TAR-210: TAR-210 will be administered intravesically.
Mitomycin C: MMC will be administered intravesically.
Gemcitabine: Gemcitabine will be administered intravesically.
Study summary
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
* 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
* All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
* Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
* Must be ineligible for or refusing radical cystectomy (RC)
Exclusion criteria:
* Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+)
* Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence
* Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
* A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Primary outcome measure(s)
Disease-free Survival (DFS) — Up to 5 years DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.
Trial sites (113)
Facility
City
Region
Status
Academic Urology and Urogynecology of Arizona
Sun City
Arizona
Recruiting
UCLA
Los Angeles
California
Recruiting
Colorado Clinical Research
Lakewood
Colorado
Recruiting
Advanced Urology Institute
Largo
Florida
Recruiting
Georgia Urology
Atlanta
Georgia
Recruiting
Associated Urological Specialists
Chicago Ridge
Illinois
Recruiting
UroPartners
Glenview
Illinois
Recruiting
Urology of Indiana
Carmel
Indiana
Recruiting
Southern Urology LLC
Lafayette
Louisiana
Recruiting
Greater Boston Urology
Plymouth
Massachusetts
Recruiting
Comprehensive Urology
Royal Oak
Michigan
Recruiting
UroHealth Partners
Omaha
Nebraska
Completed
New Jersey Urology LLC
Voorhees Township
New Jersey
Recruiting
Associated Medical Professionals
Syracuse
New York
Recruiting
Dayton Physicians Network Urology
Centerville
Ohio
Recruiting
The Urology Group
Cincinnati
Ohio
Recruiting
Helios Clinical Research, LLC
Middleburg Heights
Ohio
Completed
Oregon Urology Institute
Springfield
Oregon
Recruiting
MidLantic Urology
Bala-Cynwyd
Pennsylvania
Recruiting
Keystone Urology Specialists
Lancaster
Pennsylvania
Recruiting
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh
Pennsylvania
Recruiting
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Recruiting
The Conrad Pearson Clinic
Germantown
Tennessee
Recruiting
Texas Oncology-Austin
Austin
Texas
Recruiting
Urology Austin
Austin
Texas
Recruiting
Urology San Antonio PA dba USA Clinical Trials
San Antonio
Texas
Recruiting
Hospital Sirio Libanes
Buenos Aires
Argentina
Recruiting
Instituto Alexander Fleming
Buenos Aires
Argentina
Recruiting
Investigaciones Clinico Moleculares (ICM)
Caba
Argentina
Recruiting
Centro Urologico Profesor Bengio
Córdoba
Argentina
Recruiting
Sanatorio de la Mujer
Rosario
Argentina
Recruiting
Hopital Erasme
Brussels
Belgium
Recruiting
Ziekenhuis Oost-Limburg
Genk
Belgium
Recruiting
AZ Maria Middelares
Ghent
Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven
Belgium
Recruiting
Algemeen Ziekenhuis Delta
Roeselare
Belgium
Recruiting
Liga Norte Riograndense Contra O Cancer
Natal
Brazil
Recruiting
Hospital Regional do Cancer - Hospital de Esperanca
Presidente Prudente
Brazil
Recruiting
Funfarme Sjrp
São José do Rio Preto
Brazil
Recruiting
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo
Brazil
Recruiting
+ 73 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
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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