A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Bladder Cancer Clinical Trial

— SunRISe-3  

Official title:

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714202
• Other study ID #: CR109223
• Secondary ID: 2020-004506-6417
• Status: Recruiting
• Phase: Phase 3
• Start date: March 23, 2023
• Est. completion date: September 18, 2029

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Description:

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: September 18, 2029
• Est. primary completion date: September 18, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve

• BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)

• All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)

• Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

• All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization

• Participants must be willing to undergo all study procedures

Exclusion Criteria:

• Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)

• Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization

• Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. 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 (mL)

• Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• TAR-200
TAR-200 will be administered intravesically.

Biological:
• Cetrelimab
Cetrelimab will be administered.
• BCG Vesiculture
BCG will be administered intravesically.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	Buenos Aires
Argentina	Centro Urologico Profesor Bengio	Cordoba
Argentina	Hospital Privado - Centro Medico de Cordoba	Cordoba
Argentina	Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica	Córdoba
Argentina	Hospital Privado de la Comunidad	Mar del Plata
Argentina	Instituto Medico Rio Cuarto	Rio Cuarto
Australia	Austin Health	Heidelberg
Australia	Macquarie University Hospital	Macquarie University
Australia	Hollywood Private Hospital	Nedlands
Australia	Mater Hospital Brisbane	South Brisbane
Belgium	ZNA Middelheim	Antwerpen
Belgium	AZ Sint-Jan	Brugge
Belgium	AZ Sint-Lucas	Brugge
Belgium	AZ Maria Middelares	Gent
Belgium	UZ Gent	Gent
Belgium	Centre Hospitalier de l'Ardenne	Libramont-Chevigny
Belgium	AZ Delta	Roeselare
Belgium	Vitaz	Sint-Niklaas
Belgium	GZA Ziekenhuizen- Campus St Augustinus	Wilrijk
Brazil	Fundacao Pio XII	Barretos
Brazil	NAIC Nair Antunes Instituto do Cancer	Bauru
Brazil	Universidade Estadual De Campinas	Campinas
Brazil	Liga Paranaense de Combate ao Cancer	Curitiba
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Hospital Regional do Cancer - Hospital de Esperança	Presidente Prudente
Brazil	Hospital Sao Rafael	Salvador
Brazil	Hospital Ana Nery Santa Cruz do Sul	Santa Cruz Do Sul
Brazil	CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia	Santo Andre
Brazil	Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo	Sao Paulo
Brazil	Real e Benemérita Associação Portuguesa de Beneficência	Sao Paulo
Brazil	Fundacao Antonio Prudente A C Camargo Cancer Center	São Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	São Paulo
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	St Josephs Healthcare Hamilton	Hamilton	Ontario
Canada	CHUM - Centre hospitalier universitaire de Montreal	Montréal	Quebec
Canada	CHU de Quebec Universite Laval Hopital de l Enfant Jesus	Quebec
Canada	Unite de Recherche Clinique du CISSS des Laurentides	Saint Jerome Quebec	Quebec
Canada	Princess Margaret Cancer Centre University Health Network	Toronto	Ontario
China	Beijing Hospital	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing
China	Peking University First Hospital	Beijing
China	Hunan Province Cancer Hospital	Chang Sha
China	The First Bethune Hospital of Jilin University	Changchun
China	West China Hospital Sichuan University	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	People's Hospital of Deyang City	Deyang City
China	Sun Yat-Sen University Cancer Center	GuangZhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Nanjing Drum Tower Hospital	Nanjing
China	The First Affiliated Hospital of Ningbo University	Ningbo
China	Huadong Hospital Affiliated to Fudan University	Shanghai
China	Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine	Shanghai
China	Shengjing Hospital Of China Medical University	Shenyang
China	The Second Hospital Of Tianjin Medical University	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology	Wuhan
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xian
China	Yantai Yuhuangding Hospital	Yantai
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Králové
Czechia	Krajská nemocnice Liberec a.s.	Liberec
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice v Motole	Prague
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Czechia	Thomayerova nemocnice, Onkologicka klinika	Praha 4
France	Polyclinique Bordeaux Nord Acquitaine	Bordeaux
France	CHU Gabriel-Montpied	Clermont-Ferrand
