En studie av TAR-200 versus intravesikal kjemoterapi hos deltakere med tilbakevendende høyrisiko ikke-muskelinvasiv blærekreft (HR-NMIBC) etter Bacillus Calmette-Guérin (BCG) (SunRISe-5)
2. november 2026 oppdatert av: Janssen Research & Development, LLC
En fase 3, randomisert, åpen, multisenterstudie som evaluerer effektiviteten og sikkerheten til TAR-200 versus etterforskerens valg av intravesikal kjemoterapi hos deltakere som mottok Bacillus Calmette-Guérin (BCG) og gjentok seg med høyrisiko ikke-muskel- invasiv blærekreft (HR-NMIBC) og som ikke er kvalifisert for eller valgt til ikke å gjennomgå 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.
Studieoversikt
Status
Status
Aktiv, ikke rekrutterende
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Intervensjonell
Registrering (Faktiske)
Registrering
272
Fase
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
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
-
-
-
-
-
Bruges, Belgia, 8000
- AZ Sint-Jan
-
Brussels, Belgia, 1200
- Cliniques Universitaires Saint Luc
-
Genk, Belgia, 3600
- Ziekenhuis Oost-Limburg
-
Ghent, Belgia, 9000
- Algemeen ziekenhuis Maria Middelares
-
Roeselare, Belgia, 8800
- Algemeen Ziekenhuis Delta
-
-
-
-
-
Barretos, Brasil, 14784-400
- Fundacao Pio XII
-
Bauru, Brasil, 17030-495
- NAIC Nair Antunes Instituto do Cancer
-
Campinas, Brasil, 13083-872
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
-
Curitiba, Brasil, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
-
Porto Alegre, Brasil, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
-
Salvador, Brasil, 41810-011
- Hospital da Bahia
-
São Paulo, Brasil, 01308 901
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
-
São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
-
São Paulo, Brasil, 01323 900
- Real e Benemérita Associação Portuguesa de Beneficência
-
-
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72211
- Arkansas Urology
-
-
California
-
Los Alamitos, California, Forente stater, 90720
- Genesis Research LLC 1
-
Los Angeles, California, Forente stater, 90033
- USC Norris Comprehensive Cancer Center
-
Orange, California, Forente stater, 92868
- University of California Irvine Medical Center
-
San Francisco, California, Forente stater, 94158 2549
- University of California San Francisco
-
Torrance, California, Forente stater, 90503
- Genesis Research LLC
-
-
Colorado
-
Lakewood, Colorado, Forente stater, 80228
- Colorado Clinical Research
-
-
Florida
-
Riverview, Florida, Forente stater, 33578
- Florida Urology Partners
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University
-
Chicago Ridge, Illinois, Forente stater, 60415
- UroPartners
-
-
Indiana
-
Carmel, Indiana, Forente stater, 46032
- Urology of Indiana
-
Jeffersonville, Indiana, Forente stater, 47130
- First Urology, PSC
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67226
- Wichita Urology Group
-
-
Michigan
-
Royal Oak, Michigan, Forente stater, 48073
- Comprehensive Urology
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63141
- Specialty Clinical Research of St Louis
-
-
New York
-
Syracuse, New York, Forente stater, 13210
- Associated Medical Professionals
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45212
- The Urology Group
-
Gahanna, Ohio, Forente stater, 43230
- Central Ohio Urology Group
-
-
Pennsylvania
-
Bala-Cynwyd, Pennsylvania, Forente stater, 19004
- Centers for Advanced Urology LLC d b a MidLantic Urology
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
-
Myrtle Beach, South Carolina, Forente stater, 29572
- Carolina Urologic Research Center
-
North Charleston, South Carolina, Forente stater, 29406
- Low Country Urology Clinics
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Forente stater, 37209
- Urology Associates
-
-
Texas
-
Austin, Texas, Forente stater, 78759
- Urology Austin
-
Dallas, Texas, Forente stater, 75390
- University of Texas Southwestern Medical Center
-
Dallas, Texas, Forente stater, 75231
