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Study Comparing TAR-200 and Chemotherapy for Patients with High-Risk Non-Muscle-Invasive Bladder Cancer After 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 clinical trial is focused on studying a type of bladder cancer known as High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC). The study will evaluate the effectiveness and safety of a treatment called TAR-200 compared to other chemotherapy options chosen by the doctors involved in the study. Participants in this trial have previously received a treatment called Bacillus Calmette-Guérin (BCG) and have experienced a recurrence of their cancer. They are either not eligible for or have chosen not to undergo a surgical procedure called radical cystectomy, which involves removing the bladder.

The purpose of the study is to compare how long participants remain free from the disease after receiving the treatments. The study will involve the use of gemcitabine hydrochloride, which is a chemical substance used in chemotherapy, and mitomycin, another chemotherapy drug. These medications will be administered directly into the bladder, a method known as intravesical use. The study will also involve the use of a device called a urinary placement catheter, which helps deliver the treatment directly to the bladder.

Participants will be randomly assigned to receive either the TAR-200 treatment or the chemotherapy chosen by their doctor. The study will monitor the participants over a period to observe the recurrence of cancer, any progression of the disease, or any other significant health events. The trial aims to provide valuable information on the effectiveness of these treatments in managing HR-NMIBC and improving the quality of life for those affected by this condition.

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 recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) must be confirmed. This diagnosis should be made within 90 days of providing consent.

    All visible tumors must be completely removed before the study begins. Urine tests should not show any signs of high-grade cancer cells before starting the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the TAR-200 treatment or the investigator's choice of intravesical chemotherapy. This process ensures that each participant has an equal chance of receiving any of the treatments.

  3. Step 3

    Treatment administration

    The treatment involves the use of medications administered directly into the bladder, known as intravesical use. The medications used in this study include gemcitabine hydrochloride and mitomycin.

    The specific dosage, frequency, and duration of administration will be determined by the study protocol and the healthcare team overseeing the trial.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular assessments will be conducted to monitor the participant's health and the effectiveness of the treatment. These assessments may include urine tests, bladder biopsies, or imaging tests.

    The primary goal is to measure disease-free survival (DFS), which is the time from the start of the study to the first recurrence of cancer, progression, or death from any cause.

  5. Step 5

    Completion of the study

    The study is expected to continue until March 14, 2031. Participants will be monitored until the study's completion or until they meet any criteria for withdrawal from the study.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of **High-Risk Non-muscle-invasive Bladder Cancer** (HR-NMIBC) within 90 days before agreeing to participate. This type of cancer is found in the bladder but hasn't spread to the muscle.
  • Can have certain types of bladder cancer cells, but not neuroendocrine or small cell types.
  • All visible tumors must be completely removed before starting the study. Urine tests should not show signs of high-grade cancer cells.
  • Must have received at least 5 out of 6 doses of a treatment called **BCG**. This is a common treatment for bladder cancer.
  • The cancer must have come back within 12 months after the last BCG treatment.
  • Must not be able to have or choose not to have a surgery called **RC** (removal of the bladder).
  • Both men and women can participate.
  • Participants can be from vulnerable groups, which means they might need extra protection or care.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not related to the bladder.
  • Patients who have had a different type of cancer in the past 5 years, except for certain skin cancers.
  • Patients with serious heart problems, such as a recent heart attack or heart failure.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a major surgery in the last 4 weeks.
  • Patients with an active infection that requires treatment.
  • Patients with a known allergy to the study medication.
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Investigated drugs

  • TAR-200

    is a medication being studied for its effectiveness and safety in treating high-risk non-muscle-invasive bladder cancer. It is designed to be delivered directly into the bladder, where it can release the medication over time to target cancer cells. This approach aims to improve disease-free survival for patients who have previously received Bacillus Calmette-Guérin (BCG) treatment but have experienced a recurrence of their cancer.

  • Intravesical Chemotherapy

    refers to a treatment where chemotherapy drugs are placed directly into the bladder through a catheter. This method allows the medication to come into direct contact with the bladder lining, targeting cancer cells while minimizing exposure to the rest of the body. In this trial, the choice of specific chemotherapy drugs is determined by the investigator based on the patient's condition and previous treatments.

What is already known about the treatment

TAR-200 – TAR-200 is administered as an intravesical device, meaning it is placed directly into the bladder. It is currently being studied in clinical trials for its effectiveness and safety in treating high-risk non-muscle-invasive bladder cancer, particularly in patients who have previously received Bacillus Calmette-Guérin (BCG) therapy and have experienced a recurrence. The main therapeutic indication for TAR-200 is to improve disease-free survival in these patients. At the molecular level, TAR-200 works by delivering chemotherapy directly to the bladder, allowing for a sustained release of the drug to target cancer cells. It is classified pharmacologically as a localized chemotherapy delivery system.

Investigated diseases

High-Risk Non-muscle-invasive Bladder Cancer – This type of bladder cancer is characterized by cancer cells that are found in the tissue lining the bladder but have not spread into the muscle layer. It is considered high-risk due to factors such as the presence of high-grade tumors, carcinoma in situ, or tumors that have recurred after treatment. The disease often presents with symptoms like blood in the urine, frequent urination, or pain during urination. Over time, if not managed, it may progress to muscle-invasive bladder cancer, which is more serious. Monitoring and regular check-ups are crucial to detect any changes in the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507685-10-00Protocol code17000139BLC3004Estimated enrolment248 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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