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

NCT06510374

RecruitingPhase 3

Sponsor: Ferring Pharmaceuticals

Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer

Interventions: Nadofaragene Firadenovec

Countries: United States, Canada, Czechia, Denmark, France, Japan, Poland, South Korea

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 adequate 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

    * Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
    * Restage TURBT may be done at the discretion of the investigator

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-Guérin (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
Locations (106)
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Bakersfield, California, United States
  • Fresno, California, United States
  • Los Angeles, California, United States
  • Murrieta, California, United States
  • Orange, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Largo, Florida, United States
  • Sarasota, Florida, United States
  • Atlanta, Georgia, United States
  • Lisle, Illinois, United States
  • Quincy, Illinois, United States
  • Jeffersonville, Indiana, United States
  • Clive, Iowa, United States
  • Wichita, Kansas, United States
  • Lexington, Kentucky, United States
  • Annapolis, Maryland, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • Creve Coeur, Missouri, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Morristown, New Jersey, United States
  • + 76 more on CT.gov