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

Study Identifier:
423
CT.gov Identifier:
NCT06510374
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-512029-10-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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

To assess the efficacy and safety of ADSTILADRIN in intermediate-risk NMIBC (IR NMIBC), for which there are no U.S. FDA-approved treatment options.

To evaluate the efficacy of nadofaragene firadenovec administered every 3 months versus observation in participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

All participants will be evaluated for recurrence and progression using cytology, cystoscopy, and for-cause biopsy for up to 5 years

To evaluate the efficacy of intravesical instillation of FE 999326 versus observation in patients with intermediate-risk non-muscle invasive bladder cancer and to assess disease recurrence-free survival.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Arm 1 Nadofaragene Firadenovec
    • Read More
  • Drug: Subjects will receive quarterly doses of ADSTILADRIN or undergo continued observation following transurethral resection of bladder tumor (TURBT) within 60 days prior to randomization.
  • Drug: ASCO 2025:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * 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)
    • Has undergone complete transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
    • * Recurrence within 1 year, low-grade Ta
    • * Solitary low-grade Ta \>3 cm
    • *Low-grade Ta, multifocal
    • * Solitary high-grade Ta, ≤3 cm
    • * Low-grade T1
    • * Restage TURBT may be done at the discretion of the investigator
    • Adults diagnosed with new or recurrent intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and having undergone transurethral resection of bladder tumor within 60 days prior to randomization are eligible.
    • Included: Participants with newly diagnosed or recurrent intermediate-risk NMIBC at screening as defined by AIJA/SUO guideline
    • who had undergone TURBT within 60 days before randomization and have a life expectancy greater than 2 years
    Exclusion criteria
    • * Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
    • High risk NMIBC defined as:
    • * High-grade T1
    • * Any recurrent, high-grade Ta
    • * High-grade Ta >3 cm (or multifocal)
    • * Any carcinoma in situ (CIS)
    • * Any Bacillus Calmette-Guerin (BCG) failure in high-grade subject
    • * Any variant histology
    • * Any prostatic urethral involvement
    • Low risk NMIBC defined as:
    • * First occurrence of low-grade solitary Ta ≤3 cm
    • * Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
    • * Papillary urothelial neoplasm of low malignant potential
    • - Excluded: Participants with current or previous evidence Of muscle-invasive or metastatic disease at the screening visit or with low- or
    • high-riSk NMIBC

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Bladder