Intermediate Risk Non-Muscle Invasive Bladder Cancer
Conditions
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)
Interventions
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free survival | 24 months | Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 24 months | Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24 |
| Recurrence Free Survival at 12 Months | 12 months | Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months |
| Recurrence Free Survival at 24 Months | 24 Months | Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months |
Countries
Canada, Czechia, Denmark, France, Japan, Poland, South Korea, Spain, United States
Contacts
CONTACTFerring Pharmaceuticals
STUDY_DIRECTORGlobal Clinical Compliance
Ferring Pharmaceutical
Outcome results
None listed