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En studie av TAR-200 kontra intravesikal kemoterapi hos deltagare med återkommande högrisk icke-muskelinvasiv blåscancer (HR-NMIBC) efter Bacillus Calmette-Guérin (BCG) (SunRISe-5)

2 november 2026 uppdaterad av: Janssen Research & Development, LLC

En fas 3, randomiserad, öppen, multicenterstudie som utvärderar effektiviteten och säkerheten av TAR-200 kontra utredarens val av intravesikal kemoterapi hos deltagare som fick Bacillus Calmette-Guérin (BCG) och återkom med högrisk-icke-muskel- invasiv blåscancer (HR-NMIBC) och som inte är berättigade till eller utvalda att inte genomgå radikal cystektomi

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

272

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Buenos Aires, Argentina, C1406
        • Clinica Santa Isabel
      • CABA, Argentina, C1425
        • Investigaciones Clinico Moleculares (ICM)
      • Córdoba, Argentina, 5000
        • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
      • Córdoba, Argentina, X5000KPH
        • Centro Urologico Profesor Bengio
      • Mar del Plata, Argentina, B7602
        • Hospital Privado de la Comunidad
  • Belgien
      • Bruges, Belgien, 8000
        • AZ Sint-Jan
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint Luc
      • Genk, Belgien, 3600
        • Ziekenhuis Oost-Limburg
      • Ghent, Belgien, 9000
        • Algemeen ziekenhuis Maria Middelares
      • Roeselare, Belgien, 8800
        • Algemeen Ziekenhuis Delta
  • Brasilien
      • Barretos, Brasilien, 14784-400
        • Fundacao Pio XII
      • Bauru, Brasilien, 17030-495
        • NAIC Nair Antunes Instituto do Cancer
      • Campinas, Brasilien, 13083-872
        • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
      • Curitiba, Brasilien, 81520-060
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Porto Alegre, Brasilien, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Salvador, Brasilien, 41810-011
        • Hospital da Bahia
      • São Paulo, Brasilien, 01308 901
        • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
      • São Paulo, Brasilien, 01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brasilien, 01323 900
        • Real e Benemérita Associação Portuguesa de Beneficência
  • Frankrike
      • Lille, Frankrike, 59000
        • Hopital Claude Huriez
      • Limoges, Frankrike, 87000
        • Polyclinique de Limoges - Francois Chenieux
      • Marseille, Frankrike, 13009
        • Institut Paoli Calmettes
      • Paris, Frankrike, 75018
        • APHP - Hopital Bichat - Claude Bernard
      • Quint-Fonsegrives, Frankrike, 31130
        • Clinique de la Croix du Sud
      • Rennes, Frankrike, 35000
        • Chu Rennes Hopital Pontchaillou
      • Suresnes, Frankrike, 92150
        • Hopital Foch
  • Förenta staterna
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72211
        • Arkansas Urology
    • California
      • Los Alamitos, California, Förenta staterna, 90720
        • Genesis Research LLC 1
      • Los Angeles, California, Förenta staterna, 90033
        • USC Norris Comprehensive Cancer Center
      • Orange, California, Förenta staterna, 92868
        • University of California Irvine Medical Center
      • San Francisco, California, Förenta staterna, 94158 2549
        • University of California San Francisco
      • Torrance, California, Förenta staterna, 90503
        • Genesis Research LLC
    • Colorado
      • Lakewood, Colorado, Förenta staterna, 80228
        • Colorado Clinical Research
    • Florida
      • Riverview, Florida, Förenta staterna, 33578
        • Florida Urology Partners
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University
      • Chicago Ridge, Illinois, Förenta staterna, 60415
        • UroPartners
    • Indiana
      • Carmel, Indiana, Förenta staterna, 46032
        • Urology of Indiana
      • Jeffersonville, Indiana, Förenta staterna, 47130
        • First Urology, PSC
    • Kansas
      • Wichita, Kansas, Förenta staterna, 67226
        • Wichita Urology Group
    • Michigan
      • Royal Oak, Michigan, Förenta staterna, 48073
        • Comprehensive Urology
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63141
        • Specialty Clinical Research of St Louis
    • New York
      • Syracuse, New York, Förenta staterna, 13210
        • Associated Medical Professionals
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45212
        • The Urology Group
      • Gahanna, Ohio, Förenta staterna, 43230
        • Central Ohio Urology Group
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, Förenta staterna, 19004
        • Centers for Advanced Urology LLC d b a MidLantic Urology
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29401
        • Ralph H. Johnson Veterans Affairs Medical Center
      • Myrtle Beach, South Carolina, Förenta staterna, 29572
        • Carolina Urologic Research Center
      • North Charleston, South Carolina, Förenta staterna, 29406
        • Low Country Urology Clinics
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Förenta staterna, 37209
        • Urology Associates
    • Texas
      • Austin, Texas, Förenta staterna, 78759
        • Urology Austin
