Study Comparing TAR-210 and Chemotherapy for High-Risk Non-Muscle-Invasive Bladder Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT06919965

This clinical trial is comparing two treatments, TAR-210 and intravesical chemotherapy, to see which is more effective in preventing the return or progression of high-risk non-muscle-invasive bladder cancer.

Patient Parameters

Program Overview

The main goal of this study is to find out if TAR-210 or intravesical chemotherapy is better at keeping high-risk non-muscle-invasive bladder cancer from coming back or getting worse. Participants will receive either TAR-210 or a chemotherapy treatment chosen by their doctor, and researchers will track how long they remain free of cancer symptoms.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with specific tumor characteristics.
  • Have a specific genetic mutation or fusion in the FGFR gene, confirmed by urine or tumor tissue testing.
  • All visible tumors must be removed before starting the study, and urine tests must not show signs of high-grade cancer.
  • Must have received a certain amount of BCG treatment in the past, or have been unable to complete BCG treatment due to side effects.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must not be eligible for or must refuse bladder removal surgery (radical cystectomy).

Exclusion Criteria

  • Have had carcinoma in situ (CIS) or more advanced bladder cancer at any time.
  • Have other active cancers that are progressing or have required treatment changes in the last 24 months, except for certain low-risk cancers.
  • Have bladder or urethral conditions that could make it unsafe to use TAR-210.
  • Have a history of excessive urination, with more than 4,000 mL of urine in 24 hours.
  • Cannot have a permanent catheter, but occasional catheter use is allowed.

Locations

FACILITYZIPCITYSTATE
Colorado Clinical Research80228LakewoodColorado
Georgia Urology30328AtlantaGeorgia
Comprehensive Urology48073Royal OakMichigan
UroHealth Partners68114OmahaNebraska
Dayton Physicians Network Urology45459CentervilleOhio
Helios Clinical Research, LLC44130Middleburg HeightsOhio
Oregon Urology Institute97477SpringfieldOregon
MidLantic Urology19004Bala-CynwydPennsylvania
MidLantic Urology17604LancasterPennsylvania
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center15232PittsburghPennsylvania

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