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Search / Trial NCT06877676

Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Mar 10, 2025

Trial Information

Current as of April 30, 2025

Available

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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

About Janssen Research & Development, Llc

Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

Patients applied

0 patients applied

Trial Officials

Janssen Research & Development, LLC Clinical Trial

Study Director

Janssen Research & Development, LLC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported