RECRUITING

Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

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Conditions

Intermediate Risk Non-Muscle Invasive Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Official Title

A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

Quick Facts

Study Start:2024-10-01
Study Completion:2031-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06510374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020)
  2. * Has undergone complete transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
  3. * Recurrence within 1 year, low-grade Ta
  4. * Solitary low-grade Ta \>3 cm
  5. * Low-grade Ta, multifocal
  6. * Solitary high-grade Ta, ≤3 cm
  7. * Low-grade T1
  8. * Restage TURBT may be done at the discretion of the investigator
  1. * Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
  2. * High-grade T1
  3. * Any recurrent, high-grade Ta
  4. * High-grade Ta \>3 cm (or multifocal)
  5. * Any carcinoma in situ (CIS)
  6. * Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
  7. * Any variant histology
  8. * Any prostatic urethral involvement
  9. * First occurrence of low-grade solitary Ta ≤3 cm
  10. * Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence
  11. * Papillary urothelial neoplasm of low malignant potential

Contacts and Locations

Study Contact

Global Clinical Compliance
CONTACT
+1 862-286-5200
Disclosure@ferring.com

Principal Investigator

Global Clinical Compliance
STUDY_DIRECTOR
Ferring Pharmaceutical

Study Locations (Sites)

Ferring Investigational Site
Los Angeles, California, 90017
United States
Ferring Investigational Site
Creve Coeur, Missouri, 63141
United States
Ferring Investigational Site
Omaha, Nebraska, 68114
United States
Ferring Investigational Site
Garden City, New York, 11530
United States
Ferring Investigational Site
Virginia Beach, Virginia, 23462
United States

Collaborators and Investigators

Sponsor: Ferring Pharmaceuticals

  • Global Clinical Compliance, STUDY_DIRECTOR, Ferring Pharmaceutical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2031-01-01

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2031-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer