TAR-210: TAR-210 will be administered intravesically.
Gemcitabine: Gemcitabine will be administered intravesically.
MMC: MMC will be administered intravesically.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
* Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm
* 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
* 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 \> 4000 milliliters (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)
Substudy:
\- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis
Primary outcome measure(s)
Disease Free Survival (DFS) — From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months) DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
Trial sites (193)
Facility
City
Region
Status
Arkansas Urology
Little Rock
Arkansas
Completed
Genesis Research LLC
Los Alamitos
California
Active Not Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles
California
Active Not Recruiting
University of California Irvine Medical Center
Orange
California
Active Not Recruiting
Om Research LLC
San Diego
California
Active Not Recruiting
Genesis Research LLC 1
Sherman Oaks
California
Completed
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora
Colorado
Completed
Colorado Clinical Research
Lakewood
Colorado
Active Not Recruiting
Moffitt Cancer Center
Tampa
Florida
Active Not Recruiting
Northwestern University
Chicago
Illinois
Completed
First Urology
Jeffersonville
Indiana
Completed
Wichita Urology Group
Wichita
Kansas
Active Not Recruiting
Ochsner Health System
New Orleans
Louisiana
Active Not Recruiting
Chesapeake Urology Research Associates
Hanover
Maryland
Completed
Brigham And Women's Hospital
Boston
Massachusetts
Completed
Karmanos Cancer Institute
Detroit
Michigan
Active Not Recruiting
Comprehensive Urology
Royal Oak
Michigan
Active Not Recruiting
Mercy Research
St Louis
Missouri
Completed
Specialty Clinical Research of St Louis
St Louis
Missouri
Active Not Recruiting
The Urology Center, PC
Omaha
Nebraska
Active Not Recruiting
Cancer Institute Of New Jersey
New Brunswick
New Jersey
Active Not Recruiting
Integrated Medical Professionals
New York
New York
Completed
Memorial Sloan Kettering Cancer Center
New York
New York
Active Not Recruiting
Associated Medical Professionals of Ny
Syracuse
New York
Active Not Recruiting
SUNY Upstate Med Univ
Syracuse
New York
Active Not Recruiting
Levine Cancer Institute
Charlotte
North Carolina
Active Not Recruiting
Associated Urologists of North Carolina
Raleigh
North Carolina
Active Not Recruiting
MidLantic Urology
Bala-Cynwyd
Pennsylvania
Completed
Keystone Urology Specialists
Lancaster
Pennsylvania
Active Not Recruiting
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Active Not Recruiting
The Conrad Pearson Clinic
Germantown
Tennessee
Active Not Recruiting
University of Tennessee Medical Center
Knoxville
Tennessee
Completed
Urology Associates
Nashville
Tennessee
Active Not Recruiting
Urology Austin
Austin
Texas
Active Not Recruiting
Urology Clinics of North Texas
Dallas
Texas
Active Not Recruiting
UT Southwestern
Dallas
Texas
Completed
Houston Metro Urology
Houston
Texas
Active Not Recruiting
Spokane Urology
Spokane
Washington
Active Not Recruiting
Hospital Sirio Libanes
Buenos Aires
Argentina
Active Not Recruiting
Investigaciones Clinico Moleculares (ICM)
CABA
Argentina
Active Not Recruiting
+ 153 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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