Non-Muscle Invasive Bladder NeoplasmsNCT06877676
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
A study testing TAR-200 in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Neoplasms
- What is being tested?
- TAR-200
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial
- Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC), carcinoma in situ (CIS) (OR Tis) with or without papillary disease (T1, high-grade Ta), within 12 months of completion of the last dose of BCG therapy, in participants who have received adequate Bacillus Calmette-Guérin (BCG)
- All visible papillary disease must be fully resected (absent) prior to initiation of treatment
- Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
Who cannot join
- Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
- Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
- Evidence of bladder perforation during diagnostic cystoscopy
- A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than HR-NMIBC
About this study
Official title: Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
- Conditions
- Non-Muscle Invasive Bladder Neoplasms
- Being tested
- TAR-200
- 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.
TAR-200Drug
Participants will undergo insertion of TAR-200 transurethrally into the bladder via catherization using the co-packed urinary placement catheter only in accordance with the Instructions for Use (IFU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
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
- Expanded access
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
- NCT06877676
- Sponsor's protocol ID
- 17000139BLC4003
- Other IDs
- 17000139BLC4003
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
- ClinicalTrials.gov ID
- NCT06877676
- Acronym / sponsor ID
- 17000139BLC4003
- Conditions
- Non-Muscle Invasive Bladder Neoplasms
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 14 Mar 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 pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial
- Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC), carcinoma in situ (CIS) (OR Tis) with or without papillary disease (T1, high-grade Ta), within 12 months of completion of the last dose of BCG therapy, in participants who have received adequate Bacillus Calmette-Guérin (BCG)
- All visible papillary disease must be fully resected (absent) prior to initiation of treatment
- Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
Key exclusion criteria (5 listed)
- Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
- Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
- Evidence of bladder perforation during diagnostic cystoscopy
- A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than HR-NMIBC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAR-200Participants will undergo insertion of TAR-200 transurethrally into the bladder via catherization using the co-packed urinary placement catheter only in accordance with the Instructions for Use (IFU). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
A study testing TAR-200 in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.