TAR-210 vs Chemotherapy for Bladder Cancer

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Recruiting Phase 3 Interventional Study
Non-Muscle Invasive Bladder Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for

This trial is looking for people with high-risk non-muscle-invasive bladder cancer. Participants will receive either TAR-210 or standard chemotherapy to see which treatment helps them stay cancer-free longer.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with high-risk non-muscle-invasive bladder cancer.
  • I have a specific mutation tested from urine or tumor tissue.
  • My visible tumor has been completely removed before joining.
  • I have had enough treatment with BCG or couldn't finish it due to side effects.
  • My overall health is good (Grade 0, 1, or 2).
  • I cannot have or choose not to have radical cystectomy.

You may not be able to join if

  • I have had cancer in my bladder or a different type of cancer that is currently active.
  • I have a history of more serious bladder cancer.
  • I have any condition that may prevent safe treatment with TAR-210.
  • I have had very high urine output in the past.
  • I have an indwelling catheter.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-i…
Trial Locations
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Eligibility Criteria
Inclusion criteria: * Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded * H…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT