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Brief Title: Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

INTRODUCTION

  • Org Study ID: 42756493BLC3004
  • Secondary ID: N/A
  • NCT ID: NCT06319820
  • Sponsor: Janssen Research & Development, LLC

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    January 15, 2024
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Disease Free Survival (DFS)

Primary Outcome 1 - Timeframe: From randomization to the date of the first documented recurrence

CONDITION

  • Non-Muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* 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)

- * 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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial

Role: Study Director

Affiliation: Johnson & Johnson Enterprise Innovation Inc.

Overall Contact

Name: Study Contact

Phone: 844-434-4210

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Arkansas Urology
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: N/A
Facility: Genesis Research LLC
Los Alamitos, California 90720
United States
Status: Recruiting Contact: N/A
Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: University of California Irvine Medical Center
Orange, California 92868
United States
Status: Recruiting Contact: N/A
Facility: Genesis Research
San Diego, California 92123
United States
Status: Recruiting Contact: N/A
Facility: Genesis Research LLC
Sherman Oaks, California 91411
United States
Status: Recruiting Contact: N/A
Facility: Colorado Clinical Research
Lakewood, Colorado 80228
United States
Status: Recruiting Contact: N/A
Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: N/A
Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: N/A
Facility: First Urology
Jeffersonville, Indiana 47130
United States
Status: Recruiting Contact: N/A
Facility: Wichita Urology Group
Wichita, Kansas 67226
United States
Status: Recruiting Contact: N/A
Facility: Ochsner Health System
New Orleans, Louisiana 70121-2429
United States
Status: Recruiting Contact: N/A
Facility: Chesapeake Urology Research Associates
Hanover, Maryland 21076
United States
Status: Recruiting Contact: N/A
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact: N/A
Facility: Comprehensive Urology
Royal Oak, Michigan 48073
United States
Status: Recruiting Contact: N/A
Facility: Mercy Research
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: N/A
Facility: Specialty Clinical Research of St Louis
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: N/A
Facility: The Urology Center, PC
Omaha, Nebraska 68114
United States
Status: Recruiting Contact: N/A
Facility: Cancer Institute Of New Jersey
New Brunswick, New Jersey 08901
United States
Status: Recruiting Contact: N/A
Facility: Integrated Medical Professionals
New York, New York 10016
United States
Status: Recruiting Contact: N/A
Facility: Associated Medical Professionals of Ny
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: SUNY Upstate Med Univ
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: N/A
Facility: Associated Urologists of North Carolina
Raleigh, North Carolina 27612
United States
Status: Recruiting Contact: N/A
Facility: MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United States
Status: Recruiting Contact: N/A
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: The Conrad Pearson Clinic
Germantown, Tennessee 38138
United States
Status: Recruiting Contact: N/A
Facility: University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
Status: Recruiting Contact: N/A
Facility: Urology Associates
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: N/A
Facility: Urology Austin
Austin, Texas 78745
United States
Status: Recruiting Contact: N/A
Facility: Urology Clinics of North Texas
Dallas, Texas 75231
United States
Status: Recruiting Contact: N/A
Facility: Houston Metro Urology
Houston, Texas 77027
United States
Status: Recruiting Contact: N/A
Facility: Spokane Urology
Spokane, Washington 99202
United States
Status: Recruiting Contact: N/A