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

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).

Study Overview

• Status: Recruiting
• Conditions: Non-Muscle Invasive Bladder Neoplasms

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com
• Study Contact Backup: Name: Eliza M. Raymundo, MD, DMCC, FPUA, FPCS; Phone Number: 1-669-800-7705

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Urology
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Norris Comprehensive Cancer Center
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Colorado Clinical Research
  • Florida
    • Wimauma, Florida, United States, 33598
      • Recruiting
      • Florida Urology Partners
  • Illinois
    • Chicago Ridge, Illinois, United States, 60415
      • Recruiting
      • Associated Urological Specialists
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Melvin and Bren Simon Cancer Center
  • Michigan
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Michigan Institute of Urology
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Specialty Clinical Research of St Louis
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • SUNY Upstate Med Univ
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Urology Specialists of the Carolinas PLLC Charlotte
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Recruiting
      • Low Country Urology Clinics
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Urology Specialists of South Dakota
  • Texas
    • Arlington, Texas, United States, 76017
      • Recruiting
      • UPNT Research Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington School of Medicine
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate	CR rate is defined as the percentage of participants achieving a CR at any time after the initial TAR-200 treatment. CR is defined as the total absence of NMIBC (both CIS and papillary) per investigator assessment.	At 3, 6, 12, 18, and 24 months
Duration of Response (DOR)	DOR is defined as the interval between the noted date of first complete response of any kind to TAR-200 and the date on which recurrence of NMIBC (Ta, any T1 or CIS), progressive disease or death due to NMIBC occurs, whichever occurs first.	Up to 24 months
Overall Survival (OS)	OS is defined as the interval between the date of the first TAR-200 administration and date of death due to any cause.	Up to 24 months
Cancer-Specific Survival (CSS)	CSS is defined as the interval between the date of the first TAR-200 insertion and date of death due to bladder cancer or if cause of death is unknown.	Up to 24 months
Time to Next Treatment (TTNT)	TTNT is defined as the time difference from the first TAR-200 insertion date to the start date of next bladder cancer treatment.	Up to 24 months
Number of Participants with Radical Cystectomy (RC) /Bladder-Intact Survival	Radical cystectomy or bladder-intact survival is defined as the time from first TAR-200 insertion date to the date of the first evidence of radical cystectomy.	Up to 24 months
Time to RC /Bladder-Intact Survival	Radical cystectomy or bladder-intact survival is defined as the time from first TAR-200 insertion date to the date of the first evidence of radical cystectomy.	Up to 24 months
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. AE related to TAR-200 treatment and/or TAR-200 procedure (that is, insertion and removal of TAR-200 or its urinary placement catheter [UPC]) will be reported.	Up to 24 months
Treatment Patterns for TAR-200	Treatment patterns, including frequency, adherence, sequencing, and reasons for initiation, interruption, and discontinuation of treatment, and subsequent line of treatment (including re-treatment with TAR-200) will be reported.	Up to 24 months
Time to TAR-200 Discontinuation	Time to TAR-200 discontinuation will be reported.	Up to 24 months
Study Dropout Rate	Study dropout rate and reason for dropout from the study will be reported.	Up to 24 months
Treatment Adherence: Impact of Follow-up Reminders	Number of participants who adhered to treatment after follow-up reminders will be reported.	Up to 24 months
DFS After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow Transurethral Resection of bladder tumor (TURBT) for papillary disease or cold cup biopsy for CIS only recurrence. 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 CIS), progression (to MIBC [T greater than or equal to {>=} 2] or to lymph node [N+] or to distant disease [M+], whichever occurs first), or death due to NMIBC, whichever occurs first.	Up to 24 months
CR Rate After Re-treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for carcinoma in-situ (CIS) only recurrence. CR rate is defined as the percentage of participants achieving a CR at any time after the TAR-200 re-treatment. CR is defined as the total absence of NMIBC (both carcinoma in-situ [CIS] and papillary) per investigator assessment.	Up to 24 months
DOR After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. DOR is defined as the interval between the noted date of first complete response of any kind to TAR-200 and the date on which recurrence of NMIBC (Ta, any T1 or CIS), progressive disease or death due to NMIBC occurs, whichever occurs first.	Up to 24 months
OS After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. OS is defined as the interval between the date of the first TAR-200 re-administration and date of death due to any cause.	Up to 24 months
CSS After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. CSS is defined as the interval between the date of the TAR-200 re-insertion and date of death due to bladder cancer or if cause of death is unknown.	Up to 24 months
TTNT After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. TTNT is defined as the time difference from TAR-200 re-insertion date to the start date of next bladder cancer treatment.	Up to 24 months
Number of Participants with Radical cystectomy/ Bladder-Intact Survival After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. Radical cystectomy or bladder-intact survival is defined as the time from TAR-200 re-insertion date to the date of the first evidence of radical cystectomy.	Up to 24 months
Time to RC /Bladder-Intact Survival After Re-Treatment with TAR-200	Re-treatment is defined as treating a participant with TAR-200 after NMIBC recurrence and may follow TURBT for papillary disease or cold cup biopsy for CIS only recurrence. Radical cystectomy or bladder-intact survival is defined as the time from TAR-200 re-insertion date to the date of the first evidence of radical cystectomy.	Up to 24 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): October 9, 2029

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: 17000139BLC4004 (Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No