joining the study, and no disease should be present during a bladder examination called **cystoscopy**.
      • Both men and women can participate.
      • Participants must be adults, typically aged 18 and older.

Who cannot join the trial?

8 criteria

  • Patients with a different type of bladder cancer than the one being studied.
  • Patients who have a high risk of their cancer spreading or returning.
  • Patients who have had other types of cancer in the past, unless it was a type that is not likely to come back.
  • Patients who have had certain treatments for their cancer that might affect the study results.
  • Patients who have serious health problems that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who are participating in another clinical trial at the same time.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • TAR-210

    is a new treatment being tested for bladder cancer. It is designed to be delivered directly into the bladder. This method aims to target cancer cells more effectively and reduce side effects compared to traditional treatments. The study is looking at how well this treatment works for people with a specific type of bladder cancer that has certain genetic changes.

  • Erdafitinib

    is a medication used in this study to treat bladder cancer. It works by blocking certain proteins that help cancer cells grow. This medication is being tested to see if it can help stop the cancer from coming back or getting worse.

  • Intravesical Chemotherapy

    is a standard treatment for bladder cancer where chemotherapy drugs are placed directly into the bladder. This method helps to kill cancer cells in the bladder and is being used in the study to compare its effectiveness against the new treatment being tested.

What is already known about the treatment

Erdafitinib – Erdafitinib is administered through an intravesical delivery system, meaning it is delivered directly into the bladder. It is currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating intermediate-risk non-muscle invasive bladder cancer with FGFR alterations. The main therapeutic indication is for bladder cancer with specific genetic changes in the FGFR gene. Erdafitinib works by inhibiting the activity of the fibroblast growth factor receptor (FGFR), which is involved in cell growth and division. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by cancer cells that are found in the tissue lining the inside of the bladder but have not spread into the muscle layer. It is often detected at an early stage and can vary in risk from low to high, depending on factors like tumor size and grade. The disease may cause symptoms such as blood in the urine, frequent urination, or pain during urination. Over time, if not managed, it can progress to muscle-invasive bladder cancer, which is more serious. Monitoring and regular check-ups are crucial to manage the disease and prevent progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507684-19-00Protocol code42756493BLC3004Estimated enrolment648 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).