A Phase III, 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

Study Identifier:
17000139BLC3004
CT.gov Identifier:
NCT06211764
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-507685-10-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Group A
    • Read More
  • Drug: Active Comparator: Group B
  • Drug: Drug: Gemcitabine
  • Drug: Experimental drug
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder