Testing Nadofaragene Firadenovec for intermediate risk non-muscle invasive bladder cancer
Official title: Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
- Phase 3
- 2 groups
- Sites in Calgary, Burlington and 1 more city
- Recruiting
Interventions
- Medication
Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Prostate Cancer Centre
Calgary, Alberta
- Recruiting
G kenneth Jansz Medicine Professional Corporation
Burlington, Ontario
- Recruiting
University Health Network UHN - Princess Margaret Cancer Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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)
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- +Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →:
Exclusion
- −Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Nadofaragene Firadenovec.
Registry label: A: Arm 1 Nadofaragene Firadenovec
Group B receives no study treatment and is followed for comparison.
Registry label: B: Arm 2 - Observation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 454 people.
The study is currently expected to finish around June 2031.
The main measurement is taken over: 24 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recurrence Free survival — measured over 24 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06510374 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Nadofaragene FiradenovecDrug
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 24 months.
The study as a whole is currently expected to finish around 2031-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 454 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Calgary, Alberta, Canada; Burlington, Ontario, Canada; Toronto, Ontario, Canada; Rochester, Minnesota, United States; Albany, New York, United States; Cheektowaga, New York, United States, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Other Sites (10)
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, United States
Albany Medical College
Albany, New York, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
New York, New York, United States
Integrated Medical Professionals, PLLC
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
Spokane Urology PLLC
Spokane, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.