RECRUITING

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-18

Study Completion:2028-06-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06319820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method) * 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	* 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 greater than (\>) 4000 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)

Inclusion Criteria

Exclusion Criteria

* 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. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method)
* 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

* 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 greater than (\>) 4000 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)

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study@its.jnj.com

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial

STUDY_DIRECTOR

Johnson & Johnson Enterprise Innovation Inc.

Study Locations (Sites)

Arkansas Urology

Little Rock, Arkansas, 72211

United States

Genesis Research LLC

Los Alamitos, California, 90720

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

University of California Irvine Medical Center

Orange, California, 92868

United States

Genesis Research

San Diego, California, 92123

United States

Genesis Research LLC

Sherman Oaks, California, 91411

United States

Colorado Clinical Research

Lakewood, Colorado, 80228

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Northwestern University

Chicago, Illinois, 60611

United States

First Urology

Jeffersonville, Indiana, 47130

United States

Wichita Urology Group

Wichita, Kansas, 67226

United States

Ochsner Health System

New Orleans, Louisiana, 70121-2429

United States

Chesapeake Urology Research Associates

Hanover, Maryland, 21076

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Comprehensive Urology

Royal Oak, Michigan, 48073

United States

Mercy Research

Saint Louis, Missouri, 63141

United States

Specialty Clinical Research of St Louis

Saint Louis, Missouri, 63141

United States

The Urology Center, PC

Omaha, Nebraska, 68114

United States

Cancer Institute Of New Jersey

New Brunswick, New Jersey, 08901

United States

Integrated Medical Professionals

New York, New York, 10016

United States

Associated Medical Professionals of Ny

Syracuse, New York, 13210

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

United States

Keystone Urology Specialists

Lancaster, Pennsylvania, 17604

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

The Conrad Pearson Clinic

Germantown, Tennessee, 38138

United States

University of Tennessee Medical Center

Knoxville, Tennessee, 37920

United States

Urology Associates

Nashville, Tennessee, 37209

United States

Urology Austin

Austin, Texas, 78745

United States

Urology Clinics of North Texas

Dallas, Texas, 75231

United States

Houston Metro Urology

Houston, Texas, 77027

United States

Spokane Urology

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, STUDY_DIRECTOR, Johnson & Johnson Enterprise Innovation Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2028-06-28

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2028-06-28

Terms related to this study

Additional Relevant MeSH Terms

Non-Muscle Invasive Bladder Cancer