A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
The primary objective of this study is to compare DFS between participants receiving TAR-210 versus investigator s choice of intravesical chemotherapy. The key secondary objectives of this study are to compare TTNT, HG RFS, PFS, rate of diagnostic and therapeutic urological interventions, safety, and tolerability between TAR-210 and investigator s choice of intravesical chemotherapy.
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
Inclusion Criteria
- Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion
either by urine testing or tumor tissue testing (from TURBT tissue), as determined
by central or local testing
- Participants must be willing to undergo all study procedures (e.g., multiple
cystoscopies from Screening through the end of study and TURBT for assessment of
recurrence/progression) and receive the assigned treatment, including intravesical
chemotherapy if randomized into that arm.
- Visible papillary disease must be fully resected prior to randomization and absence
of disease must be documented at Screening cystoscopy. The same method for
visualizing disease at Screening cystoscopy should be used throughout for the
participant (white light versus enhanced assessment method)
- Can have a prior or concurrent second malignancy (other than the disease under
study) which natural history or treatment is unlikely to interfere with any study
endpoints of safety or the efficacy of the study treatment
- Have an Eastern Cooperative Oncology Group performance status of 0 to 2
Exclusion Criteria
- Known allergies, hypersensitivity, or intolerance to any study component or its
excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system
constituent materials ; c. urinary placement catheter materials; d. MMC or
chemically related drugs; e. Gemcitabine or chemically related drugs
- Presence of any bladder or urethral anatomic feature (that is, urethral stricture)
that, in the opinion of the investigator, may prevent the safe insertion, indwelling
use, removal of TAR-210 or passage of a urethral catheter for intravesical
chemotherapy
- Polyuria with recorded 24-hour urine volumes greater than (>) 4000 mL
- Current indwelling urinary catheters, however, intermittent catheterization is
acceptable
- Had major surgery or had significant traumatic injury and/or not fully recovered
within 4 weeks before first dose (TURBT is not considered major surgery)
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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