      • Dallas, Texas, Förenta staterna, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, Förenta staterna, 75231
        • Urology Clinics of North Texas
      • Houston, Texas, Förenta staterna, 77027
        • Houston Metro Urology
    • Washington
      • Spokane, Washington, Förenta staterna, 99202
        • Spokane Urology
  • Italien
      • Arezzo, Italien, 52100
        • Ospedale San Donato
      • Milan, Italien, 20132
        • San Raffaele Hospital
      • Milan, Italien, 20133
        • Istituto Dei Tumori Di Milano
      • Province of Macerata, Italien, 62100
        • Ospedale Provinciale di Macerata
      • Ravenna, Italien, 48121
        • Ospedale S. Maria Delle Croci
      • Roma, Italien, 00144
        • Istituto Nazionale Tumori Regina Elena
      • Roma, Italien, 00128
        • Universita Campus Bio-Medico di Roma
      • Rozzano, Italien, 20089
        • Istituto Clinico Humanitas
      • Torino, Italien, 10126
        • PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
  • Japan
      • Funabashi Shi, Japan, 273 8588
        • Funabashi Municipal Medical Center
      • Hakodate, Japan, 040 8611
        • Hakodate Goryoukaku Hospital
      • Hyōgo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Sakura, Japan, 285-8741
        • Toho University Sakura Medical Center
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Yokohama, Japan, 232 0024
        • Yokohama City University Medical Center
  • Kina
      • Beijing, Kina, 100034
        • Peking University First Hospital
      • Cheng Du Shi, Kina, 610041
        • West China School of Medicine/West China Hospital, Sichuan University
      • Chongqing, Kina, 400033
        • Chongqing Cancer Hospital
      • Guangzhou, Kina, 510060
        • Sun Yat Sen University Cancer Center
      • Shenyang, Kina, 110055
        • Shengjing Hospital Of China Medical University
      • Tianjin, Kina, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Kina, 300211
        • The Second Hospital Of Tianjin Medical University
      • Wenzhou, Kina, 325015
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, Kina, 430032
        • Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
      • Xi'an, Kina, 710063
        • Xi an Jiaotong University Hospital
  • Polen
      • Bialystok, Polen, 15 276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bydgoszcz, Polen, 85 048
        • IN VIVO Sp. z o.o
      • Krakow, Polen, 30 688
        • Szpital Uniwersytecki w Krakowie
      • Lublin, Polen, 20 090
        • Uniwersytecki Szpital Kliniczny nr 4
      • Przemyśl, Polen, 37 700
        • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
      • Tarnów, Polen, 33 100
        • Szpital Wojewodzki im Sw Lukasza SP ZOZ
      • Torun, Polen, 87-100
        • MICS Centrum Medyczne Torun
      • Wieliszew, Polen, 05-135
        • Mazowiecki Szpital Onkologiczny
      • Wroclaw, Polen, 53 413
        • Dolnoslaskie Centrum Onkologii
  • Rumänien
      • Brasov, Rumänien, 500091
        • Centrul Medical Unirea SRL
      • Bucharest, Rumänien, 014142
        • Ponderas Academic Hospital
      • Cluj-Napoca, Rumänien, 400015
        • Institutul Oncologic Ion Chiricuta
      • Cluj-Napoca, Rumänien, 400117
        • Regina Maria
      • Timișoara, Rumänien, 300723
        • Spitalul Clinic Judetean de Urgenta Pius Brinzeu
  • Spanien
      • Badalona, Spanien, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spanien, 08025
        • Fund. Puigvert
      • Madrid, Spanien, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanien, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Málaga, Spanien, 29010
        • Hosp Virgen de La Victoria
      • Sabadell, Spanien, 08208
        • Hosp.Univ.Parc Tauli
      • Santander, Spanien, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville, Spanien, 41013
        • Hosp. Virgen Del Rocio
      • Valencia, Spanien, 46010
        • Hosp. Clinico Univ. de Valencia
  • Storbritannien
      • London, Storbritannien, EC1A 7BE
        • St Bartholomews Hospital
      • Salford, Storbritannien, M6 8HD
        • Salford Royal Hospital
      • Southampton, Storbritannien, SO16 6YD
        • Southampton University Hospital
      • Stevenage, Storbritannien, SG1 4AB
        • Lister Hospital
  • Sydkorea
      • Chungcheongbuk Do, Sydkorea, 28644
        • Chungbuk National University Hospital
      • Daegu, Sydkorea, 42601
        • Keimyung University Dongsan Hospital
      • Gyeonggi-do, Sydkorea, 10408
        • National Cancer Center
      • Jeollanam-do, Sydkorea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Sydkorea, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Yangsan, Sydkorea, 50612
        • Pusan National University Yangsan Hospital
  • Tyskland
      • Cologne, Tyskland, 50937
        • Universitaetsklinikum Koeln
      • Halle, Tyskland, 06120
        • Universitaetsklinikum Halle Saale
      • Leverkusen, Tyskland, 51375
        • Klinikum Leverkusen gGmbH
      • Lübeck, Tyskland, 23538
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Mettmann, Tyskland, 40822
        • Urologie Neandertal Praxis Mettmann
      • München, Tyskland, 81377
        • Klinikum der Universitaet Muenchen

