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.
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
23 sites in 1 country
United States23 sites, 23 recruiting
- 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
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).
- Conditions
- Non-Muscle Invasive Bladder Neoplasms
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
Time to TAR-200 Discontinuation
Time to TAR-200 discontinuation will be reported.
Measured: Up to 24 months
Study Dropout Rate
Study dropout rate and reason for dropout from the study will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted30 Dec 2025
- Study start12 Jun 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion28 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07309445
- Acronym / sponsor ID
- Nova-sTAR / 17000139BLC4004
- Conditions
- Non-Muscle Invasive Bladder Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 28 Jun 2030 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-Free Survival (DFS)
Time frame: Up to 24 months
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.
20 secondary outcomes
Complete Response (CR) Rate
Time frame: At 3, 6, 12, 18, and 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Cancer-Specific Survival (CSS)
Time frame: Up to 24 months
Time to Next Treatment (TTNT)
Time frame: Up to 24 months
Number of Participants with Radical Cystectomy (RC) /Bladder-Intact Survival
Time frame: Up to 24 months
Time to RC /Bladder-Intact Survival
Time frame: Up to 24 months
Number of Participants with Adverse Events (AEs)
Time frame: Up to 24 months
Treatment Patterns for TAR-200
Time frame: Up to 24 months
Time to TAR-200 Discontinuation
Time frame: Up to 24 months
Study Dropout Rate
Time frame: Up to 24 months
Treatment Adherence: Impact of Follow-up Reminders
Time frame: Up to 24 months
DFS After Re-Treatment with TAR-200
Time frame: Up to 24 months
CR Rate After Re-treatment with TAR-200
Time frame: Up to 24 months
DOR After Re-Treatment with TAR-200
Time frame: Up to 24 months
OS After Re-Treatment with TAR-200
Time frame: Up to 24 months
CSS After Re-Treatment with TAR-200
Time frame: Up to 24 months
TTNT After Re-Treatment with TAR-200
Time frame: Up to 24 months
Number of Participants with Radical cystectomy/ Bladder-Intact Survival After Re-Treatment with TAR-200
Time frame: Up to 24 months
Time to RC /Bladder-Intact Survival After Re-Treatment with TAR-200
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliza M. Raymundo, MD, DMCC, FPUA, FPCS contact
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
23 sites in 1 country: see every site and its status.
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.