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

Conditions

Intermediate Risk Non-Muscle Invasive Bladder Cancer

Talk to us

Study Overview

On this page

Study Details

Study overview

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

A Phase 3b, Randomized, Controlled 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

Condition
Intermediate Risk Non-Muscle Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Ferring Investigational Site, Los Angeles, California, United States, 90017

Creve Coeur

Ferring Investigational Site, Creve Coeur, Missouri, United States, 63141

Omaha

Ferring Investigational Site, Omaha, Nebraska, United States, 68114

Garden City

Ferring Investigational Site, Garden City, New York, United States, 11530

Virginia Beach

Ferring Investigational Site, Virginia Beach, Virginia, United States, 23462

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ferring Pharmaceuticals,

Global Clinical Compliance, STUDY_DIRECTOR, Ferring Pharmaceutical

Study Record Dates

2031-01-01