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Long‑Term Follow‑Up of Mitomycin (UGN‑103) Treatment in Patients with Recurrent Low‑Grade Intermediate‑Risk Non‑Muscle Invasive Bladder Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Non-Muscle Invasive Bladder Cancer, a type of bladder cancer that stays on the surface of the bladder lining and has not spread into the muscle layer. This condition is often low‑grade and can return after treatment. The medication being examined is UGN-103 (Mitomycin), which is delivered directly into the bladder (a method called intravesical administration) so the drug works where the tumor is located.

The main purpose is to collect long‑term data on how long the cancer stays gone after a complete response. Participants who have already shown a complete response will continue to be monitored with regular bladder checks and follow‑up visits over an extended period to assess the duration of response. No additional treatments are given as part of the study; it simply observes the lasting effect of the initial therapy.

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

    Enrollment and consent

    After you decide to join the rollover study, you will sign a consent form that explains the purpose of the research and your responsibilities.

    Your eligibility will be confirmed, including verification that you have an ongoing complete response to the previous treatment.

  2. Step 2

    Baseline assessment

    During your first study visit, a study staff member will review your medical history and conduct a physical examination.

    A cystoscopy (a small camera examination of the bladder) will be performed to document the current status of your bladder cancer.

  3. Step 3

    Administration of <b>ugn-103</b>

    You will receive a single dose of ugn-103, which contains the active substance mitomycin.

    The medication is supplied as an intravesical solution, meaning it is placed directly into the bladder through a thin tube.

    The dose is 75 mg (milligrams) of mitomycin, delivered in the solution that fills the bladder for a short period before it is drained.

  4. Step 4

    Regular follow‑up visits

    After the initial dose, you will attend scheduled clinic visits approximately every three months.

    Each visit includes a cystoscopy and other routine tests to check whether the cancer remains absent.

    The study team will record any changes and monitor the duration of response, which measures how long the cancer stays under control.

  5. Step 5

    Ongoing data collection

    At every visit, your test results and any side effects are entered into the study database.

    This information helps researchers understand the long‑term durability of the response to ugn-103.

  6. Step 6

    Final study assessment

    The study is planned to continue until february 25, 2032, after which a final evaluation will be performed.

    During the final visit, a comprehensive review of all collected data will be completed to determine the overall outcome of the study.

Who can join the trial?

5 criteria

  • You have signed a written informed consent form, which means you understand the study and agree to take part.
  • You completed the earlier trial called Study BL013 and still have an ongoing complete response (the cancer signs are no longer detectable).
  • You have non‑muscle invasive bladder cancer, a type of bladder cancer that has not spread into the muscle of the bladder.
  • You can be either male or female; both genders are allowed in the study.
  • Your age falls within the range allowed for the trial (the study includes adult participants).

Who cannot join the trial?

2 criteria

  • Did not give written informed consent (the signed permission needed to join the study) for the rollover protocol (the follow‑up part of the study after the first trial).
  • Did not finish the previous Study BL013 while still having a complete response (CR) – meaning the cancer was fully gone and staying that way.
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Investigated drugs

UGN-103 (Mitomycin) is a chemotherapy medicine that is placed directly into the bladder (intravesical use). It works by stopping the growth of cancer cells that may be present in the bladder lining. In this study, participants who had already shown a complete response to the medicine in an earlier trial continued to be followed to see how long the benefit lasted after treatment with UGN-103.

What is already known about the treatment

UGN-103 (Mitomycin) - It is supplied as an intravesical solution that is poured directly into the bladder through a catheter, allowing the drug to act locally where the tumor is. Mitomycin is an established chemotherapy agent that has been used for many years and is well documented in medical literature. It is mainly used to treat non‑muscle invasive bladder cancer after tumor removal. The drug works by attaching to DNA inside cancer cells, blocking their ability to copy genetic material and causing the cells to die, and it is classified as an antitumor antibiotic.

Investigated diseases

Non‑Muscle Invasive Bladder Cancer - Non‑muscle invasive bladder cancer is a type of bladder cancer that remains limited to the inner lining and shallow layer of the bladder wall. It often causes blood in the urine or a feeling of urgency. The tumor grows on the surface of the bladder and may extend into the lamina propria but does not penetrate the muscle layer. Over time the disease can recur, with new tumors appearing in the same region. If it progresses, it may eventually involve the muscle layer, changing its classification. Ongoing monitoring looks for any new growths or changes in the bladder lining.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526359-75-00Protocol codeUGN-103-401Estimated enrolment59 patientsSponsorUrogen Pharma Ltd.

sourced from the EU Clinical Trials Register and site verification

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