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ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States (ABLE-41)

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ClinicalTrials.gov Identifier: NCT06026332
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : May 17, 2024
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date August 30, 2023
First Posted Date September 7, 2023
Last Update Posted Date May 17, 2024
Actual Study Start Date September 15, 2023
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2023)
  • 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 [ Time Frame: 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 [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 10, 2023)
  • Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR [ Time Frame: Up to 2 years ]
  • High-grade recurrence-free survival [ Time Frame: Up to 2 years ]
  • Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation [ Time Frame: 1 year ]
  • Incidence of and time to cystectomy [ Time Frame: Up to 2 years ]
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  • Overall Survival (OS) [ Time Frame: Up to 2 years ]
  • Mortality due to bladder cancer [ Time Frame: Up to 2 years ]
  • Prior treatments and outcomes before starting ADSTILADRIN treatment [ Time Frame: Before starting ADSTILADRIN treatment ]
  • Number of ADSTILADRIN instillations received and time intervals between instillations [ Time Frame: Up to 2 years ]
  • Reasons for discontinuation of ADSTILADRIN treatment [ Time Frame: End of trial (up to 2 years) ]
  • Concomitant therapies for bladder cancer and major comorbidities [ Time Frame: Up to 2 years ]
  • Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician [ Time Frame: 3 months ]
  • Subsequent line of therapy following ADSTILADRIN discontinuation [ Time Frame: Up to 2 years ]
  • Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter) [ Time Frame: 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) [ Time Frame: Up to 2 years ]
    WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.
  • 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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]
Original Secondary Outcome Measures
 (submitted: August 30, 2023)
  • Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR [ Time Frame: Up to 2 years ]
  • High-grade recurrence-free survival [ Time Frame: Up to 2 years ]
  • Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation [ Time Frame: 1 year ]
  • Incidence of and time to cystectomy [ Time Frame: Up to 2 years ]
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  • Overall Survival (OS) [ Time Frame: Up to 2 years ]
  • Mortality due to bladder cancer [ Time Frame: Up to 2 years ]
  • Prior treatments and outcomes before starting ADSTILADRIN treatment [ Time Frame: Before starting ADSTILADRIN treatment ]
  • Number of ADSTILADRIN instillations received and time intervals between instillations [ Time Frame: Up to 2 years ]
  • Reasons for discontinuation of ADSTILADRIN treatment [ Time Frame: End of trial (up to 2 years) ]
  • Concomitant therapies for bladder cancer and major comorbidities [ Time Frame: Up to 2 years ]
  • Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician [ Time Frame: 3 months ]
  • Subsequent line of therapy following ADSTILADRIN discontinuation [ Time Frame: Up to 2 years ]
  • Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States
Official Title ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.
Condition Bladder Cancer
Intervention Drug: ADSTILADRIN
Non-interventional
Other Name: Nadofaragene Firadenovec
Study Groups/Cohorts ADSTILADRIN
Intervention: Drug: ADSTILADRIN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 30, 2023)		 800
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Global Clinical Compliance 1-888-FERRING (1-888-337-7464) MedqueriesUS@ferring.com
Contact: Global Clinical Compliance +1 862-286-5200 (outside US) DK0-Disclosure@ferring.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT06026332
Other Study ID Numbers 000431
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Ferring Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor Ferring Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date May 2024