Recruiting
Phase 3

BCG vs. TAR-210

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06919965

Conditions

Non-Muscle Invasive Bladder Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAR-210

Mitomycin C

Gemcitabine

Study Details

Brief 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).

Conditions

Non-Muscle Invasive Bladder Neoplasms

Study ID

NCT06919965

Start date

Sep 10, 2025

Status verified date

Aug, 2026

Completion date

Mar 16, 2032

Anticipated

Primary completion date

Apr 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A: TAR-210

Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.

active comparator: Group B: Mitomycin C (MMC) or Gemcitabine

Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.

Interventions

TAR-210

TAR-210 will be administered intravesically.

Mitomycin C

MMC will be administered intravesically.

Gemcitabine

Gemcitabine will be administered intravesically.

Primary outcome measure

  • Disease-free Survival (DFS) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Academic Urology and Urogynecology of Arizona

Recruiting

Sun City, Arizona, United States, 85351

UCLA

Recruiting

Los Angeles, California, United States, 90095

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Advanced Urology Institute

Recruiting

Largo, Florida, United States, 33771

Georgia Urology

Recruiting

Atlanta, Georgia, United States, 30328

Associated Urological Specialists

Recruiting

Chicago Ridge, Illinois, United States, 60415

UroPartners

Recruiting

Glenview, Illinois, United States, 60026

Urology of Indiana

Recruiting

Carmel, Indiana, United States, 46032

Southern Urology LLC

Recruiting

Lafayette, Louisiana, United States, 70508

Greater Boston Urology

Recruiting

Plymouth, Massachusetts, United States, 02360

Comprehensive Urology

Recruiting

Royal Oak, Michigan, United States, 48073

New Jersey Urology LLC

Recruiting

Voorhees Township, New Jersey, United States, 08043

Associated Medical Professionals

Recruiting

Syracuse, New York, United States, 13210

Dayton Physicians Network Urology

Recruiting

Centerville, Ohio, United States, 45459

The Urology Group

Recruiting

Cincinnati, Ohio, United States, 45212

Oregon Urology Institute

Recruiting

Springfield, Oregon, United States, 97477

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Keystone Urology Specialists

Recruiting

Lancaster, Pennsylvania, United States, 17604

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

The Conrad Pearson Clinic

Recruiting

Germantown, Tennessee, United States, 38138

Texas Oncology-Austin

Recruiting

Austin, Texas, United States, 78731

Urology Austin

Recruiting

Austin, Texas, United States, 78745

Urology San Antonio PA dba USA Clinical Trials

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.