NCT06545955ClinicalTrials.gov

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

A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

RecruitingTaking participants now, according to the registry record.

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In brief

Phase 3250 participants sought76 sites7 countries

Registered in 1 registry

ClinicalTrials.govNCT06545955Open this record at ClinicalTrials.govSynced last month

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

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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 2024-08-09; 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 type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 76 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: 250 participants (target), run at 76 sites, across 7 countries.

How this score is built

Enrolment23/40
250 participants (target)
Site count22/25
76 sites
Country count12/15
7 countries
Planned duration10/10
Planned over about 76 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

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Conditions

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Eligibility

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

Eligibility as written in the registry

Inclusion Criteria: * Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease. * For T1 disease biopsies should contain muscle fibres. * Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to participants with high-grade non-muscle invasive bladder cancer (NMIBC) who are unlikely to benefit from and who will not be receiving further intravesical BCG. The term "BCG-Unresponsive" includes participants who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. The following criteria define the participants who may be included in the trial: * Have received at least 2 courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 of 3 instillations of maintenance BCG, or at least 2 of 6 instillations of a second induction course, where maintenance BCG is not given. o Exception: those who have T1 high-grade disease at 1st evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression * At the time of tumour recurrence, participants with CIS alone or high-grade Ta/T1 with CIS should be within 12 months of last exposure to BCG * No maximum limit to the amount of BCG administered * All visible papillary tumours must be resected and those with persistent T1 disease on transurethral resection of bladder tumour (TURBT) should undergo an additional re-TURBT within 14 to 70 days prior to beginning trial treatment. Obvious areas of CIS should also be fulgurated * Eastern Cooperative Oncology Group (ECOG) status ≤2 * Aged ≥18 years at the time of consent * Available for the whole duration of the trial * Life expectancy \>2 years, in the opinion of the investigator * Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumour by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or magnetic resonance imaging (MRI) with or without urogram performed within 6 months of enrolment. Absence of locally advanced disease as assessed by CT scan or MRI * Participants who elect not to undergo cystectomy * Participants with prostate cancer on active surveillance at low risk for progression are permitted to be included into the trial at the discretion of the investigator * Females of reproductive potential must have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraception during treatment with the investigational medicinal product and for 6 months following the last dose. Otherwise, female participants must be post-menopausal (no menstrual period for a minimum of 12 months, as confirmed by follicle-stimulating hormone levels) or surgically sterile * Male subjects must be willing to use a male condom and effective contraception during sex throughout the treatment period and for 3 months following the last dose. Exclusion Criteria: * Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive disease include but are not limited to: * Presence of lymphovascular invasion and / or micropapillary, sarcomatoid, plasmacytoid and / or neuroendocrine disease as shown in the histology of the biopsy sample * Participants with CIS+T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumour * Current systemic therapy for bladder cancer other than investigational medicinal products used in randomisation arm * Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non interventional study does not apply) within 1 month prior to screening * Current or prior pelvic external beam radiotherapy within 2 years of screening * Prior treatment with nadofaragene firadenovec at any time * Prior systemic therapy for bladder cancer at any time * Prior intravesical chemotherapy for the treatment of BCG-unresponsive NMIBC

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	250 participants sought

Sponsor and collaborators

Ferring Pharmaceuticals Sponsor

Arms and interventions

Nadofaragene firadenovecEXPERIMENTAL
Nadofaragene firadenovec (intravesical)
Nadofaragene firadenovec + gemcitabine & docetaxelEXPERIMENTAL
Nadofaragene firadenovec (intravesical), and sequential gemcitabine and docetaxel (intravesical)
Nadofaragene firadenovec + PembrolizumabEXPERIMENTAL
Nadofaragene firadenovec (intravesical), and pembrolizumab (IV infusion). This arm will be closed and patients will no longer be randomised to this arm. This modification will convert ABLE-22 into a two-arm study with 1:1 randomisation between nadofaragene alone and nadofaragene + gemcitabine/docetaxel, to now N=100 in each of the 2 remaining arms. Participants already enrolled in this arm will not be impacted.

Interventions

Drug Docetaxel
Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
Drug Gemcitabine
Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
Drug Nadofaragene Firadenovec
vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Drug Pembrolizumab
Pembrolizumab is an FDA approved immune checkpoint inhibitor which restores the anti-tumour immune response by blocking the programmed cell death protein 1 (PD-1). Pembrolizumab is administered via intravenous (IV) infusion.

