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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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

שלב 3דרושים 454 משתתפים107 אתרים9 מדינות

קטגוריות

אונקולוגיה62%נפרולוגיה ואורולוגיה38%

רשום במרשם אחד

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.

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

תקציר

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

מצבים רפואיים

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

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

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 454 משתתפים

נותן חסות ושותפים

  • Ferring Pharmaceuticals נותן חסות

זרועות והתערבויות

  • 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. .

התערבויות

  • תרופה Nadofaragene Firadenovec

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

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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.

    מסגרת זמן 24 months

  2. מדד תוצאה משני

    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

    מסגרת זמן up to 24 months

  3. מדד תוצאה משני

    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

    מסגרת זמן 12 months

  4. מדד תוצאה משני

    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

    מסגרת זמן 24 Months

תאריכים

תאריך התחלה1 באוקטובר 2024 (בפועל)
סיום ראשוני30 ביוני 2028 (משוער)
סיום30 ביוני 2031 (משוער)
פורסם לראשונה19 ביולי 2024 (בפועל)
עודכן לאחרונה4 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהמאי 2026

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

מיקומים

105 אתרים מגייסים

Canada

מתקןעירמדינה או אזורמצב
G kenneth Jansz Medicine Professional CorporationBurlingtonOntarioמגייס
Prostate Cancer CentreCalgaryAlbertaמגייס
University Health Network UHN - Princess Margaret Cancer CentreTorontoOntarioמגייס

Czechia

מתקןעירמדינה או אזורמצב
Kromerizska Nemocnice A SKroměřížמגייס
Krajska Nemocnice LiberecLiberecמגייס
Fakultní Thomayerova NemocnicePraguePragueמגייס
Fakultní Thomayerova NemocnicePragueמגייס
Androgeos, spol. s r.o. LocationPraguePragueמגייס

Denmark

מתקןעירמדינה או אזורמצב
Aarhus University HospitalAarhusמגייס

France

מתקןעירמדינה או אזורמצב
CHU de Bordeaux - Hôpital PellegrinBordeauxNew Aquitaineמגייס
CHU Clermont Ferrand - Hopital Gabriel MontpiedClermont-FerrandAuvergne-Rhône-Alpesמגייס
Hospices Civils de Lyon - Edouard Herriot Hosp.LyonRhône-Alpsמגייס
Centre Hospitaliser Universitaire de Lyon SudLyonRhone-Alpeמגייס
CHU Nantes - Hotel DieuNantesNantesמגייס
Centre Hospitalier Universitaire De Nimes (Nîmes)NîmesOccitanieמגייס
Hopital La Pitie SalpetriereParisמגייס
APHP - Hopital BichatParisÎle-de-France Regionמגייס
CHU de Rouen - Hopital Charles-NicolleRouenNormandyמגייס
CHU Toulouse - Hopital RangueilToulouseHaute-Garonneמגייס

Japan

מתקןעירמדינה או אזורמצב
Institute of Science Tokyo HospitalBunkyō-KuTokyoמגייס
Kyushu University HospitalFukuokaFukuokaמגייס
Hiroshima University HospitalHiroshimaHiroshimaמגייס
Hitachi General HospitalHitachiIbarakiמגייס
Nara Medical University HospitalKashiharaNaraמגייס
St. Marianna University HospitalKawasakiKanagawaמגייס
Kobe University HospitalKobeHyōgoמגייס
National Hospital Organization Shikoku Cancer CenterMatsuyamaEhimeמגייס
Aichi Medical University HospitalNagakuteAichi-kenמגייס
Nagoya University HospitalNagoyaAichi-kenמגייס
Kochi Medical School HospitalNankokuKochiמגייס
Japanese Red Cross Narita HospitalNaritaChibaמגייס
Mie University HospitalTsuMie-kenמגייס
University of Tsukuba HospitalTsukubaIbarakiמגייס
Wakayama Medical University HospitalWakayamaWakayamaמגייס
Yokohama City University HospitalYokohamaKanagawaמגייס

Poland

מתקןעירמדינה או אזורמצב
IN-VIVO BydgoszczBydgoszczKuyavian-Pomeranian Voivodeshipמגייס
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.PoznanWielkopolskaמגייס
Medical Concierge Centrum MedyczneWarsawWoj. Mazowieckieמגייס

South Korea

מתקןעירמדינה או אזורמצב
National Cancer CenterGoyang-siGyeonggi-doמגייס
Samsung Medical CenterSeoulSeoulמגייס
Korea University Anam HospitalSeoulSeoulמגייס
Seoul National University HospitalSeoulSongpa-guמגייס
Asan Medical CenterSeoulSongpa-guמגייס
Pusan National University Yangsan HospitalYangsanGyeongsangnam-doמגייס

Spain

מתקןעירמדינה או אזורמצב
Hospital Universitario de A CorunaA CoruñaGaliciaמגייס
Hospital Universitario Fundacion AlcorconAlcorcónMadridמגייס
Hospital del MarBarcelonaCataloniaמגייס
Hospital Universitario BasurtoBilbaoVizcayaמגייס
Hospital Universitario Reina SofiaCórdobaCórdobaמגייס
Hospital Universitario Virgen De Las NievesGranadaGranadaמגייס

57 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 4 בספטמבר 2026

    אתר נוסף

    1 site added (107 total)

    106107

  2. 6 באוגוסט 2026

    אתר נוסף

    3 sites added (106 total)

    103106

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

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