A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Completed · Phase 2

Conditions studied: Urinary Bladder Neoplasms

In brief

The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.

Key facts

Study ID

NCT04172675

Run by

Janssen Research & Development, LLC

People needed

107

Starts

2020-02-28

Expected to finish

2025-02-27

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed
• Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions
• Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants
• Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only)
• Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1
• Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• A woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3)
• Adequate bone marrow, liver, and renal function as specified in the protocol

You may not qualify if…

• Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder
• Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder
• Prior treatment with an FGFR inhibitor
• Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy
• Current central serous retinopathy or retinal pigment epithelial detachment of any grade

Where it is running

• USC Institute of Urology — Los Angeles, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Urological Research Network — Hialeah, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Simmons Cancer Institute — Springfield, Illinois, United States
• University of Kansas — Westwood, Kansas, United States
• Albany Medical College — Albany, New York, United States
• NYU Langone Health — New York, New York, United States
• Great Lakes Physician PC d/b/a Western New York Urology Associates — Sanborn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• The Urology Group — Cincinnati, Ohio, United States
• The Ohio State University- James Cancer Hospital — Columbus, Ohio, United States
• Oregon Health And Science University — Portland, Oregon, United States
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
• University of Pittsburgh Medical Center - Cancer Centers — Pittsburgh, Pennsylvania, United States
• Urology Associates — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States
• Medical College of Wisconsin Froedtert Hospital — Milwaukee, Wisconsin, United States
• Sociedade Beneficente de Senhoras Hospital Sirio Libanes — Buenos Aires, Argentina
• CEMIC Saavedra — Buenos Aires, Argentina
• Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
• Urological Associates of Southern Arizona, P.C. — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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