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)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 3דרושים 250 משתתפים76 אתרים7 מדינות

קטגוריות

אונקולוגיה74%נפרולוגיה ואורולוגיה26%

רשום במרשם אחד

ClinicalTrials.govNCT06545955פתיחת רשומה זו ב־ClinicalTrials.govסונכרן החודש שעבר

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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).

מצבים רפואיים

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 250 משתתפים

נותן חסות ושותפים

Ferring Pharmaceuticals נותן חסות

זרועות והתערבויות

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.

התערבויות

תרופה Docetaxel
Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
תרופה Gemcitabine
Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
תרופה 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.
תרופה 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.

מדדי תוצאה

מדד תוצאה ראשוני
Complete response
Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence).
מסגרת זמן up to 6 months
מדד תוצאה משני
Complete response at month 6
Complete response 6 months from first treatment
מסגרת זמן 6 months
מדד תוצאה משני
Complete response at month 3
Complete response 3 months from first treatment
מסגרת זמן 3 months
מדד תוצאה משני
Durability of complete response
Durability of complete response (defined as time from achieved CR to HG recurrence, progression or death due to any cause).
מסגרת זמן Up to 24 months
מדד תוצאה משני
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)
מסגרת זמן up to 36 months
מדד תוצאה משני
Cystectomy-free survival
Cystectomy-free survival (defined as time from first treatment to either cystectomy or death due to any cause)
מסגרת זמן up to 36 months
מדד תוצאה משני
Pathological staging
Pathological staging (tumor, node, metastasis staging system) in participants at time of cystectomy
מסגרת זמן up to 36 months
מדד תוצאה משני
Overall survival
Overall survival (defined as time from first treatment to death due to any cause)
מסגרת זמן up to 36 months
מדד תוצאה משני
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).
מסגרת זמן up to 24 months
מדד תוצאה משני
Adverse events
Adverse events collected for nadofaragene firadenovec in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab)
מסגרת זמן up to 36 months

תאריכים

תאריכים
תאריך התחלה	1 באוקטובר 2024 (בפועל)
סיום ראשוני	30 ביוני 2028 (משוער)
סיום	31 בדצמבר 2030 (משוער)
פורסם לראשונה	9 באוגוסט 2024 (בפועל)
עודכן לאחרונה	6 באוגוסט 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	נובמבר 2025

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

76 אתרים מגייסים

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
Prostate Cancer Centre	Calgary	Alberta	מגייס
Centre Hospitalier de L'Universite de Montreal	Montreal	Quebec	מגייס
University Health Network UHN - Princess Margaret Cancer Centre	Toronto	Ontario	מגייס

Czechia

Czechia
מתקן	עיר	מדינה או אזור	מצב
Kromerizska Nemocnice A S	Kroměříž	Zlín	מגייס
Krajska Nemocnice Liberec	Liberec	Liberec Region	מגייס
Fakultní Thomayerova Nemocnice	Prague	Prague	מגייס
Fakultni nemocnice v Motole	Prague	Prague	מגייס
Androgeos, spol. s r.o.	Prague	Prague	מגייס

France

France
מתקן	עיר	מדינה או אזור	מצב
CHU de Bordeaux - Hôpital Pellegrin	Bordeaux	New Aquitaine	מגייס
CHU Clermont Ferrand - Hopital Gabriel Montpied	Clermont-Ferrand	Auvergne-Rhône-Alpes	מגייס
Centre Hospitaliser Universitaire de Lyon Sud	Lyon	Rhone.Alpe	מגייס
Hospices Civils de Lyon - Edouard Herriot Hosp.	Lyon	Auvergne-Rhône-Alpes	מגייס
CHU Nantes - Hotel Dieu	Nantes	Nantes	מגייס
Centre Hospitalier Universitaire De Nimes (Nîmes)	Nîmes	Occitanie	מגייס
Hopital La Pitie Salpetriere	Paris		מגייס
APHP - Hopital Bichat	Paris	Île-de-France Region	מגייס
CHU Toulouse - Hopital Rangueil	Toulouse	Huate-Garonne	מגייס

Poland

Poland
מתקן	עיר	מדינה או אזור	מצב
IN-VIVO Bydgoszcz	Bydgoszcz	Kuyavian-Pomeranian Voivodeship	מגייס
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.	Poznan	Wielkopolska	מגייס
Medical Concierge Centrum Medyczne	Warsaw	Woj. Mazowieckie	מגייס

South Korea

South Korea
מתקן	עיר	מדינה או אזור	מצב
Seoul National University Hospital	Seoul	Songpa-gu	מגייס
Samsung Medical Center	Seoul	Seoul	מגייס
Korea University Anam Hospital	Seoul	Seoul	מגייס
Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do	מגייס

Spain

Spain
מתקן	עיר	מדינה או אזור	מצב
Hospital Universitario de A Coruna	A Coruña	Galicia	מגייס
Hospital Universitario Fundacion Alcorcon	Alcorcón	Madrid	מגייס
Hospital del Mar	Barcelona	Catalonia	מגייס
Hospital Clinic De Barcelona - University of Barcelona	Barcelona	Catalonia	מגייס
Hospital Universitario Basurto	Bilbao	Vizcaya	מגייס
Hospital Universitario Reina Sofia	Córdoba	Cordoba	מגייס
Clinica Universidad de Navarra - Madrid	Madrid	Madrid	מגייס
MD Anderson Cancer Center	Madrid		מגייס
Hospital Universitario 12 De Octubre (Madrid)	Madrid	Madrid	מגייס
Universidad Autonoma de Madrid. Hospital Universitario La Paz	Madrid	Madrid	מגייס
Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)	Málaga		מגייס
Clinica Universidad de Navarra - Pamplona	Pamplona	Navarre	מגייס
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla	Santander	Cantabria	מגייס

United States

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

26 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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