NCT06510374ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

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

Phase 3454 participants sought107 sites9 countries

Registered in 1 registry

ClinicalTrials.govNCT06510374Open this record at ClinicalTrials.govSynced 2 weeks ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

Interested in this study?

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-07-19; recorded start 2024-10-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 16 other studies in this databaseCounted from the lead sponsor named in the record (Ferring Pharmaceuticals)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 103 sites
Data monitoring committee0/7
Data monitoring committee not stated in the record
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 454 participants (target), run at 107 sites, across 9 countries.

How this score is built

Enrolment26/40
454 participants (target)
Site count23/25
103 sites
Country count12/15
9 countries
Planned duration10/10
Planned over about 82 months
Sponsor scale4/10
Ferring Pharmaceuticals has led 17 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	454 participants sought

Sponsor and collaborators

Ferring Pharmaceuticals Sponsor

Arms and interventions

Arm 1 Nadofaragene FiradenovecEXPERIMENTAL
Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits.
Arm 2 - ObservationNO_INTERVENTION
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. .

Interventions

Drug Nadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.

Outcome measures

Primary outcome
Recurrence Free survival
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.
Time frame 24 months
Secondary outcome
Adverse Events
Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24
Time frame up to 24 months
Secondary outcome
Recurrence Free Survival at 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
Time frame 12 months
Secondary outcome
Recurrence Free Survival at 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
Time frame 24 Months

Dates

Dates
Start date	October 1, 2024 (actual)
Primary completion	June 30, 2028 (estimated)
Completion	June 30, 2031 (estimated)
First posted	July 19, 2024 (actual)
Last updated	September 4, 2026
Results posted	Not stated in the registry record
Status last verified	May 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

105 sites are recruiting

Canada

Canada
Facility	City	State or region	Status
G kenneth Jansz Medicine Professional Corporation	Burlington	Ontario	Recruiting
Prostate Cancer Centre	Calgary	Alberta	Recruiting
University Health Network UHN - Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting

Czechia

Czechia
Facility	City	State or region	Status
Kromerizska Nemocnice A S	Kroměříž		Recruiting
Krajska Nemocnice Liberec	Liberec		Recruiting
Fakultní Thomayerova Nemocnice	Prague	Prague	Recruiting
Fakultní Thomayerova Nemocnice	Prague		Recruiting
Androgeos, spol. s r.o. Location	Prague	Prague	Recruiting

Denmark

Denmark
Facility	City	State or region	Status
Aarhus University Hospital	Aarhus		Recruiting

France

France
Facility	City	State or region	Status
CHU de Bordeaux - Hôpital Pellegrin	Bordeaux	New Aquitaine	Recruiting
CHU Clermont Ferrand - Hopital Gabriel Montpied	Clermont-Ferrand	Auvergne-Rhône-Alpes	Recruiting
Hospices Civils de Lyon - Edouard Herriot Hosp.	Lyon	Rhône-Alps	Recruiting
Centre Hospitaliser Universitaire de Lyon Sud	Lyon	Rhone-Alpe	Recruiting
CHU Nantes - Hotel Dieu	Nantes	Nantes	Recruiting
Centre Hospitalier Universitaire De Nimes (Nîmes)	Nîmes	Occitanie	Recruiting
Hopital La Pitie Salpetriere	Paris		Recruiting
APHP - Hopital Bichat	Paris	Île-de-France Region	Recruiting
CHU de Rouen - Hopital Charles-Nicolle	Rouen	Normandy	Recruiting
CHU Toulouse - Hopital Rangueil	Toulouse	Haute-Garonne	Recruiting

Japan

Japan
Facility	City	State or region	Status
Institute of Science Tokyo Hospital	Bunkyō-Ku	Tokyo	Recruiting
Kyushu University Hospital	Fukuoka	Fukuoka	Recruiting
Hiroshima University Hospital	Hiroshima	Hiroshima	Recruiting
Hitachi General Hospital	Hitachi	Ibaraki	Recruiting
Nara Medical University Hospital	Kashihara	Nara	Recruiting
St. Marianna University Hospital	Kawasaki	Kanagawa	Recruiting
Kobe University Hospital	Kobe	Hyōgo	Recruiting
National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime	Recruiting
Aichi Medical University Hospital	Nagakute	Aichi-ken	Recruiting
Nagoya University Hospital	Nagoya	Aichi-ken	Recruiting
Kochi Medical School Hospital	Nankoku	Kochi	Recruiting
Japanese Red Cross Narita Hospital	Narita	Chiba	Recruiting
Mie University Hospital	Tsu	Mie-ken	Recruiting
University of Tsukuba Hospital	Tsukuba	Ibaraki	Recruiting
Wakayama Medical University Hospital	Wakayama	Wakayama	Recruiting
Yokohama City University Hospital	Yokohama	Kanagawa	Recruiting

Poland

Poland
Facility	City	State or region	Status
IN-VIVO Bydgoszcz	Bydgoszcz	Kuyavian-Pomeranian Voivodeship	Recruiting
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.	Poznan	Wielkopolska	Recruiting
Medical Concierge Centrum Medyczne	Warsaw	Woj. Mazowieckie	Recruiting

South Korea

South Korea
Facility	City	State or region	Status
National Cancer Center	Goyang-si	Gyeonggi-do	Recruiting
Samsung Medical Center	Seoul	Seoul	Recruiting
Korea University Anam Hospital	Seoul	Seoul	Recruiting
Seoul National University Hospital	Seoul	Songpa-gu	Recruiting
Asan Medical Center	Seoul	Songpa-gu	Recruiting
Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do	Recruiting

Spain

Spain
Facility	City	State or region	Status
Hospital Universitario de A Coruna	A Coruña	Galicia	Recruiting
Hospital Universitario Fundacion Alcorcon	Alcorcón	Madrid	Recruiting
Hospital del Mar	Barcelona	Catalonia	Recruiting
Hospital Universitario Basurto	Bilbao	Vizcaya	Recruiting
Hospital Universitario Reina Sofia	Córdoba	Córdoba	Recruiting
Hospital Universitario Virgen De Las Nieves	Granada	Granada	Recruiting

57 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 4, 2026
Site added
1 site added (107 total)
106107
August 6, 2026
Site added
3 sites added (106 total)
103106

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06510374

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Canada

Czechia

Denmark

France

Japan

Poland

South Korea

Spain

Study documents

Changes over time