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Clinical Trials in the UK / NCT06919965
Recruiting Phase 3

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

NCT06919965 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-09-10
Last updated
2026-08-28

Condition(s) studied

Non-Muscle Invasive Bladder Neoplasms

Investigational drug(s) / intervention(s)

TAR-210Mitomycin CGemcitabine

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)

Trial sites (113)

FacilityCityRegionStatus
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

Other trials for the same condition

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.

View NCT06919965 on ClinicalTrials.gov ↗ ← All trials in the UK