Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange 5379513, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Official Title

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

Keywords

Non-Muscle Invasive Bladder Neoplasms, Mitomycin, Gemcitabine, TAR-200, Mitomycin C

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine Medical Center in progress, not accepting new patients
    Orange 5379513 California 5332921 92868 United States
  • Genesis Research LLC completed
    Los Alamitos 5368304 California 5332921 90720 United States
  • Chungbuk National University Hospital accepting new patients
    Chungcheongbuk Do 28644 South Korea
  • Keimyung University Dongsan Hospital accepting new patients
    Daegu 1835329 42601 South Korea
  • National Cancer Center accepting new patients
    Gyeonggi-do 6363696 10408 South Korea
  • Chonnam National University Hwasun Hospital completed
    Jeollanam-do 58128 South Korea
  • Seoul National University Hospital accepting new patients
    Seoul 1835848 03080 South Korea
  • Samsung Medical Center accepting new patients
    Seoul 1835848 06351 South Korea
  • The Catholic University of Korea Seoul St Mary s Hospital completed
    Seoul 1835848 06591 South Korea
  • Pusan National University Yangsan Hospital accepting new patients
    Yangsan 1832828 50612 South Korea

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT06211764
Phase
Phase 3 Bladder Cancer Research Study
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated