Home › Trials › NCT06211764

Comparing TAR-200 with Intravesical Chemotherapy for Bladder Cancer

A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Phase 3 Interventional Janssen Research & Development, LLC · NCT06211764

This study is testing if a new treatment called TAR-200 can help people with recurrent bladder cancer do better than the standard chemotherapy they would usually receive.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionschemotherapy
Locations123 sites (Little Rock, Arkansas and 122 other locations)
Trial IDNCT06211764 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of TAR-200 compared to standard intravesical chemotherapy in patients with recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are not candidates for radical cystectomy. Participants will be monitored for disease-free survival after receiving either TAR-200 or a single-agent chemotherapy of the investigator's choice. The study focuses on individuals who have experienced a recurrence of their cancer within one year of Bacillus Calmette-Guérin (BCG) therapy. The goal is to determine if TAR-200 can provide better outcomes than traditional treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with recurrent, papillary-only high-risk non-muscle-invasive bladder cancer who are ineligible for or have chosen not to have radical cystectomy.

Not a fit: Patients with carcinoma in situ or those with muscle-invasive or metastatic bladder cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with recurrent high-risk bladder cancer who cannot undergo surgery.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\]
* Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
* 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 of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
* 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
* A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
* Previous treatment with TAR-200

Where this trial is running

Little Rock, Arkansas and 122 other locations

+73 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Muscle Invasive Bladder Neoplasms
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.