A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Status: Active_not_recruiting
Location: See all (123) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Urology
Little Rock
California
Genesis Research LLC
Los Alamitos
USC Norris Comprehensive Cancer Center
Los Angeles
University of California Irvine Medical Center
Orange
University of California San Francisco
San Francisco
Genesis Research LLC
Torrance
Colorado
Colorado Clinical Research
Lakewood
Florida
Florida Urology Partners
Riverview
Illinois
Northwestern University
Chicago
UroPartners
Chicago Ridge
Indiana
Urology of Indiana
Carmel
First Urology, PSC
Jeffersonville
Kansas
Wichita Urology Group
Wichita
Michigan
Comprehensive Urology
Royal Oak
Missouri
Specialty Clinical Research of St Louis
St Louis
New York
Associated Medical Professionals
Syracuse
Ohio
The Urology Group
Cincinnati
Central Ohio Urology Group
Gahanna
Pennsylvania
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-cynwyd
South Carolina
Ralph H. Johnson Veterans Affairs Medical Center
Charleston
Carolina Urologic Research Center
Myrtle Beach
Low Country Urology Clinics
North Charleston
Tennessee
Urology Associates
Nashville
Vanderbilt University Medical Center
Nashville
Texas
Urology Austin
Austin
University of Texas Southwestern Medical Center
Dallas
Urology Clinics of North Texas
Dallas
Houston Metro Urology
Houston
Washington
Spokane Urology
Spokane
Other Locations
Argentina
Clinica Santa Isabel
Buenos Aires
Investigaciones Clinico Moleculares (ICM)
Caba
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba
Centro Urologico Profesor Bengio
Córdoba
Hospital Privado de la Comunidad
Mar Del Plata
Belgium
AZ Sint-Jan
Bruges
Cliniques Universitaires Saint Luc
Brussels
Ziekenhuis Oost-Limburg
Genk
Algemeen ziekenhuis Maria Middelares
Ghent
Algemeen Ziekenhuis Delta
Roeselare
Brazil
Fundacao Pio XII
Barretos
NAIC Nair Antunes Instituto do Cancer
Bauru
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
Campinas
Liga Paranaense de Combate ao Cancer
Curitiba
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Hospital da Bahia
Salvador
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo
China
Peking University First Hospital
Beijing
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi
Chongqing Cancer Hospital
Chongqing
Sun Yat Sen University Cancer Center
Guangzhou
Shengjing Hospital Of China Medical University
Shenyang
The Second Hospital Of Tianjin Medical University
Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
Wuhan
Xi an Jiaotong University Hospital
Xi'an
France
Hopital Claude Huriez
Lille
Polyclinique de Limoges - Francois Chenieux
Limoges
Institut Paoli Calmettes
Marseille
APHP - Hopital Bichat - Claude Bernard
Paris
Clinique de la Croix du Sud
Quint-fonsegrives
Chu Rennes Hopital Pontchaillou
Rennes
Hopital Foch
Suresnes
Germany
Universitaetsklinikum Koeln
Cologne
Universitaetsklinikum Halle Saale
Halle
Klinikum Leverkusen gGmbH
Leverkusen
Universitatsklinikum Schleswig Holstein Campus Lubeck
Lübeck
Urologie Neandertal Praxis Mettmann
Mettmann
Klinikum der Universitaet Muenchen
München
Italy
Ospedale San Donato
Arezzo
Ospedale Provinciale di Macerata
Macerata
Istituto Dei Tumori Di Milano
Milan
San Raffaele Hospital
Milan
Ospedale S. Maria Delle Croci
Ravenna
Istituto Nazionale Tumori Regina Elena
Roma
Universita Campus Bio-Medico di Roma
Roma
Istituto Clinico Humanitas
Rozzano
PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino
Japan
Funabashi Municipal Medical Center
Funabashi Shi
Hakodate Goryoukaku Hospital
Hakodate
Hyogo Prefectural Amagasaki General Medical Center
Hyōgo
Niigata Cancer Center Hospital
Niigata
National Hospital Organization Okayama Medical Center
Okayama
Toho University Sakura Medical Center
Sakura
Toranomon Hospital
Tokyo
Yokohama City University Medical Center
Yokohama
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok
IN VIVO Sp. z o.o
Bydgoszcz
Szpital Uniwersytecki w Krakowie
Krakow
Uniwersytecki Szpital Kliniczny nr 4
Lublin
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl
Szpital Wojewodzki im Sw Lukasza SP ZOZ
Tarnów
MICS Centrum Medyczne Torun
Torun
Mazowiecki Szpital Onkologiczny
Wieliszew
Dolnoslaskie Centrum Onkologii
Wroclaw
Republic of Korea
Chungbuk National University Hospital
Chungcheongbuk Do
Keimyung University Dongsan Hospital
Daegu
National Cancer Center
Gyeonggi-do
Chonnam National University Hwasun Hospital
Jeollanam-do
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea Seoul St Mary s Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan
Romania
Centrul Medical Unirea SRL
Brasov
Ponderas Academic Hospital
Bucharest
Institutul Oncologic Ion Chiricuta
Cluj-napoca
Regina Maria
Cluj-napoca
Spitalul Clinic Judetean de Urgenta Pius Brinzeu
Timișoara
Spain
Hosp. Univ. Germans Trias I Pujol
Badalona
Fund. Puigvert
Barcelona
Hosp. Gral. Univ. Gregorio Maranon
Madrid
Hosp. Univ. 12 de Octubre
Madrid
Hosp Virgen de La Victoria
Málaga
Hosp.Univ.Parc Tauli
Sabadell
Hosp. Univ. Marques de Valdecilla
Santander
Hosp. Virgen Del Rocio
Seville
Hosp. Clinico Univ. de Valencia
Valencia
United Kingdom
St Bartholomews Hospital
London
Salford Royal Hospital
Salford
Southampton University Hospital
Southampton
Lister Hospital
Stevenage
Time Frame
Start Date: 2024-04-09
Completion Date: 2031-04-14
Participants
Target number of participants: 272
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC