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

Recruiting

• Conditions: Bladder Cancer
• Interventions: Drug: ADSTILADRIN

• Registration Number: NCT06026332
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-09-07
• Study Start: 2023-09-15
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADSTILADRIN	ADSTILADRIN	-

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
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
High-grade recurrence-free survival	Up to 2 years
Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation	1 year
Incidence of and time to cystectomy	Up to 2 years
Progression-free survival (PFS)	Up to 2 years
Overall Survival (OS)	Up to 2 years
Mortality due to bladder cancer	Up to 2 years
Prior treatments and outcomes before starting ADSTILADRIN treatment	Before starting ADSTILADRIN treatment
Number of ADSTILADRIN instillations received and time intervals between instillations	Up to 2 years
Reasons for discontinuation of ADSTILADRIN treatment	End of trial (up to 2 years)
Concomitant therapies for bladder cancer and major comorbidities	Up to 2 years
Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician	3 months
Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)	Up to 2 years	WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.
Subsequent line of therapy following ADSTILADRIN discontinuation	Up to 2 years
Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)	Before first ADSTILADRIN instillation and before each instillation thereafter
Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)	Before first ADSTILADRIN instillation
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)	Up to 2 years	Domains captured will include product considerations and treatment satisfaction
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)
Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results	End of trial (up to 2 years)	Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests\]

Trial Locations

Locations (2)

Ferring Investigational Site; 🇺🇸 Virginia Beach, Virginia, United States

Ferring Investigation Site; 🇺🇸 Dallas, Texas, United States