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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

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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 Teilnehmende gesucht107 Studienzentren9 Länder

Kategorien

Onkologie62%Nephrologie und Urologie38%

In 1 Register registriert

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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.

  • 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.

Zusammenfassung

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

Erkrankungen

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungNONE (0)
Teilnahme454 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Ferring Pharmaceuticals Sponsor

Studienarme und Interventionen

  • 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. .

Interventionen

  • Arzneimittel Nadofaragene Firadenovec

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

Endpunkte

  1. Primärer Endpunkt

    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.

    Zeitrahmen 24 months

  2. Sekundärer Endpunkt

    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

    Zeitrahmen up to 24 months

  3. Sekundärer Endpunkt

    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

    Zeitrahmen 12 months

  4. Sekundärer Endpunkt

    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

    Zeitrahmen 24 Months

Daten

Startdatum1. Oktober 2024 (tatsächlich)
Primärer Abschluss30. Juni 2028 (geschätzt)
Abschluss30. Juni 2031 (geschätzt)
Erstveröffentlichung19. Juli 2024 (tatsächlich)
Zuletzt aktualisiert4. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtMai 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

105 Studienzentren rekrutieren

Canada

EinrichtungStadtBundesland oder RegionStatus
G kenneth Jansz Medicine Professional CorporationBurlingtonOntarioRekrutiert
Prostate Cancer CentreCalgaryAlbertaRekrutiert
University Health Network UHN - Princess Margaret Cancer CentreTorontoOntarioRekrutiert

Czechia

EinrichtungStadtBundesland oder RegionStatus
Kromerizska Nemocnice A SKroměřížRekrutiert
Krajska Nemocnice LiberecLiberecRekrutiert
Fakultní Thomayerova NemocnicePraguePragueRekrutiert
Fakultní Thomayerova NemocnicePragueRekrutiert
Androgeos, spol. s r.o. LocationPraguePragueRekrutiert

Denmark

EinrichtungStadtBundesland oder RegionStatus
Aarhus University HospitalAarhusRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
CHU de Bordeaux - Hôpital PellegrinBordeauxNew AquitaineRekrutiert
CHU Clermont Ferrand - Hopital Gabriel MontpiedClermont-FerrandAuvergne-Rhône-AlpesRekrutiert
Hospices Civils de Lyon - Edouard Herriot Hosp.LyonRhône-AlpsRekrutiert
Centre Hospitaliser Universitaire de Lyon SudLyonRhone-AlpeRekrutiert
CHU Nantes - Hotel DieuNantesNantesRekrutiert
Centre Hospitalier Universitaire De Nimes (Nîmes)NîmesOccitanieRekrutiert
Hopital La Pitie SalpetriereParisRekrutiert
APHP - Hopital BichatParisÎle-de-France RegionRekrutiert
CHU de Rouen - Hopital Charles-NicolleRouenNormandyRekrutiert
CHU Toulouse - Hopital RangueilToulouseHaute-GaronneRekrutiert

Japan

EinrichtungStadtBundesland oder RegionStatus
Institute of Science Tokyo HospitalBunkyō-KuTokyoRekrutiert
Kyushu University HospitalFukuokaFukuokaRekrutiert
Hiroshima University HospitalHiroshimaHiroshimaRekrutiert
Hitachi General HospitalHitachiIbarakiRekrutiert
Nara Medical University HospitalKashiharaNaraRekrutiert
St. Marianna University HospitalKawasakiKanagawaRekrutiert
Kobe University HospitalKobeHyōgoRekrutiert
National Hospital Organization Shikoku Cancer CenterMatsuyamaEhimeRekrutiert
Aichi Medical University HospitalNagakuteAichi-kenRekrutiert
Nagoya University HospitalNagoyaAichi-kenRekrutiert
Kochi Medical School HospitalNankokuKochiRekrutiert
Japanese Red Cross Narita HospitalNaritaChibaRekrutiert
Mie University HospitalTsuMie-kenRekrutiert
University of Tsukuba HospitalTsukubaIbarakiRekrutiert
Wakayama Medical University HospitalWakayamaWakayamaRekrutiert
Yokohama City University HospitalYokohamaKanagawaRekrutiert

Poland

EinrichtungStadtBundesland oder RegionStatus
IN-VIVO BydgoszczBydgoszczKuyavian-Pomeranian VoivodeshipRekrutiert
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.PoznanWielkopolskaRekrutiert
Medical Concierge Centrum MedyczneWarsawWoj. MazowieckieRekrutiert

South Korea

EinrichtungStadtBundesland oder RegionStatus
National Cancer CenterGoyang-siGyeonggi-doRekrutiert
Samsung Medical CenterSeoulSeoulRekrutiert
Korea University Anam HospitalSeoulSeoulRekrutiert
Seoul National University HospitalSeoulSongpa-guRekrutiert
Asan Medical CenterSeoulSongpa-guRekrutiert
Pusan National University Yangsan HospitalYangsanGyeongsangnam-doRekrutiert

Spain

EinrichtungStadtBundesland oder RegionStatus
Hospital Universitario de A CorunaA CoruñaGaliciaRekrutiert
Hospital Universitario Fundacion AlcorconAlcorcónMadridRekrutiert
Hospital del MarBarcelonaCataloniaRekrutiert
Hospital Universitario BasurtoBilbaoVizcayaRekrutiert
Hospital Universitario Reina SofiaCórdobaCórdobaRekrutiert
Hospital Universitario Virgen De Las NievesGranadaGranadaRekrutiert

57 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 4. September 2026

    Studienzentrum hinzugefügt

    1 site added (107 total)

    106107

  2. 6. August 2026

    Studienzentrum hinzugefügt

    3 sites added (106 total)

    103106

Register: ClinicalTrials.gov · NCT########

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