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

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

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

Conditions2

Interventions1

Locations49 sites

Find trials near these locations

Related trials

• A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer — Ferring Pharmaceuticals
• A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC) — Memorial Sloan Kettering Cancer Center

Browse More Trials