ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States

Bladder Cancer Clinical Trial

— ABLE-41  

Official title:

ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026332
• Other study ID #: 000431
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Ferring Pharmaceuticals
• Contact: Global Clinical Compliance
• Phone: 1-888-FERRING (1-888-337-7464)
• Email: MedqueriesUS[@]ferring.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multi-center, prospective non-interventional study to collect data on the early use of ADSTILADRIN in the US. Data will be collected from participants, caregivers and prescribing physicians in a real-world setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or received the first instillation of ADSTILADRIN per physician discretion after 5 September 2023 but prior to site activation
• Signed and dated ICF.
• Age 18 years or older at day ICF is signed.

Exclusion Criteria:

• Currently enrolled in a clinical trial.
• Participants who have previously been treated with ADSTILADRIN in the context of a clinical trial
• Participant is pregnant or breastfeeding.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• ADSTILADRIN
Non-interventional

Locations

Country	Name	City	State
United States	Ferring Investigational Site	Atlanta	Georgia
United States	Ferring Investigational Site	Baltimore	Maryland
United States	Ferring Investigational Site	Bronx	New York
United States	Ferring Investigational Site	Charlottesville	Virginia
United States	Ferring Investigation Site	Dallas	Texas
United States	Ferring Investigational Site	Gahanna	Ohio
United States	Ferring Investigational Site	Gainesville	Florida
United States	Ferring Investigational Site	Gilbert	Arizona
United States	Ferring Investigational Site	Greenwood	Indiana
United States	Ferring Investigational Site	Jeffersonville	Indiana
United States	Ferring Investigational Site	Little Rock	Arkansas
United States	Ferring Investigational Site	Los Angeles	California
United States	Ferring Investigational Site	Myrtle Beach	South Carolina
United States	Ferring Investigational Site	Nashville	Tennessee
United States	Ferring Investigational Site	New York	New York
United States	Ferring Investigational Site	Omaha	Nebraska
United States	Ferring Investigational Site	Rochester	Minnesota
United States	Ferring Investigational Site	Syracuse	New York
United States	Ferring Investigational Site	Virginia Beach	Virginia
United States	Ferring Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves Complete Response (CR) at first evaluation from first ADSTILADRIN instillation		3 months
Primary	Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation		1 year
Secondary	Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR		Up to 2 years
Secondary	High-grade recurrence-free survival		Up to 2 years
Secondary	Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation		1 year
Secondary	Incidence of and time to cystectomy		Up to 2 years
Secondary	Progression-free survival (PFS)		Up to 2 years
Secondary	Overall Survival (OS)		Up to 2 years
Secondary	Mortality due to bladder cancer		Up to 2 years
Secondary	Prior treatments and outcomes before starting ADSTILADRIN treatment		Before starting ADSTILADRIN treatment
Secondary	Number of ADSTILADRIN instillations received and time intervals between instillations		Up to 2 years
Secondary	Reasons for discontinuation of ADSTILADRIN treatment		End of trial (up to 2 years)
Secondary	Concomitant therapies for bladder cancer and major comorbidities		Up to 2 years
Secondary	Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician		3 months
Secondary	Subsequent line of therapy following ADSTILADRIN discontinuation		Up to 2 years
Secondary	Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter)		Before first ADSTILADRIN instillation and before each instillation thereafter
Secondary	Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)	WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.	Up to 2 years
Secondary	Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)	Domains captured will include product considerations and treatment satisfaction	Up to 2 years
Secondary	Type, incidence, relatedness to ADSTILADRIN, severity grading (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and seriousness of adverse events collected		End of trial (up to 2 years)
Secondary	Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results	Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests]	End of trial (up to 2 years)