NCT07309445 · Janssen Research & Development, LLC
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
(Nova-sTAR)
What this study is about
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).
View original scientific description
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
- Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
- Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
- Must provide informed consent as described in the protocol
Exclusion criteria
- Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
- Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
- Previously received TAR-200 intravesically as part of a clinical trial(s)
- Previously received greater than (\>) 2 doses/cycles of TAR-200 in the real-world setting
- Currently participating in an interventional bladder cancer clinical trial
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Los Angeles, California
- Lakewood, Colorado
- Wimauma, Florida
- Indianapolis, Indiana
- St Louis, Missouri
- Syracuse, New York
- Charlotte, North Carolina
- Sioux Falls, South Dakota
- Arlington, Texas
- Spokane, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations