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New bladder cancer device offered to patients with no other options

NCT ID NCT06877676

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved This study
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This program gives patients with high-risk non-muscle invasive bladder cancer access to TAR-200 before it is officially approved. TAR-200 is a device placed into the bladder that releases medication over time. It is for patients who have tried all other treatments and cannot join a clinical trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAR-200 (a drug-releasing device inserted into the bladder via a catheter)
What this could lead to
If successful, this could provide a new treatment option for patients with high-risk bladder cancer who have run out of standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so results are not systematically collected. The treatment may not work for everyone and could have side effects like discomfort or infection from the device insertion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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 Exclusion criteria: * 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

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder neoplasms

More trials for these conditions

Other studies related to the condition(s) this trial covers.