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
A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US
1 other identifier
observational
150
1 country
16
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2026
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2025
CompletedFirst Posted
Study publicly available on registry
December 30, 2025
CompletedStudy Start
First participant enrolled
June 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 9, 2029
July 31, 2026
July 1, 2026
2.8 years
December 16, 2025
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival (DFS)
DFS is defined as the time from first TAR-200 initiation date to the time of the first recurrence of NMIBC (Ta, any T1 or carcinoma in-situ \[CIS)\], progression (to muscle invasive bladder cancer \[MIBC; T greater than or equal to {\>=} 2\] or to lymph node \[N+\] or to distant disease \[M+\], whichever occurs first), or death due NMIBC, whichever occurs first.
Up to 24 months
Secondary Outcomes (20)
Complete Response (CR) Rate
At 3, 6, 12, 18, and 24 months
Duration of Response (DOR)
Up to 24 months
Overall Survival (OS)
Up to 24 months
Cancer-Specific Survival (CSS)
Up to 24 months
Time to Next Treatment (TTNT)
Up to 24 months
- +15 more secondary outcomes
Study Arms (1)
NMIBC Participants: Routine Clinical Practice Setting
Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study.
Eligibility Criteria
Participants aged 18 years or above with confirmed diagnosis of NMIBC (based on transurethral resection of bladder tumor \[TURBT\] or cold cup biopsy), who initiated the first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1 and willing to provide informed consent will be enrolled into the study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Florida Urology Partners
Wimauma, Florida, 33598, United States
Associated Urological Specialists
Chicago Ridge, Illinois, 60415, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Specialty Clinical Research of St Louis
St Louis, Missouri, 63141, United States
SUNY Upstate Med Univ
Syracuse, New York, 13210, United States
Urology Specialists of the Carolinas PLLC Charlotte
Charlotte, North Carolina, 28204, United States
Low Country Urology Clinics
North Charleston, South Carolina, 29406, United States
Urology Specialists of South Dakota
Sioux Falls, South Dakota, 57108, United States
UPNT Research Institute
Arlington, Texas, 76017, United States
Spokane Urology
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2025
First Posted
December 30, 2025
Study Start
June 12, 2026
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
October 9, 2029
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.