Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

NCT ID: NCT06919965Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

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).

Arms & interventions

  • DrugTAR-210

    TAR-210 will be administered intravesically.

  • DrugMitomycin C

    MMC will be administered intravesically.

  • DrugGemcitabine

    Gemcitabine will be administered intravesically.

Outcome measures

Primary

  • Disease-free Survival (DFS)

    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.

    Time frame: Up to 5 years

Secondary

  • Recurrence-Free Survival (RFS)

    Time frame: Up to 5 years

  • Time to Next Intervention (TTNI)

    Time frame: Up to 5 years

  • Time to Disease Worsening (TTDW)

    Time frame: Up to 5 years

  • Time to Progression (TTP)

    Time frame: Up to 5 years

  • Overall Survival (OS)

    Time frame: Up to 5 years

  • Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Time frame: Up to 5 years

  • Number of Participants With Change from Baseline in Laboratory Abnormalities

    Time frame: Up to 5 years

  • Number of Participants With Change from Baseline in Vital Signs Abnormalities

    Time frame: Up to 5 years

  • Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  • Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  • Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores

    Time frame: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  • Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores

    Time frame: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  • Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168)

    Time frame: Up to Week 96

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (22)

Academic Urology and Urogynecology of Arizona

Sun City, Arizona, 85351

Recruiting

Colorado Clinical Research

Lakewood, Colorado, 80228

Recruiting

Georgia Urology

Atlanta, Georgia, 30328

Recruiting

Associated Urological Specialists

Chicago Ridge, Illinois, 60415

Recruiting

Urology of Indiana

Carmel, Indiana, 46032

Recruiting

Greater Boston Urology

Plymouth, Massachusetts, 02360

Recruiting

Comprehensive Urology

Royal Oak, Michigan, 48073

Recruiting

UroHealth Partners

Omaha, Nebraska, 68114

Completed

New Jersey Urology LLC

Voorhees Township, New Jersey, 08043

Recruiting

Associated Medical Professionals

Syracuse, New York, 13210

Recruiting

Dayton Physicians Network Urology

Centerville, Ohio, 45459

Recruiting

The Urology Group

Cincinnati, Ohio, 45212

Recruiting

Helios Clinical Research, LLC

Middleburg Heights, Ohio, 44130

Recruiting

Oregon Urology Institute

Springfield, Oregon, 97477

Recruiting

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

Recruiting

Keystone Urology Specialists

Lancaster, Pennsylvania, 17604

Recruiting

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Recruiting

The Conrad Pearson Clinic

Germantown, Tennessee, 38138

Recruiting

Texas Oncology-Austin

Austin, Texas, 78731

Recruiting

Urology Austin

Austin, Texas, 78745

Recruiting

Urology San Antonio PA dba USA Clinical Trials

San Antonio, Texas, 78229

Recruiting