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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati107 centri9 paesi

Categorie

Oncologia62%Nefrologia e urologia38%

Registrato in 1 registro

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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.

Sintesi

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

Patologie

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento454 partecipanti ricercati

Sponsor e collaboratori

  • Ferring Pharmaceuticals Sponsor

Bracci e interventi

  • 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. .

Interventi

  • Farmaco Nadofaragene Firadenovec

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

Esiti misurati

  1. Esito primario

    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.

    Orizzonte temporale 24 months

  2. Esito secondario

    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

    Orizzonte temporale up to 24 months

  3. Esito secondario

    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

    Orizzonte temporale 12 months

  4. Esito secondario

    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

    Orizzonte temporale 24 Months

Date

Data di inizio1 ottobre 2024 (effettiva)
Conclusione primaria30 giugno 2028 (stimata)
Conclusione30 giugno 2031 (stimata)
Prima pubblicazione19 luglio 2024 (effettiva)
Ultimo aggiornamento4 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltamaggio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

105 centri stanno reclutando

Canada

StrutturaCittàStato o regioneStato
G kenneth Jansz Medicine Professional CorporationBurlingtonOntarioIn reclutamento
Prostate Cancer CentreCalgaryAlbertaIn reclutamento
University Health Network UHN - Princess Margaret Cancer CentreTorontoOntarioIn reclutamento

Czechia

StrutturaCittàStato o regioneStato
Kromerizska Nemocnice A SKroměřížIn reclutamento
Krajska Nemocnice LiberecLiberecIn reclutamento
Fakultní Thomayerova NemocnicePraguePragueIn reclutamento
Fakultní Thomayerova NemocnicePragueIn reclutamento
Androgeos, spol. s r.o. LocationPraguePragueIn reclutamento

Denmark

StrutturaCittàStato o regioneStato
Aarhus University HospitalAarhusIn reclutamento

France

StrutturaCittàStato o regioneStato
CHU de Bordeaux - Hôpital PellegrinBordeauxNew AquitaineIn reclutamento
CHU Clermont Ferrand - Hopital Gabriel MontpiedClermont-FerrandAuvergne-Rhône-AlpesIn reclutamento
Hospices Civils de Lyon - Edouard Herriot Hosp.LyonRhône-AlpsIn reclutamento
Centre Hospitaliser Universitaire de Lyon SudLyonRhone-AlpeIn reclutamento
CHU Nantes - Hotel DieuNantesNantesIn reclutamento
Centre Hospitalier Universitaire De Nimes (Nîmes)NîmesOccitanieIn reclutamento
Hopital La Pitie SalpetriereParisIn reclutamento
APHP - Hopital BichatParisÎle-de-France RegionIn reclutamento
CHU de Rouen - Hopital Charles-NicolleRouenNormandyIn reclutamento
CHU Toulouse - Hopital RangueilToulouseHaute-GaronneIn reclutamento

Japan

StrutturaCittàStato o regioneStato
Institute of Science Tokyo HospitalBunkyō-KuTokyoIn reclutamento
Kyushu University HospitalFukuokaFukuokaIn reclutamento
Hiroshima University HospitalHiroshimaHiroshimaIn reclutamento
Hitachi General HospitalHitachiIbarakiIn reclutamento
Nara Medical University HospitalKashiharaNaraIn reclutamento
St. Marianna University HospitalKawasakiKanagawaIn reclutamento
Kobe University HospitalKobeHyōgoIn reclutamento
National Hospital Organization Shikoku Cancer CenterMatsuyamaEhimeIn reclutamento
Aichi Medical University HospitalNagakuteAichi-kenIn reclutamento
Nagoya University HospitalNagoyaAichi-kenIn reclutamento
Kochi Medical School HospitalNankokuKochiIn reclutamento
Japanese Red Cross Narita HospitalNaritaChibaIn reclutamento
Mie University HospitalTsuMie-kenIn reclutamento
University of Tsukuba HospitalTsukubaIbarakiIn reclutamento
Wakayama Medical University HospitalWakayamaWakayamaIn reclutamento
Yokohama City University HospitalYokohamaKanagawaIn reclutamento

Poland

StrutturaCittàStato o regioneStato
IN-VIVO BydgoszczBydgoszczKuyavian-Pomeranian VoivodeshipIn reclutamento
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.PoznanWielkopolskaIn reclutamento
Medical Concierge Centrum MedyczneWarsawWoj. MazowieckieIn reclutamento

South Korea

StrutturaCittàStato o regioneStato
National Cancer CenterGoyang-siGyeonggi-doIn reclutamento
Samsung Medical CenterSeoulSeoulIn reclutamento
Korea University Anam HospitalSeoulSeoulIn reclutamento
Seoul National University HospitalSeoulSongpa-guIn reclutamento
Asan Medical CenterSeoulSongpa-guIn reclutamento
Pusan National University Yangsan HospitalYangsanGyeongsangnam-doIn reclutamento

Spain

StrutturaCittàStato o regioneStato
Hospital Universitario de A CorunaA CoruñaGaliciaIn reclutamento
Hospital Universitario Fundacion AlcorconAlcorcónMadridIn reclutamento
Hospital del MarBarcelonaCataloniaIn reclutamento
Hospital Universitario BasurtoBilbaoVizcayaIn reclutamento
Hospital Universitario Reina SofiaCórdobaCórdobaIn reclutamento
Hospital Universitario Virgen De Las NievesGranadaGranadaIn reclutamento

Nella scheda del registro sono indicati altri 57 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 4 settembre 2026

    Centro aggiunto

    1 site added (107 total)

    106107

  2. 6 agosto 2026

    Centro aggiunto

    3 sites added (106 total)

    103106

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

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