Clinical trial NCT06510374: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Official title: A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 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

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

Primary outcomes:
measure: Recurrence Free survival
timeFrame: 24 months
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 24 months
measure: Recurrence Free Survival at 12 Months
timeFrame: 12 months
measure: Recurrence Free Survival at 24 Months
timeFrame: 24 Months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Ferring Investigational Site
state: Alabama
city: Fresno
country: United States
facility: Ferring Investigational Site
state: California
city: Los Angeles
country: United States
facility: Ferring Investigational Site
state: California
city: Murrieta
country: United States
facility: Ferring Investigational Site
state: California
city: Largo
country: United States
facility: Ferring Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Ferring Investigational Site
state: Georgia
city: Lexington
country: United States
facility: Ferring Investigational Site
state: Kentucky
city: Creve Coeur
country: United States
facility: Ferring Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Ferring Investigational Site
state: Nebraska
city: Albany
country: United States
facility: Ferring Investigational Site
state: New York
city: Bronx
country: United States
facility: Ferring Investigational Site
state: New York
city: Garden City
country: United States
facility: Ferring Investigational Site
state: New York
city: New York
country: United States
facility: Ferring Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Ferring Investigational Site
state: New York
city: Bala-Cynwyd
country: United States
facility: Ferring Investigational Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Ferring Investigational Site
state: South Carolina
city: Virginia Beach
country: United States
facility: Ferring Investigational Site
state: Virginia
city: Burlington
country: Canada
facility: Ferring Investigational Site
state: Ontario
city: Yokohama-shi
country: Japan
facility: Ferring Investigational Site
state: Kanagawa
city: Nankoku
country: Japan
facility: Ferring Investigational Site
state: Kochi
Study officials:
affiliation: Ferring Pharmaceutical
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: