ACTIVE_NOT_RECRUITING

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

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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 purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Official Title

A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Quick Facts

Study Start:2024-04-09

Study Completion:2031-04-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06211764

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
* Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\] * Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded * Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC) * Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2	* 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, T2, T3, T4, N+, and/or M+) * 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-200. Participants with tumors involving the prostatic urethra in men will be excluded * A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL) * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable * Previous treatment with TAR-200

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\]
* Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
* Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

* 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, T2, T3, T4, N+, and/or M+)
* 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-200. Participants with tumors involving the prostatic urethra in men will be excluded
* A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
* Previous treatment with TAR-200

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

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

University of California San Francisco

San Francisco, California, 94158 2549

United States

Genesis Research LLC

Torrance, California, 90503

United States

Colorado Clinical Research

Lakewood, Colorado, 80228

United States

Florida Urology Partners

Riverview, Florida, 33578

United States

Northwestern University

Chicago, Illinois, 60611

United States

UroPartners

Chicago Ridge, Illinois, 60415

United States

Urology of Indiana

Carmel, Indiana, 46032

United States

First Urology, PSC

Jeffersonville, Indiana, 47130

United States

Wichita Urology Group

Wichita, Kansas, 67226

United States

Comprehensive Urology

Royal Oak, Michigan, 48073

United States

Specialty Clinical Research of St Louis

St Louis, Missouri, 63141

United States

Associated Medical Professionals

Syracuse, New York, 13210

United States

The Urology Group

Cincinnati, Ohio, 45212

United States

Central Ohio Urology Group

Gahanna, Ohio, 43230

United States

Centers for Advanced Urology LLC d b a MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

United States

Ralph H. Johnson Veterans Affairs Medical Center

Charleston, South Carolina, 29401

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

Low Country Urology Clinics

North Charleston, South Carolina, 29406

United States

Urology Associates

Nashville, Tennessee, 37209

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Urology Austin

Austin, Texas, 78745

United States

Urology Clinics of North Texas

Dallas, Texas, 75231

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

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

Janssen Research & Development, LLC Clinical trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

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 Date2024-04-09

Study Completion Date2031-04-14

Study Record Updates

Study Start Date2024-04-09

Study Completion Date2031-04-14

Terms related to this study

Additional Relevant MeSH Terms

Non-Muscle Invasive Bladder Neoplasms