France	CHU Grenoble	Grenoble
France	Polyclinique de Limoges - Francois Chenieux	Limoges
France	Hôpital Edouard Herriot	Lyon
France	CHU de Nantes hotel Dieu	Nantes
France	CHU Nîmes	Nimes
France	Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source	Orléans
France	APHP - Hopital Bichat - Claude Bernard	Paris
France	Hopital Europeen Georges-Pompidou	Paris
France	Hôpital Universitaire Pitié-Salpêtrière	Paris
France	Groupe Hospitalier Diaconesses Croix Saint Simon	PARIS cedex 20
France	Clinical La Croix Du Sud - Ramsay Santé	Quint-Fonsegrives
France	Chu Rennes Hopital Pontchaillou	Rennes
France	Institut de Cancerologie Strasbourg Europe ICANS	Strasbourg
France	CHU Rangueil	Toulouse
Germany	Urologicum Duisburg	Duisburg
Germany	Universitatsklinikum Erlangen	Erlangen
Germany	Universitatsklinikum Essen	Essen
Germany	Universitaetsklinikum Frankfurt	Frankfurt am Main
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Urologische Partnerschaft Koln UPK	Köln
Germany	Matthias Schulze - Germany	Markkleeberg
Germany	Urologie Neandertal Praxis Mettmann	Mettmann
Germany	Universitatsklinikum Munster	Muenster
Germany	Klinikum rechts der Isar an der Technischen Universitat Munchen	München
Germany	Klinikum Nurnberg Nord	Nuernberg
Germany	Medizinisches Versorgungszentrum - Urologie	Nurnberg
Germany	Studienpraxis Urologie Nurtingen	Nürtingen
Germany	Caritas-Krankenhaus St. Josef	Regensburg
Germany	Universitat Tubingen	Tübingen
India	Health Care Global Enterprises pvt Ltd	Bangalore
India	Post Graduate Institute of Medical Education And Research PGIMER	Chandigarh
India	Artemis Hospital	Gurugram
India	Netaji Subhas chandra Bose Cancer Research Institute	Kolkata
India	Tata Memorial Hospital	Mumbai
India	CIMET s Inamdar Multispeciality Hospital	Pune
Italy	Generale Regionale F. Miulli	Acquaviva delle Fonti
Italy	Ospedale Cardinal Massaia	Asti
Italy	Ospedale San Giuseppe Moscati di Avellino	Avellino
Italy	Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale	Castelfranco Veneto
Italy	Istituto Europeo di Oncologia	Milano
Italy	Ospedale San Raffaele di Milano	Milano
Italy	Fondazione G Pascale Istituto Nazionale Tumori IRCCS	Napoli
Italy	Ospedale S. Maria Delle Croci	Ravenna
Italy	Istituto Nazionale Tumori Regina Elena	Rome
Japan	Fuji City General Hospital	Fuji-shi
Japan	Kanazawa University Hospital	Kanazawa
Japan	Nara Medical University Hospital	Kashihara-shi
Japan	Kimitsu Chuo Hospital	Kisarazu-shi
Japan	Kobe City Medical Center General Hospital	Kobe City
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto-shi
Japan	Nagano Municipal Hospital	Nagano-shi
Japan	JRC Nagasaki Genbaku Hospital	Nagasaki-Shi
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	Saiseikai Narashino Hospital	Narashino-shi
Japan	Ehime University Hospital	Toon-shi
Japan	Toyama University Hospital	Toyama-shi
Japan	Yamaguchi University Hospital	Ube
Japan	Yokohama City University Medical Center	Yokohama
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Mexico	Consultorio Medico dentro del Hospital Angeles Acoxpa	Ciudad de México
Mexico	Eme Red Hospitalaria	Mérida
Mexico	Avix Investigacion Clinica S C	Monterrey
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey
Mexico	Oncologico Potosino	San Luis Potosí
Netherlands	Spaarne Ziekenhuis	Hoofddorp
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboud Umcn	Nijmegen
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	IN VIVO Sp. z o.o	Bydgoszcz
Poland	Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ	Lublin
Poland	Centrum Medyczne	Piotrkow Trybunalski
Poland	Clinical Research Center sp z o o MEDIC R s k	Poznan
Poland	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,	Slupsk
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	Warszawa
Poland	Provita Poliklinika	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Portugal	Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE	Coimbra
Portugal	Centro Hospitalar de Lisboa Norte Hospital Santa Maria	Lisboa
Portugal	Centro Hospitalar de Vila Nova de Gaia Espinho E P E	Vila Nova de Gaia
Spain	Hosp. Univ. A Coruna	A Coruña
Spain	Hosp. Punta de Europa	Algeciras
Spain	Fund. Puigvert	Barcelona
Spain	Hosp. Puerta Del Mar	Cádiz
Spain	Hosp. Gral. Univ. de Castellon	Castellon
Spain	Hosp. Univ. de Bellvitge	L'Hospitalet de Llobregat
Spain	Hosp. Univ. Lucus Augusti	Lugo
Spain	Clinica Univ. de Navarra	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. Virgen de La Victoria	Málaga
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Clinico Univ. de Valencia	Valencia
Taiwan	Chang Kung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Charing Cross Hospital	London
United Kingdom	St Bartholomews Hospital	London
United Kingdom	The Royal Marsden NHS Trust	London
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Scunthorpe General Hospital	Scunthorpe
