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Study on TAR-200 and Cetrelimab for High-Risk Bladder Cancer Patients Not Responding to BCG and Unable or Unwilling to Have Surgery

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). This form of cancer affects the bladder but does not invade the muscle layer. The study is exploring the effectiveness and safety of different treatments for patients whose cancer has not responded to a common treatment called Intravesical Bacillus Calmette-Guérin (BCG) and who are not eligible for or have chosen not to undergo a major surgery called radical cystectomy. The treatments being tested include a drug-device combination called TAR-200, which is placed in the bladder, and a medication called Cetrelimab, which is given through an infusion into the vein. The study will look at these treatments both separately and in combination.

The purpose of the study is to evaluate how well these treatments work in eliminating cancer and preventing its return. Participants will be divided into different groups to receive either TAR-200 with Cetrelimab, TAR-200 alone, or Cetrelimab alone. The study will also include a group receiving TAR-200 alone for those with a specific type of papillary disease. Throughout the study, participants will undergo regular check-ups, including procedures like cystoscopies, which allow doctors to look inside the bladder, and biopsies, which involve taking small samples of tissue for examination. These procedures help in assessing the response to the treatment and monitoring any changes in the condition.

The study will last for several years, with participants receiving treatment over a period of time and being monitored for any signs of cancer recurrence or progression. The trial aims to provide valuable information on the potential benefits and safety of these treatments for patients with high-risk NMIBC. By participating, individuals contribute to research that may improve future treatment options for this type of bladder cancer.

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, the participant will be assigned to one of the treatment groups based on their specific medical condition and eligibility criteria.

    The study involves participants with high-risk non-muscle invasive bladder cancer that has not responded to previous treatments.

  2. Step 2

    Treatment assignment

    Participants will be assigned to one of the following treatment groups: TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone.

    The treatment involves the use of medications administered either directly into the bladder or through an intravenous infusion.

  3. Step 3

    Medication administration

    For those receiving TAR-200, the medication is administered intravesically, meaning it is placed directly into the bladder.

    Participants receiving cetrelimab will have it administered intravenously, which involves an infusion into a vein.

  4. Step 4

    Monitoring and follow-up

    Participants will undergo regular monitoring to assess the response to the treatment. This includes cystoscopies, which are procedures to look inside the bladder, and urine tests.

    The study will also monitor for any side effects or adverse reactions to the medications.

  5. Step 5

    Evaluation of treatment effectiveness

    The effectiveness of the treatment will be evaluated by measuring the absence of high-grade disease through cystoscopy and urine tests.

    Participants will be assessed for the duration of their response to the treatment and overall survival rates.

  6. Step 6

    Completion of the study

    The study is expected to continue until November 2027, with participants being followed up throughout this period.

    Upon completion, the data collected will be analyzed to determine the overall success and safety of the treatments.

Who can join the trial?

16 criteria

  • Must be at least 18 years old, or the legal age of consent in the area where the study is conducted.
  • Must have proper functioning of the bone marrow, liver, and kidneys. This includes a creatinine clearance greater than 30 mL/min, which is a measure of kidney function.
  • Must follow local rules for using birth control methods during the study. This includes:
    • Women who can have children must either not be able to have children, practice true abstinence, have a partner who has had a vasectomy, or use a highly effective birth control method. They must continue this for 6 months after the last dose of the study treatment.
    • Women must not donate eggs or plan to become pregnant during the study and for 6 months after the last dose.
    • Men must use a condom during any activity that could lead to pregnancy and continue this for 6 months after the last dose. If their partner can have children, she must also use a highly effective birth control method.
    • Men must not donate sperm or plan to father a child during the study and for 6 months after the last dose.
    • Women who can have children must have a negative pregnancy test before starting the study and agree to further tests during the study.
    • Must be willing and able to follow the lifestyle restrictions required by the study.
    • Must have a confirmed diagnosis of a specific type of bladder cancer, known as **high-risk non-muscle-invasive bladder cancer (HRNMIBC)**, within 12 months after completing a treatment called BCG therapy.
    • All visible cancer must be removed before starting the study, except for certain types of cancer that are allowed for specific groups in the study.
    • Must be willing to undergo all study procedures, including multiple bladder examinations and biopsies.
    • Must not be eligible for or have chosen not to undergo a surgery called radical cystectomy, which involves removing the bladder.
    • Must have a type of bladder cancer that did not respond to BCG therapy, even after receiving an adequate amount of this treatment.
    • Any side effects from previous surgeries or treatments must have improved to a mild level before starting the study.
    • Must sign a consent form indicating understanding of the study's purpose and procedures and agree to store samples if needed.
    • Must have an **ECOG performance status** of 0, 1, or 2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of bladder cancer than the one being studied.
  • Patients who have had a recent major surgery or procedure that might affect the study results.
  • Patients who have another serious medical condition that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an allergy or severe reaction to the study drugs.
  • Patients who have a history of certain heart conditions.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

  • TAR-200

    is a medication being studied for its effectiveness in treating high-risk non-muscle invasive bladder cancer. It is designed to be delivered directly to the bladder, where it can release the medication over time to target cancer cells. This approach aims to provide a continuous treatment to the affected area, potentially improving outcomes for patients who have not responded to other treatments.

  • Cetrelimab

    is an investigational medication used in this trial to help the body's immune system fight cancer. It is administered through an intravenous (IV) infusion. Cetrelimab works by blocking a specific protein that can prevent the immune system from attacking cancer cells, thereby enhancing the body's natural ability to combat the disease.

What is already known about the treatment

  • TAR-200

    TAR-200 is administered directly into the bladder, where it releases medication over time to treat high-risk non-muscle-invasive bladder cancer. It is currently being studied in clinical trials to assess its effectiveness and safety, particularly for patients who have not responded to standard treatments like Bacillus Calmette-Guérin (BCG) and are not candidates for surgery. The main therapeutic indication is for bladder cancer that has not invaded the muscle layer. TAR-200 works by delivering a sustained release of chemotherapy directly to the bladder, targeting cancer cells locally. It is classified as a drug-device combination product.

  • Cetrelimab

    Cetrelimab is administered intravenously and is being evaluated in clinical trials for its potential to treat high-risk non-muscle-invasive bladder cancer. It is an investigational medication, primarily used for patients who have not responded to traditional therapies and are not suitable for surgery. Cetrelimab is designed to help the immune system recognize and attack cancer cells by blocking a specific protein that usually helps cancer cells evade immune detection. It belongs to the class of immune checkpoint inhibitors.

Investigated diseases

Non-Muscle-Invasive Urothelial Carcinoma of the Bladder – This is a type of bladder cancer that affects the urothelial cells lining the bladder but has not spread into the muscle layer. It is characterized by the presence of cancerous cells in the bladder lining, which can form tumors. The disease often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. It is classified based on the appearance and behavior of the tumors, which can be papillary or flat. The progression of the disease can vary, with some tumors remaining superficial while others may become more aggressive. Regular monitoring is essential to manage the condition and prevent progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506146-23-00Protocol code17000139BLC2001Estimated enrolment210 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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