- Urology Clinics of North Texas
-
Houston, Texas, Forente stater, 77027
- Houston Metro Urology
-
-
Washington
-
Spokane, Washington, Forente stater, 99202
- Spokane Urology
-
-
-
-
-
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
-
-
-
-
-
Arezzo, Italia, 52100
- Ospedale San Donato
-
Milan, Italia, 20132
- San Raffaele Hospital
-
Milan, Italia, 20133
- Istituto Dei Tumori Di Milano
-
Province of Macerata, Italia, 62100
- Ospedale Provinciale di Macerata
-
Ravenna, Italia, 48121
- Ospedale S. Maria Delle Croci
-
Roma, Italia, 00144
- Istituto Nazionale Tumori Regina Elena
-
Roma, Italia, 00128
- Universita Campus Bio-Medico di Roma
-
Rozzano, Italia, 20089
- Istituto Clinico Humanitas
-
Torino, Italia, 10126
- PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
Brasov, Romania, 500091
- Centrul Medical Unirea SRL
-
Bucharest, Romania, 014142
- Ponderas Academic Hospital
-
Cluj-Napoca, Romania, 400015
- Institutul Oncologic Ion Chiricuta
-
Cluj-Napoca, Romania, 400117
- Regina Maria
-
Timișoara, Romania, 300723
- Spitalul Clinic Judetean de Urgenta Pius Brinzeu
-
-
-
-
-
Badalona, Spania, 08916
- Hosp. Univ. Germans Trias I Pujol
-
Barcelona, Spania, 08025
- Fund. Puigvert
-
Madrid, Spania, 28041
- Hosp. Univ. 12 de Octubre
-
Madrid, Spania, 28007
- Hosp. Gral. Univ. Gregorio Maranon
-
Málaga, Spania, 29010
- Hosp Virgen de La Victoria
-
Sabadell, Spania, 08208
- Hosp.Univ.Parc Tauli
-
Santander, Spania, 39008
- Hosp. Univ. Marques de Valdecilla
-
Seville, Spania, 41013
- Hosp. Virgen Del Rocio
-
Valencia, Spania, 46010
- Hosp. Clinico Univ. de Valencia
-
-
-
-
-
London, Storbritannia, EC1A 7BE
- St Bartholomews Hospital
-
Salford, Storbritannia, M6 8HD
- Salford Royal Hospital
-
Southampton, Storbritannia, SO16 6YD
- Southampton University Hospital
-
Stevenage, Storbritannia, SG1 4AB
- Lister Hospital
-
-
-
-
-
Chungcheongbuk Do, Sør -Korea, 28644
- Chungbuk National University Hospital
-
Daegu, Sør -Korea, 42601
- Keimyung University Dongsan Hospital
-
Gyeonggi-do, Sør -Korea, 10408
- National Cancer Center
-
Jeollanam-do, Sør -Korea, 58128
- Chonnam National University Hwasun Hospital
-
Seoul, Sør -Korea, 03080
- Seoul National University Hospital
-
Seoul, Sør -Korea, 06351
- Samsung Medical Center
-
Seoul, Sør -Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
-
Yangsan, Sør -Korea, 50612
- Pusan National University Yangsan Hospital
-
-
-
-
-
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
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
2
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Participants will receive TAR-200 intravesically.
Andre navn:
|
|
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. |
Participants will receive MMC intravesically. Participants will receive gemcitabine intravesically. |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-free Survival (DFS)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence-Free Survival (RFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Sponsor
Etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
9. april 2024
Primær fullføring (Antatt)
Primær fullføring
27. november 2030
Studiet fullført (Antatt)
Studiet fullført
14. april 2031
Datoer for studieregistrering
Først innsendt
Først innsendt
9. januar 2024
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
9. januar 2024
Først lagt ut (Faktiske)
Først lagt ut
18. januar 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Urologiske neoplasmer
- Karsinom
- Urinblæresykdommer
- Neoplasmer i urinblæren
- Ikke-muskelinvasive blære-neoplasmer
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Indoler
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Kinoner
- Aziriner
- Mitomycins
- Indolekinoner
- Gemcitabin
- Mitomycin
Andre studie-ID-numre
Andre studie-ID-numre
- 17000139BLC3004
- 17000139BLC3004 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-507685-10-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .