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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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

المرحلة 3مطلوب 454 مشاركاً107 مواقع9 دول

الفئات

علم الأورام62%الكلى والمسالك البولية38%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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

الحالات

  • Intermediate Risk Non-Muscle Invasive Bladder Cancer

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 454 مشاركاً

الجهة الراعية والمتعاونون

  • Ferring Pharmaceuticals الجهة الراعية

الأذرع والتدخلات

  • 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. .

التدخلات

  • دواء Nadofaragene Firadenovec

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

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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.

    الإطار الزمني 24 months

  2. مقياس النتيجة الثانوي

    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

    الإطار الزمني up to 24 months

  3. مقياس النتيجة الثانوي

    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

    الإطار الزمني 12 months

  4. مقياس النتيجة الثانوي

    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

    الإطار الزمني 24 Months

التواريخ

تاريخ البدء1 أكتوبر 2024 (فعلي)
الإتمام الأولي30 يونيو 2028 (تقديري)
الإتمام30 يونيو 2031 (تقديري)
أول نشر19 يوليو 2024 (فعلي)
آخر تحديث4 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةمايو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

105 مواقع قيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
G kenneth Jansz Medicine Professional CorporationBurlingtonOntarioقيد التجنيد
Prostate Cancer CentreCalgaryAlbertaقيد التجنيد
University Health Network UHN - Princess Margaret Cancer CentreTorontoOntarioقيد التجنيد

Czechia

المنشأةالمدينةالولاية أو المنطقةالحالة
Kromerizska Nemocnice A SKroměřížقيد التجنيد
Krajska Nemocnice LiberecLiberecقيد التجنيد
Fakultní Thomayerova NemocnicePraguePragueقيد التجنيد
Fakultní Thomayerova NemocnicePragueقيد التجنيد
Androgeos, spol. s r.o. LocationPraguePragueقيد التجنيد

Denmark

المنشأةالمدينةالولاية أو المنطقةالحالة
Aarhus University HospitalAarhusقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
CHU de Bordeaux - Hôpital PellegrinBordeauxNew Aquitaineقيد التجنيد
CHU Clermont Ferrand - Hopital Gabriel MontpiedClermont-FerrandAuvergne-Rhône-Alpesقيد التجنيد
Hospices Civils de Lyon - Edouard Herriot Hosp.LyonRhône-Alpsقيد التجنيد
Centre Hospitaliser Universitaire de Lyon SudLyonRhone-Alpeقيد التجنيد
CHU Nantes - Hotel DieuNantesNantesقيد التجنيد
Centre Hospitalier Universitaire De Nimes (Nîmes)NîmesOccitanieقيد التجنيد
Hopital La Pitie SalpetriereParisقيد التجنيد
APHP - Hopital BichatParisÎle-de-France Regionقيد التجنيد
CHU de Rouen - Hopital Charles-NicolleRouenNormandyقيد التجنيد
CHU Toulouse - Hopital RangueilToulouseHaute-Garonneقيد التجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Institute of Science Tokyo HospitalBunkyō-KuTokyoقيد التجنيد
Kyushu University HospitalFukuokaFukuokaقيد التجنيد
Hiroshima University HospitalHiroshimaHiroshimaقيد التجنيد
Hitachi General HospitalHitachiIbarakiقيد التجنيد
Nara Medical University HospitalKashiharaNaraقيد التجنيد
St. Marianna University HospitalKawasakiKanagawaقيد التجنيد
Kobe University HospitalKobeHyōgoقيد التجنيد
National Hospital Organization Shikoku Cancer CenterMatsuyamaEhimeقيد التجنيد
Aichi Medical University HospitalNagakuteAichi-kenقيد التجنيد
Nagoya University HospitalNagoyaAichi-kenقيد التجنيد
Kochi Medical School HospitalNankokuKochiقيد التجنيد
Japanese Red Cross Narita HospitalNaritaChibaقيد التجنيد
Mie University HospitalTsuMie-kenقيد التجنيد
University of Tsukuba HospitalTsukubaIbarakiقيد التجنيد
Wakayama Medical University HospitalWakayamaWakayamaقيد التجنيد
Yokohama City University HospitalYokohamaKanagawaقيد التجنيد

Poland

المنشأةالمدينةالولاية أو المنطقةالحالة
IN-VIVO BydgoszczBydgoszczKuyavian-Pomeranian Voivodeshipقيد التجنيد
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.PoznanWielkopolskaقيد التجنيد
Medical Concierge Centrum MedyczneWarsawWoj. Mazowieckieقيد التجنيد

South Korea

المنشأةالمدينةالولاية أو المنطقةالحالة
National Cancer CenterGoyang-siGyeonggi-doقيد التجنيد
Samsung Medical CenterSeoulSeoulقيد التجنيد
Korea University Anam HospitalSeoulSeoulقيد التجنيد
Seoul National University HospitalSeoulSongpa-guقيد التجنيد
Asan Medical CenterSeoulSongpa-guقيد التجنيد
Pusan National University Yangsan HospitalYangsanGyeongsangnam-doقيد التجنيد

Spain

المنشأةالمدينةالولاية أو المنطقةالحالة
Hospital Universitario de A CorunaA CoruñaGaliciaقيد التجنيد
Hospital Universitario Fundacion AlcorconAlcorcónMadridقيد التجنيد
Hospital del MarBarcelonaCataloniaقيد التجنيد
Hospital Universitario BasurtoBilbaoVizcayaقيد التجنيد
Hospital Universitario Reina SofiaCórdobaCórdobaقيد التجنيد
Hospital Universitario Virgen De Las NievesGranadaGranadaقيد التجنيد

يُدرَج 57 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 4 سبتمبر 2026

    أُضيف موقع

    1 site added (107 total)

    106107

  2. 6 أغسطس 2026

    أُضيف موقع

    3 sites added (106 total)

    103106

السجل: ClinicalTrials.gov · NCT########

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