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]
  • Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
  • Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion Criteria:

  • Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
  • Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
  • A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
  • Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
  • Previous treatment with TAR-200

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Group A: TAR-200

Participants will receive intravesical TAR-200 every 3 weeks during an induction phase and every 12 weeks during a maintenance phase.
Läkemedel: TAR-200

Participants will receive TAR-200 intravesically.

Andra namn:
  • JNJ-17000139
Aktiv komparator: Group B: Mitomycin C (MMC) or Gemcitabine

Participants will receive either single agent intravesical MMC or gemcitabine every week during an induction phase and every 4 weeks during a maintenance phase.
Läkemedel: Mitomycin C

Participants will receive MMC intravesically.

Läkemedel: Gemcitabine

Participants will receive gemcitabine intravesically.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Disease-free Survival (DFS)
Tidsram: Up to 6 years 7 months

DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [high grade (HG) Ta, any T1 or carcinoma in situ (CIS)], progression, or death due to any cause, whichever occurs first.
Up to 6 years 7 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recurrence-Free Survival (RFS)
Tidsram: Up to 6 years 7 months

RFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), or death due to any cause, whichever occurs first.
Up to 6 years 7 months
Time to Next Intervention (TTNI)
Tidsram: Up to 6 years 7 months

TTNI will be measured as the time from randomization to the time of next intervention (localized or systemic) for the treatment of bladder cancer.
Up to 6 years 7 months
Time to Disease Worsening (TTDW)
Tidsram: Up to 6 years 7 months

TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).
Up to 6 years 7 months
Time to Progression (TTP)
Tidsram: Up to 6 years 7 months

TTP will be measured as the time from randomization to the time of first documented evidence of disease progression (that is, progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node disease [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.
Up to 6 years 7 months
Overall Survival (OS)
Tidsram: Up to 6 years 7 months

OS is defined as the time from randomization to death, due to any cause.
Up to 6 years 7 months
DFS Rate at 12 and 24 Months
Tidsram: At 12 and 24 months

DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.
At 12 and 24 months
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
Tidsram: Up to 6 years 7 months

Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.
Up to 6 years 7 months
Number of Participants With Change from Baseline in Laboratory Abnormalities
Tidsram: Up to 6 years 7 months

Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported.
Up to 6 years 7 months
Number of Participants With Change from Baseline in Vital Signs Abnormalities
Tidsram: Up to 6 years 7 months

Number of participants with change from baseline in vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.
Up to 6 years 7 months
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores
Tidsram: Up to 5 years

EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).
Up to 5 years
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Tidsram: Up to 5 years

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much).
Up to 5 years
Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores
Tidsram: Up to 5 years

Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported.
Up to 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Utredare

  • Studierektor: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 april 2024

Primärt slutförande (Beräknad)

27 november 2030

Avslutad studie (Beräknad)

14 april 2031

Studieregistreringsdatum

Först inskickad

9 januari 2024

Först inskickad som uppfyllde QC-kriterierna

9 januari 2024

Första postat (Faktisk)

18 januari 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 17000139BLC3004
  • 17000139BLC3004 (Annan identifierare: Janssen Research & Development, LLC)
  • 2023-507685-10-00 (Registeridentifierare: EUCT number)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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