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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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En resumen

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

Fase 3454 participantes buscados107 centros9 países

Categorías

Oncología62%Nefrología y urología38%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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

Afecciones

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción454 participantes buscados

Patrocinador y colaboradores

  • Ferring Pharmaceuticals Patrocinador

Grupos e intervenciones

  • 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. .

Intervenciones

  • Fármaco Nadofaragene Firadenovec

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

Variables de resultado

  1. Variable de resultado principal

    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.

    Plazo 24 months

  2. Variable de resultado secundaria

    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

    Plazo up to 24 months

  3. Variable de resultado secundaria

    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

    Plazo 12 months

  4. Variable de resultado secundaria

    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

    Plazo 24 Months

Fechas

Fecha de inicio1 de octubre de 2024 (real)
Finalización principal30 de junio de 2028 (estimada)
Finalización30 de junio de 2031 (estimada)
Primera publicación19 de julio de 2024 (real)
Última actualización4 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezmayo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

105 centros están en reclutamiento

Canada

CentroCiudadEstado o regiónEstado
G kenneth Jansz Medicine Professional CorporationBurlingtonOntarioEn reclutamiento
Prostate Cancer CentreCalgaryAlbertaEn reclutamiento
University Health Network UHN - Princess Margaret Cancer CentreTorontoOntarioEn reclutamiento

Czechia

CentroCiudadEstado o regiónEstado
Kromerizska Nemocnice A SKroměřížEn reclutamiento
Krajska Nemocnice LiberecLiberecEn reclutamiento
Fakultní Thomayerova NemocnicePraguePragueEn reclutamiento
Fakultní Thomayerova NemocnicePragueEn reclutamiento
Androgeos, spol. s r.o. LocationPraguePragueEn reclutamiento

Denmark

CentroCiudadEstado o regiónEstado
Aarhus University HospitalAarhusEn reclutamiento

France

CentroCiudadEstado o regiónEstado
CHU de Bordeaux - Hôpital PellegrinBordeauxNew AquitaineEn reclutamiento
CHU Clermont Ferrand - Hopital Gabriel MontpiedClermont-FerrandAuvergne-Rhône-AlpesEn reclutamiento
Hospices Civils de Lyon - Edouard Herriot Hosp.LyonRhône-AlpsEn reclutamiento
Centre Hospitaliser Universitaire de Lyon SudLyonRhone-AlpeEn reclutamiento
CHU Nantes - Hotel DieuNantesNantesEn reclutamiento
Centre Hospitalier Universitaire De Nimes (Nîmes)NîmesOccitanieEn reclutamiento
Hopital La Pitie SalpetriereParisEn reclutamiento
APHP - Hopital BichatParisÎle-de-France RegionEn reclutamiento
CHU de Rouen - Hopital Charles-NicolleRouenNormandyEn reclutamiento
CHU Toulouse - Hopital RangueilToulouseHaute-GaronneEn reclutamiento

Japan

CentroCiudadEstado o regiónEstado
Institute of Science Tokyo HospitalBunkyō-KuTokyoEn reclutamiento
Kyushu University HospitalFukuokaFukuokaEn reclutamiento
Hiroshima University HospitalHiroshimaHiroshimaEn reclutamiento
Hitachi General HospitalHitachiIbarakiEn reclutamiento
Nara Medical University HospitalKashiharaNaraEn reclutamiento
St. Marianna University HospitalKawasakiKanagawaEn reclutamiento
Kobe University HospitalKobeHyōgoEn reclutamiento
National Hospital Organization Shikoku Cancer CenterMatsuyamaEhimeEn reclutamiento
Aichi Medical University HospitalNagakuteAichi-kenEn reclutamiento
Nagoya University HospitalNagoyaAichi-kenEn reclutamiento
Kochi Medical School HospitalNankokuKochiEn reclutamiento
Japanese Red Cross Narita HospitalNaritaChibaEn reclutamiento
Mie University HospitalTsuMie-kenEn reclutamiento
University of Tsukuba HospitalTsukubaIbarakiEn reclutamiento
Wakayama Medical University HospitalWakayamaWakayamaEn reclutamiento
Yokohama City University HospitalYokohamaKanagawaEn reclutamiento

Poland

CentroCiudadEstado o regiónEstado
IN-VIVO BydgoszczBydgoszczKuyavian-Pomeranian VoivodeshipEn reclutamiento
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.PoznanWielkopolskaEn reclutamiento
Medical Concierge Centrum MedyczneWarsawWoj. MazowieckieEn reclutamiento

South Korea

CentroCiudadEstado o regiónEstado
National Cancer CenterGoyang-siGyeonggi-doEn reclutamiento
Samsung Medical CenterSeoulSeoulEn reclutamiento
Korea University Anam HospitalSeoulSeoulEn reclutamiento
Seoul National University HospitalSeoulSongpa-guEn reclutamiento
Asan Medical CenterSeoulSongpa-guEn reclutamiento
Pusan National University Yangsan HospitalYangsanGyeongsangnam-doEn reclutamiento

Spain

CentroCiudadEstado o regiónEstado
Hospital Universitario de A CorunaA CoruñaGaliciaEn reclutamiento
Hospital Universitario Fundacion AlcorconAlcorcónMadridEn reclutamiento
Hospital del MarBarcelonaCataloniaEn reclutamiento
Hospital Universitario BasurtoBilbaoVizcayaEn reclutamiento
Hospital Universitario Reina SofiaCórdobaCórdobaEn reclutamiento
Hospital Universitario Virgen De Las NievesGranadaGranadaEn reclutamiento

En el registro figuran 57 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 4 de septiembre de 2026

    Centro añadido

    1 site added (107 total)

    106107

  2. 6 de agosto de 2026

    Centro añadido

    3 sites added (106 total)

    103106

Registro: ClinicalTrials.gov · NCT########

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