Bladder Cancer Clinical Trial

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Summary

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

540

Study ID:

NCT06319820

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 10 Locations for this study

See Locations Near You

Arkansas Urology
Little Rock Arkansas, 72211, United States
Genesis Research LLC
Los Alamitos California, 90720, United States
Genesis Research LLC
Sherman Oaks California, 91411, United States
First Urology
Jeffersonville Indiana, 47130, United States
Associated Medical Professionals of Ny
Syracuse New York, 13210, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Keystone Urology Specialists
Lancaster Pennsylvania, 17604, United States
Urology Associates
Nashville Tennessee, 37209, United States
Urology Austin
Austin Texas, 78745, United States
Hadassah University Hospita - Ein Kerem
Jerusalem , 91120, Israel

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

540

Study ID:

NCT06319820

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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