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Study on TAR-200 and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for or Refusing Platinum-Based Chemotherapy

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 Muscle-Invasive Urothelial Carcinoma. The study is exploring the effects of two treatments: a combination of TAR-200 and Cetrelimab, and Cetrelimab alone. TAR-200 is a device that helps deliver medication directly into the bladder, while Cetrelimab is a type of medication known as a monoclonal antibody, which is designed to help the immune system fight cancer cells.

The purpose of the study is to understand how these treatments can affect the tumor in patients who are scheduled for a surgery called radical cystectomy, which involves removing the bladder. The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants in the study are those who cannot or choose not to receive a type of chemotherapy known as platinum-based chemotherapy before surgery.

Participants will be randomly assigned to one of two groups: one group will receive the combination of TAR-200 and Cetrelimab, and the other group will receive Cetrelimab alone. The study will monitor the effects of these treatments over a period of time to see how well they work in reducing the cancer before surgery. The study will also look at the safety of the treatments and any side effects that may occur. The goal is to gather information that could help improve treatment options for this type of bladder cancer in the future.

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

    Initial assessment and randomization

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Participants are then randomly assigned to one of two groups: one receiving TAR-200 in combination with cetrelimab, and the other receiving cetrelimab alone.

  2. Step 2

    Treatment administration

    Participants in the first group receive TAR-200 via intravesical use, which involves administering the medication directly into the bladder.

    Both groups receive cetrelimab through intravenous infusion. This involves administering the medication directly into a vein.

    The treatment schedule and dosage are determined by the study protocol and are administered under medical supervision.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical examinations, blood tests, and imaging studies.

    Participants are required to attend scheduled follow-up visits to ensure ongoing evaluation of their health status and treatment effects.

  4. Step 4

    Surgical procedure

    Participants undergo a surgical procedure known as radical cystectomy, which involves the removal of the bladder. This is a planned part of the study for all participants.

    The primary goal is to evaluate the complete response rate at the time of surgery.

  5. Step 5

    Post-surgery evaluation

    After surgery, participants continue to be monitored for any adverse events and recovery progress.

    Additional assessments are conducted to evaluate recurrence-free survival and any laboratory abnormalities.

Who can join the trial?

13 criteria

  • Must be at least 18 years old or the legal age of consent in the study location.
  • Any side effects from previous surgeries must have improved to a mild level before joining the study.
  • Participants must follow local rules for using birth control during the study. Women must not be pregnant, breastfeeding, or planning to become pregnant during the study and for 6 months after the last treatment. Men must use condoms during the study and for 6 months after the last treatment.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
  • Must sign an informed consent form, or a legal representative must sign it on their behalf.
  • Must have a confirmed diagnosis of **Muscle-Invasive Urothelial Carcinoma of the Bladder** within 120 days before joining the study. This is a type of bladder cancer.
  • Participants with no remaining tumor or a tumor size of 3 cm or less after a procedure called **TURBT** (a surgery to remove bladder tumors) can join. If the tumor is larger than 3 cm, another surgery is needed to reduce its size.
  • Must be eligible and willing to undergo **RC** (removal of the bladder) as determined by a urologist.
  • Must have a good performance status, meaning they can carry out daily activities without help.
  • Thyroid function must be normal or stable with medication.
  • Must have adequate bone marrow, liver, and kidney function.
  • Must refuse or be ineligible for **cisplatin-based chemotherapy** (a type of cancer treatment) due to specific health reasons like poor kidney function, hearing loss, or nerve damage.
  • Previous chemotherapy for other conditions is allowed if it was more than 24 months ago and any side effects have improved to a mild level.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had a recent major surgery or procedure.
  • Patients who are currently receiving another cancer treatment.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend required visits.
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Investigated drugs

  • TAR-200

    is a medication being studied for its potential to treat muscle-invasive urothelial carcinoma of the bladder. It is designed to be used in combination with another medication to see if it can help reduce the size of tumors or slow their growth in patients who are not able to receive or choose not to receive standard chemotherapy.

  • Cetrelimab

    is another medication involved in this study. It is being tested both on its own and in combination with TAR-200. Cetrelimab is an immunotherapy drug, which means it works by helping the body's immune system recognize and attack cancer cells. The study aims to see how effective Cetrelimab is in treating bladder cancer, either alone or when used with TAR-200.

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 potential use in treating muscle-invasive urothelial carcinoma of the bladder. The main therapeutic indication is to provide localized treatment for bladder cancer, particularly for patients who are not candidates for or refuse platinum-based chemotherapy. TAR-200 works by delivering a sustained release of medication directly to the bladder, targeting cancer cells more effectively. It is classified as a localized drug delivery system.

  • Cetrelimab

    Cetrelimab is administered via intravenous infusion. It is an investigational medication currently being evaluated in clinical trials for its effectiveness in treating muscle-invasive urothelial carcinoma of the bladder. The primary therapeutic indication is to enhance the body's immune response against cancer cells. Cetrelimab functions as a checkpoint inhibitor, blocking proteins that prevent the immune system from attacking cancer cells. It belongs to the class of immunotherapy drugs known as monoclonal antibodies.

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 into the muscle layer of the bladder wall. It is characterized by the growth of cancerous cells that can spread to nearby tissues and organs. As the disease progresses, it may cause symptoms such as blood in the urine, frequent urination, and pain during urination. The cancer can also lead to more severe symptoms if it spreads beyond the bladder. The progression of this disease often requires medical intervention to manage its impact on the bladder and surrounding areas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507189-17-00Protocol code17000139BLC2002Estimated enrolment160 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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