Outcome measures

Primary outcome
Complete response
Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence).
Time frame up to 6 months
Secondary outcome
Complete response at month 6
Complete response 6 months from first treatment
Time frame 6 months
Secondary outcome
Complete response at month 3
Complete response 3 months from first treatment
Time frame 3 months
Secondary outcome
Durability of complete response
Durability of complete response (defined as time from achieved CR to HG recurrence, progression or death due to any cause).
Time frame Up to 24 months
Secondary outcome
Muscle-invasive progression of disease
Muscle-invasive progression of disease (defined as time from first treatment to first evidence of muscle-invasive disease or death)
Time frame up to 36 months
Secondary outcome
Cystectomy-free survival
Cystectomy-free survival (defined as time from first treatment to either cystectomy or death due to any cause)
Time frame up to 36 months
Secondary outcome
Pathological staging
Pathological staging (tumor, node, metastasis staging system) in participants at time of cystectomy
Time frame up to 36 months
Secondary outcome
Overall survival
Overall survival (defined as time from first treatment to death due to any cause)
Time frame up to 36 months
Secondary outcome
Evidence of malignant lesions of the upper tract and/or prostatic urethra
Evidence of malignant lesions of the upper tract and/or prostatic urethra (defined as time from first treatment to first evidence of malignant lesions).
Time frame up to 24 months
Secondary outcome
Adverse events
Adverse events collected for nadofaragene firadenovec in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab)
Time frame up to 36 months

Dates

Dates
Start date	October 1, 2024 (actual)
Primary completion	June 30, 2028 (estimated)
Completion	December 31, 2030 (estimated)
First posted	August 9, 2024 (actual)
Last updated	August 6, 2026
Results posted	Not stated in the registry record
Status last verified	November 2025

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

Locations

76 sites are recruiting

Canada

Canada
Facility	City	State or region	Status
Prostate Cancer Centre	Calgary	Alberta	Recruiting
Centre Hospitalier de L'Universite de Montreal	Montreal	Quebec	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	Zlín	Recruiting
Krajska Nemocnice Liberec	Liberec	Liberec Region	Recruiting
Fakultní Thomayerova Nemocnice	Prague	Prague	Recruiting
Fakultni nemocnice v Motole	Prague	Prague	Recruiting
Androgeos, spol. s r.o.	Prague	Prague	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
Centre Hospitaliser Universitaire de Lyon Sud	Lyon	Rhone.Alpe	Recruiting
Hospices Civils de Lyon - Edouard Herriot Hosp.	Lyon	Auvergne-Rhône-Alpes	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 Toulouse - Hopital Rangueil	Toulouse	Huate-Garonne	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
Seoul National University Hospital	Seoul	Songpa-gu	Recruiting
Samsung Medical Center	Seoul	Seoul	Recruiting
Korea University Anam Hospital	Seoul	Seoul	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 Clinic De Barcelona - University of Barcelona	Barcelona	Catalonia	Recruiting
Hospital Universitario Basurto	Bilbao	Vizcaya	Recruiting
Hospital Universitario Reina Sofia	Córdoba	Cordoba	Recruiting
Clinica Universidad de Navarra - Madrid	Madrid	Madrid	Recruiting
MD Anderson Cancer Center	Madrid		Recruiting
Hospital Universitario 12 De Octubre (Madrid)	Madrid	Madrid	Recruiting
Universidad Autonoma de Madrid. Hospital Universitario La Paz	Madrid	Madrid	Recruiting
Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)	Málaga		Recruiting
Clinica Universidad de Navarra - Pamplona	Pamplona	Navarre	Recruiting
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla	Santander	Cantabria	Recruiting

United States

United States
Facility	City	State or region	Status
Anne Arundel Urology, PA	Annapolis	Maryland	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Georgia Urology	Atlanta	Georgia	Recruiting
Urology Austin	Austin	Texas	Recruiting
MidLantic Urology	Bala-Cynwyd	Pennsylvania	Recruiting
Boise VA Medical Center	Boise	Idaho	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	Recruiting
Great Lakes Physician PC d/b/a Western new York Urology Associates	Cheektowaga	New York	Recruiting
University of Cincinnati	Cincinnati	Ohio	Recruiting
OSU Arthur James Cancer Hospital	Columbus	Ohio	Recruiting
Urology Clinics of North Texas PLLC (Dallas)	Dallas	Texas	Recruiting
University of Texas Southwestern Medical Center - Urology Clinic	Dallas	Texas	Recruiting
Advent Health	Denver	Colorado	Recruiting

26 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

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

https://xmedica.io/trials/ctgov/NCT06545955

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

France

Poland

South Korea

Spain

United States

Study documents

Changes over time