Clinical trial NCT06211764: A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Muscle Invasive Bladder Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: Up to 6 years 7 months
Secondary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: Up to 6 years 7 months
measure: Time to Next Intervention (TTNI)
timeFrame: Up to 6 years 7 months
measure: Time to Disease Worsening (TTDW)
timeFrame: Up to 6 years 7 months
measure: Time to Progression (TTP)
timeFrame: Up to 6 years 7 months
measure: Overall Survival (OS)
timeFrame: Up to 6 years 7 months
measure: DFS Rate at 12 and 24 Months
timeFrame: At 12 and 24 months
measure: Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Up to 6 years 7 months
measure: Number of Participants With Change from Baseline in Laboratory Abnormalities
timeFrame: Up to 6 years 7 months
measure: Number of Participants With Change from Baseline in Vital Signs Abnormalities
timeFrame: Up to 6 years 7 months
measure: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores
timeFrame: Up to 5 years
measure: Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
timeFrame: Up to 5 years
measure: Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Los Alamitos
country: United States
facility: Genesis Research LLC
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Torrance
country: United States
facility: Genesis Research LLC
state: California
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Riverview
country: United States
facility: Florida Urology Partners
state: Florida
city: Chicago Ridge
country: United States
facility: UroPartners
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St Louis
state: Missouri
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Centers for Advanced Urology LLC d b a MidLantic Urology
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson Veterans Affairs Medical Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: North Charleston
country: United States
facility: Low Country Urology Clinics
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
city: Buenos Aires
country: Argentina
facility: Clinica Santa Isabel
city: Caba
country: Argentina
facility: Investigaciones Clinico Moleculares (ICM)
city: Cordoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Mar del Plata
country: Argentina
facility: Hospital Privado de la Comunidad
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Algemeen ziekenhuis Maria Middelares
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Bauru
country: Brazil
facility: NAIC Nair Antunes Instituto do Cancer
city: Campinas
country: Brazil
facility: Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Salvador
country: Brazil
facility: Hospital da Bahia
city: Sao Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
city: Beijing
country: China
facility: Peking University First Hospital
city: Cheng Du Shi
country: China
facility: West China School of Medicine/West China Hospital, Sichuan University
city: Chong Qing
country: China
facility: Chongqing Cancer Hospital
city: Guang Zhou Shi
country: China
facility: Sun Yat Sen University Cancer Center
city: Shen Yang Shi
country: China
facility: Shengjing Hospital Of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Tianjin
country: China
facility: The Second Hospital Of Tianjin Medical University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Tongji Medical College of Huazhong University Science Technology of Medicine Health Management
city: XI An Shi
country: China
facility: Xi an Jiaotong University Hospital
city: Lille
country: France
facility: Hopital Claude Huriez
city: Limoges
country: France
facility: Polyclinique de Limoges - Francois Chenieux
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: APHP - Hopital Bichat - Claude Bernard
city: Quint-Fonsegrives
country: France
facility: Clinique de la Croix du Sud
city: Rennes
country: France
facility: Chu Rennes Hopital Pontchaillou
city: Suresnes
country: France
facility: Hopital Foch
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle Saale
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen gGmbH
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein Campus Lubeck
city: Mettmann
country: Germany
facility: Urologie Neandertal Praxis Mettmann
city: Munchen
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Macerata
country: Italy
facility: Ospedale Provinciale di Macerata
city: Milano
country: Italy
facility: San Raffaele Hospital
city: Milano
country: Italy
facility: Istituto Dei Tumori Di Milano
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Roma
country: Italy
facility: Universita Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: PO Molinette Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
city: Funabashi shi
country: Japan
facility: Funabashi Munitiple Medical Center
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Chungcheongbuk Do
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bydgoszcz
country: Poland
facility: IN VIVO Sp. z o.o
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 4
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
city: Tarnow
country: Poland
facility: Szpital Wojewodzki im Sw Lukasza SP ZOZ
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Brasov
country: Romania
facility: Centrul Medical Unirea SRL
city: Bucuresti
country: Romania
facility: Ponderas Academic Hospital
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Ion Chiricuta
city: Cluj-Napoca
country: Romania
facility: Regina Maria
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Pius Brinzeu
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Fund. Puigvert
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Sabadell
country: Spain
facility: Hosp.Univ.Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical trial
role: STUDY_DIRECTOR
References: