Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Erdafitinib for patients with localized bladder cancer. The main goal is to find out the best dose of this treatment and see how effective it is. The trial is divided into three parts: the first part will test different doses to find the right one, the second part will expand on this to gather more information, and the third part will confirm how safe and effective the treatment is at that dose.

To be eligible for this trial, participants should have specific types of bladder cancer, either muscle-invasive or recurrent non-muscle-invasive, and meet other criteria related to past treatments. For instance, some participants may need to have experienced certain other treatments or be willing to undergo surgery. Throughout the trial, participants will receive the treatment and be monitored for its effects, with the hope of improving the options available for bladder cancer treatment. This trial is currently recruiting participants of all genders, typically aged between 65 and 74.

Gender

ALL

Eligibility criteria

• 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
• • Known allergies, hypersensitivity, or intolerance to any study component or its excipients
• • Has a current diagnosis of primary 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