Recruiting NCT06510374
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nadofaragene Firadenovec.
- Who it may be relevant to
- Registry conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Czechia, Denmark, France +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Overview
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Interventions
- Drug Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Primary outcome measures
- Recurrence Free survival [Time frame: 24 months]
Secondary outcome measures (3)
- Adverse Events [Time frame: up to 24 months]
- Recurrence Free Survival at 12 Months [Time frame: 12 months]
- Recurrence Free Survival at 24 Months [Time frame: 24 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 52 centers
- University of South Alabama (USA) Health System - USACM — Mobile
- Urology Associates of Mobile — Mobile
- Mayo Clinic Arizona — Phoenix
- Center for Neurosciences — Tucson
- Arkansas Urology, North Little Rock — Little Rock
- Michael G Oefelein, MD Clinical Trials — Bakersfield
- Urology Associates of Central California — Fresno
- American Institute of Research — Los Angeles
- … and 44 more centers
Japan · 15 centers
- Aichi Medical University Hospital — Nagakute
- Nagoya University Hospital — Nagoya
- Japanese Red Cross Narita Hospital — Narita
- National Hospital Organization Shikoku Cancer Center — Matsuyama
- Kyushu University Hospital — Fukuoka
- Hiroshima University Hospital — Hiroshima
- Hitachi General Hospital — Hitachi
- University of Tsukuba Hospital — Tsukuba
- … and 7 more centers
Spain · 11 centers
Center list to be confirmed — check the primary protocol.
France · 10 centers
- CHU Clermont Ferrand - Hopital Gabriel Montpied — Clermont-Ferrand
- CHU Toulouse - Hopital Rangueil — Toulouse
- CHU Nantes - Hotel Dieu — Nantes
- CHU de Bordeaux - Hôpital Pellegrin — Bordeaux
- CHU de Rouen - Hopital Charles-Nicolle — Rouen
- Centre Hospitalier Universitaire De Nimes (Nîmes) — Nîmes
- Centre Hospitaliser Universitaire de Lyon Sud — Lyon
- Hospices Civils de Lyon - Edouard Herriot Hosp. — Lyon
- … and 2 more centers
South Korea · 6 centers
Center list to be confirmed — check the primary protocol.
Czechia · 5 centers
- Fakultní Thomayerova Nemocnice — Prague
- Androgeos, spol. s r.o. Location — Prague
- Kromerizska Nemocnice A S — Kroměříž
- Krajska Nemocnice Liberec — Liberec
- Fakultní Thomayerova Nemocnice — Prague
Canada · 3 centers
- Prostate Cancer Centre — Calgary
- G kenneth Jansz Medicine Professional Corporation — Burlington
- University Health Network UHN - Princess Margaret Cancer Centre — Toronto
Poland · 3 centers
Center list to be confirmed — check the primary protocol.
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT06510374 · 000423 · U1111-1284-0685