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Study on UGN-102 (Mitomycin) for Treating Low Grade Non-Muscle Invasive Bladder Cancer in Patients at Intermediate Risk of Recurrence

Verified siteInvestigationalNo placebo
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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 Non-Muscle Invasive Bladder Cancer (NMIBC). The study is specifically looking at patients with low-grade NMIBC who are at an intermediate risk of the cancer coming back. The treatment being tested in this trial is called UGN-102 (Mitomycin), which is a solution administered directly into the bladder. The purpose of the study is to evaluate how effective and safe UGN-102 is in treating this type of bladder cancer.

Participants in the study will receive UGN-102 as a primary treatment to see if it can effectively remove the cancer. The study will follow a single-arm design, meaning all participants will receive the same treatment without a comparison group. The treatment period will last for a maximum of six weeks, and the participants will be monitored for any changes in their condition. The study will assess the cancer's response to the treatment at various points, including three months after the first dose.

Throughout the study, the safety of UGN-102 will be closely monitored by checking for any side effects or adverse reactions. Participants will undergo regular check-ups, including physical exams and laboratory tests, to ensure their well-being. The study aims to provide valuable information on the potential of UGN-102 as a treatment option for patients with low-grade NMIBC, helping to determine if it can effectively reduce or eliminate the cancer while maintaining a good safety profile.

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

    Joining the study

    Upon joining the study, you will receive detailed information about the trial and be asked to provide written consent. This consent confirms your understanding and willingness to comply with the study requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a physical examination. Routine laboratory tests will be performed to ensure adequate organ and bone marrow function.

  3. Step 3

    Treatment administration

    You will receive the study medication, UGN-102 (Mitomycin), as an intravesical solution. This means the medication is administered directly into the bladder. The exact dosage and frequency will be explained to you by the study team.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your response to the treatment. These visits will include cystoscopy, a procedure to examine the inside of your bladder, and urine tests to check for any signs of cancer recurrence.

  5. Step 5

    Three-month evaluation

    At the three-month mark, a comprehensive evaluation will be conducted to determine the effectiveness of the treatment. This will involve a detailed examination of your bladder and additional tests as needed.

  6. Step 6

    Ongoing monitoring

    If the treatment is successful, you will continue to be monitored for any signs of recurrence. This will involve periodic assessments and tests to ensure your continued health and safety.

Who can join the trial?

9 criteria

  • Capable of giving written informed consent, which means you understand the study and agree to follow its rules.
  • You must be at least 18 years old.
  • You have been diagnosed with Low-Grade Non-Muscle Invasive Bladder Cancer (LG NMIBC), confirmed by a specific type of biopsy within 8 weeks before the study starts.
  • You have a history of LG NMIBC that required treatment with a procedure called Transurethral Resection of Bladder Tumor (TURBT), but this refers to a past episode, not the current one.
  • You have an intermediate risk of the disease, which means you have one or two of the following: multiple tumors, a single tumor larger than 3 cm, or early/frequent recurrence (at least one occurrence of LG NMIBC within one year of the current diagnosis).
  • You have a negative result for High-Grade (HG) disease in a test called voiding cytology within 8 weeks before the study starts.
  • Your organs and bone marrow are functioning well, as shown by routine blood tests.
  • You are expected to live at least as long as the study lasts.
  • If you are a male or female participant, you must agree to use two effective forms of birth control during the study and for six months after treatment if you or your partner can have children.

Who cannot join the trial?

6 criteria

  • Patients with **Non-Muscle Invasive Bladder Cancer** cannot participate if they have other types of bladder cancer.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Patients with any other serious health conditions that could affect their safety or the study results cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who are participating in another clinical trial at the same time are not eligible.
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Investigated drugs

UGN-102 is a medication being studied for its ability to treat a type of bladder cancer called low-grade non-muscle-invasive bladder cancer. This medication is used as a primary treatment to help destroy cancer cells in the bladder. It works by being directly applied to the bladder, where it aims to eliminate the cancerous tissue without the need for surgery. The goal of using UGN-102 is to reduce the risk of the cancer coming back and to provide a non-surgical option for patients with this type of bladder cancer.

What is already known about the treatment

UGN-102 – UGN-102 is administered directly into the bladder through a catheter, a method known as intravesical therapy. It is currently being studied in clinical trials as a treatment for low-grade, non-muscle-invasive bladder cancer, specifically for patients at intermediate risk of recurrence. The medication works by delivering chemotherapy directly to the bladder, where it aims to destroy cancer cells. UGN-102 is classified as a chemoablative agent, meaning it uses chemical substances to remove or destroy tissue, in this case, targeting cancerous cells in the bladder.

Investigated diseases

Non-Muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer. It typically begins with the formation of small tumors on the bladder's inner surface. As the disease progresses, these tumors can grow in size and number, potentially leading to more severe symptoms. The progression is often monitored through regular cystoscopy, a procedure that allows doctors to view the inside of the bladder. Non-muscle invasive bladder cancer can recur after initial treatment, necessitating ongoing surveillance. The disease is generally considered less aggressive than muscle-invasive bladder cancer, but it requires careful management to prevent progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506680-34-00Protocol codeBL011Estimated enrolment240 patientsSponsorUrogen Pharma Ltd.

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