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Study of TAR-200 and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Not Undergoing Radical Cystectomy

Fast replyRegistered 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 Muscle-Invasive Bladder Cancer (MIBC). The study is evaluating a new treatment approach using a combination of two treatments: TAR-200 and Cetrelimab. TAR-200 is a device that delivers medication directly to the bladder, and Cetrelimab is a type of medication called a monoclonal antibody, which is designed to help the immune system fight cancer. The trial compares this combination to the standard treatment of chemoradiotherapy, which involves using chemotherapy and radiation therapy together.

The purpose of the study is to see if the combination of TAR-200 and Cetrelimab can help patients live longer without their cancer returning or spreading. Participants in the study will be randomly assigned to receive either the new combination treatment or the standard chemoradiotherapy. The study will last for several months, and participants will receive regular check-ups and monitoring to assess their health and the effectiveness of the treatment.

Throughout the study, participants will receive their treatments through intravenous infusions, which means the medication is given directly into a vein. The study aims to provide more information about the potential benefits and safety of using TAR-200 and Cetrelimab together for treating Muscle-Invasive Bladder Cancer. This research could lead to new treatment options for patients with this type of 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: one receiving the combination of TAR-200 and cetrelimab, and the other receiving concurrent chemoradiotherapy.

  3. Step 3

    Treatment administration

    For those in the TAR-200 and cetrelimab group, TAR-200 is administered intravesically, which means it is delivered directly into the bladder. Cetrelimab is given intravenously, meaning it is administered through a vein.

    For those in the chemoradiotherapy group, medications such as gemcitabine and cisplatin are administered intravenously. The specific dosage and frequency are determined by the study protocol and the patient's condition.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the patient's response to treatment and to identify any side effects. This includes physical examinations, imaging tests, and laboratory tests.

    Follow-up visits are scheduled at regular intervals to ensure the patient's well-being and to collect data on the treatment's effectiveness.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment. This includes a comprehensive review of the patient's health status and any changes in the condition of the bladder cancer.

  6. Step 6

    Long-term follow-up

    After the treatment phase, long-term follow-up is conducted to monitor the patient's health and to gather data on the long-term effects of the treatment. This may include periodic check-ups and additional tests as needed.

Who can join the trial?

10 criteria

  • Must be at least 18 years old or the legal age of consent in the area where the study is happening.
  • Must be willing and able to follow the lifestyle rules set by the study.
  • Must have a confirmed diagnosis of a specific type of bladder cancer called **urothelial carcinoma**. This diagnosis should have been made within 120 days before joining the study. Some other types of bladder cancer are allowed if the main type is urothelial carcinoma, but not if it includes small cell or neuroendocrine types.
  • Must not be eligible for or have chosen not to have a surgery called **radical cystectomy**, which removes the bladder.
  • Any side effects from previous surgeries or treatments must have improved to a mild level before joining the study.
  • Must have a certain level of physical ability, as measured by a scale called the **ECOG performance status**, with a score of 0, 1, or 2.
  • Thyroid function tests must be normal or stable if taking hormone supplements. A specialist may be consulted if the results are unclear.
  • Must have adequate function of the bone marrow, liver, and kidneys. This includes specific levels of blood cells, liver enzymes, and kidney function.
  • Must follow local rules for using birth control during the study and for 6 months after the last treatment. This includes not donating eggs or sperm and not planning to become pregnant or father a child during this time.
  • Must sign a form called an **Informed Consent Form** to show understanding of the study's purpose and agree to participate, including storing samples if needed.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have a serious infection that is not controlled or treated.
  • Patients who have a history of severe allergic reactions to any of the drugs used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a condition that affects their immune system, like HIV or AIDS.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of heart problems, such as a heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • TAR-200

    is a medication being studied for its effectiveness in treating muscle-invasive urothelial carcinoma of the bladder. It is designed to be delivered directly to the bladder, where it can release the medication over time to target cancer cells.

  • Cetrelimab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is being tested in combination with TAR-200 to see if it improves treatment outcomes for patients with bladder cancer.

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 in treating muscle-invasive urothelial carcinoma of the bladder. The main therapeutic indication is for patients with this type of bladder cancer who are not undergoing radical cystectomy. TAR-200 works by continuously releasing a chemotherapy drug directly into the bladder, targeting cancer cells locally. It is classified as a drug delivery system designed to provide sustained release of medication.

  • Cetrelimab

    Cetrelimab is administered via intravenous infusion, allowing the medication to enter the bloodstream directly. It is currently under investigation in clinical trials for its potential to treat muscle-invasive urothelial carcinoma of the bladder. The primary therapeutic use is for patients with this bladder cancer type, particularly those not receiving radical cystectomy. Cetrelimab functions by blocking a specific protein that inhibits the immune system, thereby enhancing the body's ability to fight cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Muscle-Invasive Urothelial Carcinoma of the Bladder – This is a type of bladder cancer that begins in the urothelial cells lining the bladder and invades the muscle layer of the bladder wall. It is characterized by the presence of cancerous cells that have penetrated the muscularis propria, which is the muscle layer of the bladder. As the disease progresses, it may spread to nearby tissues and organs, including the lymph nodes and other parts of the body. Symptoms often include blood in the urine, frequent urination, and pain during urination. The disease can lead to significant changes in bladder function and may require interventions to manage its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507188-21-00Protocol code17000139BLC3001Estimated enrolment550 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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