Erdafitinib Intravesical Delivery System: Erdafitinib intravesical delivery system will be administered.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Parts 1-3:
* 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
Part 4:
* 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
Exclusion Criteria:
Parts 1-3:
* 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
Part 4:
* 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
Primary outcome measure(s)
Parts 1 to 3: Number of Participants with Adverse Events (AEs) — Up to approximately 7 years 4 months An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Parts 1 to 3: Number of Participants with AEs by Severity — Up to approximately 7 years 4 months Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Part 1: Number of Participants with Dose-limiting Toxicity (DLT) — Up to 28 days Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC) — Up to approximately 7 years 4 months Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.
Trial sites (59)
Facility
City
Region
Status
University of Alabama at Birmingham - The Kirklin Clinic
Birmingham
Alabama
University of Southern California
Los Angeles
California
Urology Associates of Denver
Lone Tree
Colorado
Urological Research Network
Hialeah
Florida
Advanced Urology Institute
Largo
Florida
Advent Health Orlando
Orlando
Florida
Advanced Urology Institute 1
Oxford
Florida
H Lee Moffitt Cancer Center
Tampa
Florida
Northwestern University
Chicago
Illinois
Associated Urological Specialists
Chicago Ridge
Illinois
Urology of Indiana
Greenwood
Indiana
Urologic Specialists of Northwest Indiana
Merrillville
Indiana
University of Kentucky
Lexington
Kentucky
Southern Urology LLC
Lafayette
Louisiana
Greater Boston Urology
Plymouth
Massachusetts
Specialty Clinical Research of St Louis
St Louis
Missouri
Hackensack University Medical Center Urology
Hackensack
New Jersey
Associated Medical Professionals
Syracuse
New York
Levine Cancer Institute, Carolinas HealthCare System
Charlotte
North Carolina
Central Ohio Urology Group
Gahanna
Ohio
Carolina Urologic Research Center
Myrtle Beach
South Carolina
Low Country Urology Clinics
North Charleston
South Carolina
Urology Associates
Nashville
Tennessee
Urology Austin
Austin
Texas
Urology San Antonio Research
San Antonio
Texas
Vancouver Prostate Centre Diamond Health Care Centre
Vancouver
British Columbia
Nova Scotia Health Authority
Halifax
Nova Scotia
St Josephs Healthcare Hamilton
Hamilton
Ontario
Princess Margaret Cancer Centre
Toronto
Ontario
Universitatsklinikum Carl Gustav Carus Dresden
Dresden
Germany
Urologicum Duisburg
Duisburg
Germany
Universitatsklinikum Frankfurt
Frankfurt am Main
Germany
Marien hospital Herne
Herne
Germany
Urologie Neandertal Praxis Mettmann
Mettmann
Germany
Universitatsklinikum Munster
Münster
Germany
Universitaetsklinikum Ulm
Ulm
Germany
Rambam Medical Center
Haifa
Israel
Carmel Medical Center
Haifa
Israel
Rabin Medical Center
Petah Tikva
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
Israel
+ 19 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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