RECRUITING

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Conditions

Non-Muscle Invasive Bladder Neoplasms Non-Muscle Invasive Bladder Cancer (NMIBC)Muscle Invasive Bladder Cancer (MIBC)

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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 the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).

Official Title

Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Quick Facts

Study Start:2022-04-11

Study Completion:2029-07-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05316155

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
* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder * For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests * Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible * Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC) * Cohorts 2 and 4: Willing and eligible for RC * Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors * Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size * Must submit tissue and urine for FGFR testing * Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment	* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium * Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor * Received pelvic radiotherapy \<=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (\>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis * Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system * Indwelling urinary catheter. Intermittent catheterization is acceptable * Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\>=5) years ago and there is documentation of low grade (LG) Ta thereafter * Known allergies, hypersensitivity, or intolerance to any study component or its excipients * Has a current diagnosis of newly diagnosed IR-NMIBC * Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study * Evidence of current bladder perforation by cystoscopy or imaging

Inclusion Criteria

Exclusion Criteria

* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
* For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests
* Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible
* Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
* Cohorts 2 and 4: Willing and eligible for RC
* Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors
* Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size
* Must submit tissue and urine for FGFR testing
* Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment

* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
* Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
* Received pelvic radiotherapy \<=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (\>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis
* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system
* Indwelling urinary catheter. Intermittent catheterization is acceptable
* Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\>=5) years ago and there is documentation of low grade (LG) Ta thereafter
* Known allergies, hypersensitivity, or intolerance to any study component or its excipients
* Has a current diagnosis of newly diagnosed IR-NMIBC
* Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study
* Evidence of current bladder perforation by cystoscopy or imaging

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study1@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

University of Alabama at Birmingham - The Kirklin Clinic

Birmingham, Alabama, 35294

United States

University of Southern California

Los Angeles, California, 90033

United States

Urology Associates of Denver

Lone Tree, Colorado, 80124

United States

Urological Research Network

Hialeah, Florida, 33016

United States

Advanced Urology Institute

Largo, Florida, 33771

United States

Advent Health Orlando

Orlando, Florida, 32804

United States

Advanced Urology Institute

Oxford, Florida, 34484

United States

H Lee Moffitt Cancer Center

Tampa, Florida, 33612

United States

Northwestern University

Chicago, Illinois, 60611

United States

Associated Urological Specialists

Chicago Ridge, Illinois, 60451

United States

Urology of Indiana

Greenwood, Indiana, 46143

United States

Urologic Specialists of Northwest Indiana

Merrillville, Indiana, 46410

United States

University of Kentucky

Lexington, Kentucky, 40506

United States

Southern Urology LLC

Lafayette, Louisiana, 70508

United States

Greater Boston Urology

Plymouth, Massachusetts, 02360

United States

Specialty Clinical Research of St Louis

St Louis, Missouri, 63141

United States

Hackensack University Medical Center Urology

Hackensack, New Jersey, 07601

United States

Associated Medical Professionals

Syracuse, New York, 13210

United States

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, 28204

United States

Central Ohio Urology Group

Gahanna, Ohio, 43230

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

Urology Austin

Austin, Texas, 78745

United States

Urology San Antonio Research

San Antonio, Texas, 78229

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 Date2022-04-11

Study Completion Date2029-07-24

Study Record Updates

Study Start Date2022-04-11

Study Completion Date2029-07-24

Terms related to this study

Keywords Provided by Researchers

Non-Muscle Invasive Bladder Cancer (NMIBC)
Muscle Invasive Bladder Cancer (MIBC)

Additional Relevant MeSH Terms

Non-Muscle Invasive Bladder Neoplasms