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital	Truro
United States	University of Michigan	Ann Arbor	Michigan
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	The Emory Clinic Department of Urology	Atlanta	Georgia
United States	Urology Austin	Austin	Texas
United States	Centers for Advanced Urology LLC d b a MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	Cooper Health System MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	Urology of Indiana	Carmel	Indiana
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Central Ohio Urology Group	Gahanna	Ohio
United States	Vidant Urology - Greenville	Greenville	North Carolina
United States	Chesapeake Urology Research Associates	Hanover	Maryland
United States	Urological Research Network	Hialeah	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	Houston Metro Urology	Houston	Texas
United States	First Urology	Jeffersonville	Indiana
United States	Colorado Clinical Research	Lakewood	Colorado
United States	Duly Health and Care	Lisle	Illinois
United States	Arkansas Urology	Little Rock	Arkansas
United States	VA Long Beach Health Care System	Long Beach	California
United States	Genesis Research, LLC - West Coast Urology	Los Alamitos	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	AMR Kansas City Oncology	Merriam	Kansas
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	VA NY Harbor Healthcare System	New York	New York
United States	The Urology Center, PC	Omaha	Nebraska
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania
United States	Blessing Hospital	Quincy	Illinois
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	George E. Wahlen VAMC	Salt Lake City	Utah
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Urology San Antonio Research	San Antonio	Texas
United States	Genesis Research	San Diego	California
United States	Providence Saint Johns Cancer Institute	Santa Monica	California
United States	Providence Medical Foundation	Santa Rosa	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Mayo Clinic	Scottsdale	Arizona
United States	Spokane Urology	Spokane	Washington
United States	Associated Medical Professionals of Ny	Syracuse	New York
United States	SUNY Upstate Med Univ	Syracuse	New York
United States	Urology Of Virginia, Pllc	Virginia Beach	Virginia
United States	Wichita Urology Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival (EFS)	EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.	Up to 5 years 2 months
Secondary	Overall Complete Response (CR) Rate	Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.	Up to 5 years 2 months
Secondary	Duration of CR	Duration of CR is defined from the time of first CR achieved to first evidence of recurrence, progression or death due to any cause (whichever occurs first) for participants who achieve a CR.	Up to 5 years 2 months
Secondary	Recurrence-Free Survival (RFS)	RFS is defined as the time from randomization to the time of the first recurrence of high-risk disease, or death due to any cause, whichever occurs first.	Up to 5 years 2 months
Secondary	Time to Progression (TTP)	TTP is defined as the time from randomization to the date of first documented evidence of disease progression or death due to disease progression, whichever occurs first.	Up to 5 years 2 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death, due to any cause.	Up to 5 years 2 months
Secondary	Cancer Specific Survival (CSS)	CSS is defined as the time from randomization to the date of death due to bladder cancer.	Up to 5 years 2 months
Secondary	Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)	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 5 years 2 months
Secondary	Number of Participants with Adverse Events (AEs)	Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.	Up to 5 years 2 months
Secondary	Number of Participants with Change from Baseline in Laboratory Abnormalities	Number of participants with change from baseline in laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe, Grade 4- Life-threatening, and Grade 5- Death related to adverse event.	Up to 5 years 2 months
Secondary	Number of Participants with Change from Baseline in Vital Signs Abnormalities	Number of participants with change from baseline in vital signs (blood pressure [systolic and diastolic], heart rate, temperature, and weight) abnormalities will be reported.	Up to 5 years 2 months
Secondary	Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24	EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the Health-related quality of life (HRQoL) of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the quality of life questionnaire (QLQ-C30) and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).	Up to 5 years 2 months
Secondary	Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores	EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).	Up to 5 years 2 months