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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: ADSTILADRIN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADSTILADRIN<br> | Drug: ADSTILADRIN<br>* Non-interventional<br>* Other names: Nadofaragene Firadenovec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Subsequent line of therapy following ADSTILADRIN discontinuation |  | Up to 2 years | 
| Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter) |  | Before first ADSTILADRIN instillation and before each instillation thereafter | 
| 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 | 
| 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 | 
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, NMIBC, CIS, Ta/T1, BCG Unresponsive, Vesical instillation treatment