AzTrials
AzTrials

Non-Muscle Invasive Bladder NeoplasmsNova-sTARNCT07309445

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

An observational study of Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Muscle Invasive Bladder Neoplasms
How many people
150 participants
Where
23 sitesUnited States
Study dates
12 Jun 2026to 28 Jun 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

1-669-800-7705

23 sites in 1 country

United States23 sites, 23 recruiting
  • UPNT Research Institute

    Arlington, Texas, 76017

    Recruiting
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting
  • MidLantic Urology - Haverford Road - Bryn Mawr

    Bryn Mawr, Pennsylvania, 19010

    Recruiting
  • Urology Specialists of the Carolinas PLLC Charlotte

    Charlotte, North Carolina, 28204

    Recruiting
  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

    Recruiting
  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting
  • Frederick Health

    Frederick, Maryland, 21702

    Recruiting
  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting
  • Mayo Clinic

    Jacksonville, Florida, 32224

    Recruiting
  • Colorado Clinical Research

    Lakewood, Colorado, 80228

    Recruiting
  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Recruiting
  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting
  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting
  • Low Country Urology Clinics

    North Charleston, South Carolina, 29406

    Recruiting
  • Mayo Clinic 1

    Phoenix, Arizona, 85054

    Recruiting
  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Recruiting
  • University of Washington School of Medicine

    Seattle, Washington, 98195

    Recruiting
  • Urology Specialists of South Dakota

    Sioux Falls, South Dakota, 57108

    Recruiting
  • Spokane Urology

    Spokane, Washington, 99202

    Recruiting
  • Specialty Clinical Research of St Louis

    St Louis, Missouri, 63141

    Recruiting
  • SUNY Upstate Med Univ

    Syracuse, New York, 13210

    Recruiting
  • Michigan Institute of Urology

    Troy, Michigan, 48084

    Recruiting
  • Florida Urology Partners

    Wimauma, Florida, 33598

    Recruiting

Other trials in United States

About this study

Official title: 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).

Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07309445
Study groupRoleWhat they receive
NMIBC Participants: Routine Clinical Practice SettingParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months

Secondary outcomes (20)
  1. 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.

    Measured: At 3, 6, 12, 18, and 24 months

  2. 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.

    Measured: Up to 24 months

  3. 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.

    Measured: Up to 24 months

  4. 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.

    Measured: Up to 24 months

  5. 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.

    Measured: Up to 24 months

  6. 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.

    Measured: Up to 24 months

  7. 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.

    Measured: Up to 24 months

  8. 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.

    Measured: Up to 24 months

  9. 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.

    Measured: Up to 24 months

  10. Time to TAR-200 Discontinuation

    Time to TAR-200 discontinuation will be reported.

    Measured: Up to 24 months

  11. Study Dropout Rate

    Study dropout rate and reason for dropout from the study will be reported.

    Measured: Up to 24 months

  12. Treatment Adherence: Impact of Follow-up Reminders

    Number of participants who adhered to treatment after follow-up reminders will be reported.

    Measured: Up to 24 months

  13. 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.

    Measured: Up to 24 months

  14. 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.

    Measured: Up to 24 months

  15. 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.

    Measured: Up to 24 months

  16. 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.

    Measured: Up to 24 months

  17. 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.

    Measured: Up to 24 months

  18. 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.

    Measured: Up to 24 months

  19. 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.

    Measured: Up to 24 months

  20. 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start12 Jun 2026
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion28 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309445
Sponsor's protocol ID
17000139BLC4004
Acronym
Nova-sTAR
Status last verified
Nov 2026
First submitted
16 Dec 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in