17000139BLC3004: 17000139BLC3004 [SunRISe-5] Ph III HR NMIBC BCG Exp/UR Pap (N=250)

Study Identifier:
17000139BLC3004
CT.gov Identifier:
NCT06211764
EudraCT Identifier:
202350768510
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.

Main objectives:

To compare disease free survival in participants receiving TAR-200 versus MMC or gemcitabine with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1. year of last dose of bacillus calmette-guerin (BCG) therapy and who refused or are unfit for radical cystectomy (RC).

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.
Phase III
Sex
Female & Male
Age
18 - 120 Years
Study Drug
Drug: Experimental: Group A
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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