Study Comparing TAR-210 with Standard Bladder Cancer Treatment
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT06319820
This clinical trial is comparing the effectiveness of a new treatment, TAR-210, with standard intravesical chemotherapy in patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC). The main goal is to see which treatment helps patients stay disease-free longer.
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Program Overview
The purpose of this study is to find out if the new treatment, TAR-210, is better at keeping bladder cancer from returning compared to the usual chemotherapy treatment that is given directly into the bladder. This study focuses on patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Eligibility Criteria
Inclusion Criteria
- Have a specific genetic change in the fibroblast growth factor receptor (FGFR) found through urine or tumor tissue testing.
- Be willing to participate in all study procedures, including multiple bladder examinations and treatments.
- Have no visible bladder tumors before starting the study, confirmed by a bladder examination.
- Can have another type of cancer, as long as it doesn't affect the study's safety or effectiveness.
- Have a performance status score of 0 to 2, meaning fully active or with some limitations but able to care for oneself.
Exclusion Criteria
- Have known allergies or intolerances to any part of the study treatment, including specific drugs and materials used in the study.
- Have bladder or urethral conditions that might make it unsafe to use the study treatment or insert a catheter.
- Produce more than 4000 mL of urine in 24 hours.
- Have a permanent urinary catheter, although occasional catheter use is allowed.
- Have had major surgery or a significant injury and not fully recovered within 4 weeks before starting the study treatment.
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