This clinical trial is focused on studying a type of bladder cancer known as High-Risk Non-Muscle Invasive Bladder Cancer (HRNMIBC). The study is evaluating the effectiveness and safety of a treatment called TAR-200, both on its own and in combination with another treatment called Cetrelimab, compared to a standard treatment known as Bacillus Calmette-Guérin (BCG). TAR-200 is a device that delivers medication directly to the bladder, while Cetrelimab is a type of medication known as a monoclonal antibody, which is a protein designed to help the immune system fight cancer.
The purpose of the study is to compare how well these treatments work in preventing the return or worsening of the cancer. Participants in the study will be divided into groups to receive either TAR-200 with Cetrelimab, TAR-200 alone, or the standard BCG treatment. The study will monitor participants over time to see how long they remain free from cancer recurrence or progression.
Throughout the study, participants will undergo various procedures, including regular check-ups and tests to assess their health and the status of their cancer. The study aims to provide valuable information on the potential benefits of these new treatment options for people with High-Risk Non-Muscle Invasive Bladder Cancer.
1initial treatment phase
Upon joining the study, participants are randomly assigned to one of three groups. Group A receives a combination of TAR-200 and cetrelimab, Group B receives intravesical BCG, and Group C receives TAR-200 alone.
TAR-200 is a device that releases medication directly into the bladder. Cetrelimab is administered through an intravenous infusion, which means it is given directly into a vein.
The BCG vaccine is administered directly into the bladder through a catheter, a process known as intravesical use.
2treatment administration
Participants in Group A receive TAR-200 and cetrelimab. TAR-200 is placed in the bladder every three weeks, while cetrelimab is given as an intravenous infusion every four weeks.
Participants in Group B receive the BCG vaccine intravesically once a week for six weeks, followed by maintenance doses.
Participants in Group C receive TAR-200 alone, which is placed in the bladder every three weeks.
3monitoring and follow-up
Throughout the study, participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.
This includes cystoscopies, which are procedures that allow doctors to look inside the bladder, and bladder biopsies, which involve taking small samples of bladder tissue for examination.
Participants are monitored for event-free survival, which means the time until the first recurrence of high-risk disease, progression, or death from any cause.
4end of study
The study is expected to conclude by May 31, 2028. At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of the treatments.
Participants will have a final assessment to evaluate their health status and any long-term effects of the treatment.
Who Can Join the Study?
Participants must be 18 years or older or the legal age of consent in the area where the study is conducted.
Participants must have a confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 90 days of signing the consent form. This includes high-grade papillary Ta, any T1, or carcinoma in situ (CIS). Mixed tumor types are allowed if the main type is urothelial (transitional cell) but not if they have certain other features like neuroendocrine or micropapillary.
Participants must be BCG-naïve, meaning they have not received the BCG treatment before, or if they have, it was more than 3 years ago.
Participants must be willing to undergo all study procedures, including multiple bladder examinations and biopsies to check for cancer recurrence or progression.
All visible papillary disease must be completely removed before joining the study, and initial urine tests must be negative or atypical for certain cancer cells if there is no CIS.
Any side effects from previous surgeries or treatments must have improved to a mild level before joining the study.
Participants must have an ECOG performance status of 0, 1, or 2, which is a measure of their ability to perform daily activities.
Thyroid function tests must be normal or stable as assessed by the study doctor. If the results are unclear, a thyroid specialist may be consulted.
Who Cannot Join the Study?
Patients who have had previous treatment with BCG (Bacillus Calmette-Guérin), a type of therapy used for bladder cancer.
Patients with muscle-invasive bladder cancer, which means the cancer has spread into the muscle layer of the bladder.
Patients with any other type of cancer that is currently being treated or has been treated in the past 5 years, except for certain skin cancers.
Patients with severe or uncontrolled medical conditions that could interfere with the study or pose a risk to the patient.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or comply with the study requirements.
Patients with a history of severe allergic reactions to any of the study drugs or similar drugs.
Patients with active infections that require treatment with antibiotics or other medications.
Patients with a compromised immune system, which means their body’s defense system is weakened.
Patients who have participated in another clinical trial within the last 30 days.
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 into the bladder, where it can release the medication over time to target cancer cells.
Cetrelimab is an investigational medication that is being tested in combination with TAR-200. It is administered intravenously and works by helping the immune system recognize and attack cancer cells.
Bacillus Calmette-Guérin (BCG) is a standard treatment for bladder cancer that involves placing a solution containing weakened bacteria directly into the bladder. This treatment is intended to stimulate the immune system to fight cancer cells in the bladder.
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 its potential to recur or progress to a more invasive form. The disease may present as high-grade papillary tumors, carcinoma in situ (CIS), or any T1 stage tumors. Over time, if not managed, it can progress from a superficial stage (Ta) to a more invasive stage (T1) or even to muscle-invasive bladder cancer (MIBC). The progression can also involve spreading to lymph nodes or distant organs. Monitoring and management are crucial to prevent advancement to more severe stages.
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