Active not recruitingPHASE3INTERVENTIONAL

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

This research study is for people with a specific type of bladder cancer called high-risk non-muscle invasive bladder cancer (HR-NMIBC). This means the cancer is in the lining of the bladder but hasn't grown into the bladder muscle. The study wants to find out if new treatments, TAR-200 (a small device that releases a drug in the bladder) alone or combined with Cetrelimab (an injection that helps your immune system), are better or safer than the standard treatment, a liquid called BCG that is put into the bladder. Participants in the study haven't had BCG treatment before. Researchers will closely watch how well these treatments work, their side effects, and how they affect the body over about five years.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

1,135

Start

23 Mar 2023

Estimated completion

18 Sep 2029

Bladder Cancer

What is this study about?

If you have bladder cancer that hasn't grown into the bladder muscle (called high-risk non-muscle invasive bladder cancer, or HR-NMIBC), doctors are looking for better ways to treat it. This type of cancer is quite common, and while the usual treatment, BCG, often works, researchers are always trying to find new options.

This study is comparing three different approaches. One group will receive BCG, which is a liquid medicine that's put directly into your bladder. Another group will get TAR-200, which is a small device placed in your bladder that slowly releases a drug called gemcitabine over time. The third group will receive TAR-200 along with an injection of Cetrelimab, a drug aimed at boosting your body's own immune system to fight the cancer.

The main goal is to see if TAR-200, alone or with Cetrelimab, can keep the cancer from coming back or worsening for longer than BCG. The study will also carefully check for any side effects and how these treatments affect your body. Your participation would help doctors understand the best way to treat this type of bladder cancer in the future.

Key takeaways

This study compares new bladder cancer treatments (TAR-200 alone or with Cetrelimab) with standard BCG.
It's for a specific type of bladder cancer that hasn't spread into the bladder muscle.
Participants must not have had BCG treatment before, or not in the last 3 years.
The study aims to see which treatment best prevents cancer recurrence and is safest.
Taking part means regular visits and tests over several years.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older with a specific type of bladder cancer. To join, your cancer must be high-risk but hasn't grown into the muscle of your bladder. Importantly, you must not have received the BCG treatment for bladder cancer before, or if you did, it must have been more than three years ago.

Before you start, any visible growths in your bladder must have been completely removed. Doctors will also check your general health and how well you can go about your daily activities. You must be willing to have all the study tests and procedures.

There are also reasons you wouldn't be able to join. For example, if your bladder cancer has spread into the muscle or to other parts of your body, or if you have certain other types of cancer. You also can't have any bladder problems that would make it difficult to use the study treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high-risk bladder cancer that hasn't spread into the bladder muscle?
Have you never had BCG bladder treatment before (or not in the last 3 years)?
Have any visible bladder growths been completely removed?
Are you generally well enough to go about your daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll go through several stages. First, there's a 'screening' phase where tests confirm you're suitable for the study. If you qualify, you'll be assigned to one of the three treatment groups (TAR-200 alone, TAR-200 plus Cetrelimab, or BCG). The treatments will be given at specific times as decided by the study doctors.

Throughout the study, you'll have regular hospital visits for assessments. These will include checking how well you are, blood tests, urine tests, bladder examinations using a scope (cystoscopy), and other investigations to monitor your health, how the treatment is working, and any side effects. The total time you'll be involved in the study could be up to 5 years and 2 months, including the treatment and a follow-up period to see how you're doing long-term.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than standard care, or you might gain closer medical attention than you would otherwise. However, there's no guarantee the treatment will work for you, and you might experience side effects from the study drugs, some of which could be serious. All treatments carry known and unknown risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (240)

Mayo Clinic
Verified postcode
Scottsdale, United States
Arkansas Urology
Verified postcode
Little Rock, United States
VA Long Beach Health Care System
Verified postcode
Long Beach, United States
Genesis Research, LLC - West Coast Urology
Verified postcode
Los Alamitos, United States
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
UC Davis Comprehensive Cancer Center
Verified postcode
Sacramento, United States
Genesis Research
Verified postcode
San Diego, United States
Providence Saint Johns Cancer Institute
Verified postcode
Santa Monica, United States
Providence Medical Foundation
Verified postcode
Santa Rosa, United States
Colorado Clinical Research
Verified postcode
Lakewood, United States
Urological Research Network
Verified postcode
Hialeah, United States
Orlando Health Cancer Institute
Verified postcode
Orlando, United States

Common questions

What is 'non-muscle invasive bladder cancer'?

This means the cancer is only in the inner lining of your bladder and hasn't grown into the bladder muscle.

What is BCG treatment?

BCG is a liquid medicine, usually put into your bladder, that helps your immune system fight bladder cancer cells.

What is TAR-200?

TAR-200 is a small device placed in your bladder that slowly releases a drug over time to treat the cancer.

What is Cetrelimab?

Cetrelimab is a drug given by injection that works with your body's immune system to help it fight cancer.

How long will the study last?

The study could last for about five years and two months, including treatment and follow-up checks.