xMedica

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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 participants recherchés107 sites9 pays

Catégories

Oncologie62%Néphrologie et urologie38%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

Cette étude vous intéresse ?

Se connecter ou créez un compte pour manifester votre intérêt et suivre cette étude.

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.

Résumé

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

Affections

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuNONE (0)
Recrutement454 participants recherchés

Promoteur et collaborateurs

  • Ferring Pharmaceuticals Promoteur

Groupes et interventions

  • 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. .

Interventions

  • Médicament Nadofaragene Firadenovec

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

Critères de jugement

  1. Critère de jugement 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.

    Délai 24 months

  2. Critère de jugement secondaire

    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

    Délai up to 24 months

  3. Critère de jugement secondaire

    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

    Délai 12 months

  4. Critère de jugement secondaire

    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

    Délai 24 Months

Dates

Date de début1 octobre 2024 (réelle)
Achèvement principal30 juin 2028 (estimée)
Achèvement30 juin 2031 (estimée)
Première publication19 juillet 2024 (réelle)
Dernière mise à jour4 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foismai 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

105 sites sont en recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
G kenneth Jansz Medicine Professional CorporationBurlingtonOntarioEn recrutement
Prostate Cancer CentreCalgaryAlbertaEn recrutement
University Health Network UHN - Princess Margaret Cancer CentreTorontoOntarioEn recrutement

Czechia

ÉtablissementVilleÉtat ou régionStatut
Kromerizska Nemocnice A SKroměřížEn recrutement
Krajska Nemocnice LiberecLiberecEn recrutement
Fakultní Thomayerova NemocnicePraguePragueEn recrutement
Fakultní Thomayerova NemocnicePragueEn recrutement
Androgeos, spol. s r.o. LocationPraguePragueEn recrutement

Denmark

ÉtablissementVilleÉtat ou régionStatut
Aarhus University HospitalAarhusEn recrutement

France

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

Japan

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

Poland

ÉtablissementVilleÉtat ou régionStatut
IN-VIVO BydgoszczBydgoszczKuyavian-Pomeranian VoivodeshipEn recrutement
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.PoznanWielkopolskaEn recrutement
Medical Concierge Centrum MedyczneWarsawWoj. MazowieckieEn recrutement

South Korea

ÉtablissementVilleÉtat ou régionStatut
National Cancer CenterGoyang-siGyeonggi-doEn recrutement
Samsung Medical CenterSeoulSeoulEn recrutement
Korea University Anam HospitalSeoulSeoulEn recrutement
Seoul National University HospitalSeoulSongpa-guEn recrutement
Asan Medical CenterSeoulSongpa-guEn recrutement
Pusan National University Yangsan HospitalYangsanGyeongsangnam-doEn recrutement

Spain

ÉtablissementVilleÉtat ou régionStatut
Hospital Universitario de A CorunaA CoruñaGaliciaEn recrutement
Hospital Universitario Fundacion AlcorconAlcorcónMadridEn recrutement
Hospital del MarBarcelonaCataloniaEn recrutement
Hospital Universitario BasurtoBilbaoVizcayaEn recrutement
Hospital Universitario Reina SofiaCórdobaCórdobaEn recrutement
Hospital Universitario Virgen De Las NievesGranadaGranadaEn recrutement

57 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 4 septembre 2026

    Site ajouté

    1 site added (107 total)

    106107

  2. 6 août 2026

    Site ajouté

    3 sites added (106 total)

    103106

Registre: ClinicalTrials.gov · NCT########

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