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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 3, 2024
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment
Bladder Cancer Drug: ADSTILADRIN

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ADSTILADRIN Drug: ADSTILADRIN
Non-interventional
Other Name: Nadofaragene Firadenovec


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. High-grade recurrence-free survival [ Time Frame: Up to 2 years ]
  3. Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation [ Time Frame: 1 year ]
  4. Incidence of and time to cystectomy [ Time Frame: Up to 2 years ]
  5. Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  6. Overall Survival (OS) [ Time Frame: Up to 2 years ]
  7. Mortality due to bladder cancer [ Time Frame: Up to 2 years ]
  8. Prior treatments and outcomes before starting ADSTILADRIN treatment [ Time Frame: Before starting ADSTILADRIN treatment ]
  9. Number of ADSTILADRIN instillations received and time intervals between instillations [ Time Frame: Up to 2 years ]
  10. Reasons for discontinuation of ADSTILADRIN treatment [ Time Frame: End of trial (up to 2 years) ]
  11. Concomitant therapies for bladder cancer and major comorbidities [ Time Frame: Up to 2 years ]
  12. Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician [ Time Frame: 3 months ]
  13. Subsequent line of therapy following ADSTILADRIN discontinuation [ Time Frame: Up to 2 years ]
  14. Customized patient experience survey (before first ADSTILADRIN instillation and before each instillation thereafter) [ Time Frame: Before first ADSTILADRIN instillation and before each instillation thereafter ]
  15. 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.

  16. 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

  17. 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) ]
  18. 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]


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06026332


Contacts
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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

Locations
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United States, Arizona
Ferring Investigational Site Recruiting
Gilbert, Arizona, United States, 85234
Contact: Global Clinical Compliance         
United States, Arkansas
Ferring Investigational Site Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Ferring Investigational Site Recruiting
Los Angeles, California, United States, 90033
United States, Florida
Ferring Investigational Site Recruiting
Gainesville, Florida, United States, 32608
United States, Georgia
Ferring Investigational Site Recruiting
Atlanta, Georgia, United States, 30328
Contact: Global Clinical Compliance         
United States, Indiana
Ferring Investigational Site Recruiting
Greenwood, Indiana, United States, 46143
Contact: Global Clinical Compliance         
Ferring Investigational Site Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Kansas
Ferring Investigational Site Recruiting
Wichita, Kansas, United States, 67226
United States, Minnesota
Ferring Investigational Site Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Ferring Investigational Site Recruiting
Syracuse, New York, United States, 13210
United States, Ohio
Ferring Investigational Site Recruiting
Gahanna, Ohio, United States, 43230
Contact: Global Clinical Compliance         
United States, South Carolina
Ferring Investigational Site Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Global Clinical Compliance         
United States, Tennessee
Ferring Investigational Site Recruiting
Nashville, Tennessee, United States, 37209
United States, Virginia
Ferring Investigational Site Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Global Clinical Compliance         
Ferring Investigational Site Recruiting
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Global Clinical Compliance Ferring Pharmaceuticals
More Information
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT06026332    
Other Study ID Numbers: 000431
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferring Pharmaceuticals:
Bladder cancer
NMIBC
CIS
 Ta/T1
BCG Unresponsive
Vesical instillation treatment
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases