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

NCT07309445 | Recruiting

• 1 other identifier: 17000139BLC4004
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Muscle Invasive Bladder Neoplasms

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

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Arkansas Urology

Little Rock, Arkansas, 72211, United States

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Eliza M. Raymundo, MD, DMCC, FPUA, FPCS

CONTACT

1-669-800-7705; Nova-sTAR_Sponsor@ubc.com

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: April 30, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)