A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Urinary Bladder Neoplasms Clinical Trial

— SunRISe-2  

Official title:

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658862
• Other study ID #: CR108917
• Secondary ID: 2020-002620-3617
• Status: Recruiting
• Phase: Phase 3
• Start date: December 7, 2020
• Est. completion date: December 26, 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 study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 26, 2029
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ineligible for or have elected not to undergo radical cystectomy

• 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 randomization

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

• Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results

• Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (>=) 1,500/cubic millimeters (mm^3); Platelet count >=80,000/mm^3; Hemoglobin >=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal function: Creatinine clearance >=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function

Exclusion Criteria:

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

• Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT

• Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization

• 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

• Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms

Intervention

Biological:
• Cetrelimab
Participants will receive intravenous Cetrelimab.

Drug:
• TAR-200
Participants will receive intravesical TAR-200.
• Cisplatin
Participants will receive cisplatin intravenously.
• Gemcitabine
Participants will receive gemcitabine intravenously.

Radiation:
• Conventional radiation therapy
Participants will receive conventional radiation therapy for bladder (64 gy).
• Hypo-fractioned radiation therapy
Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).

Locations

Country	Name	City	State
Argentina	Fundacion Intecnus	Bariloche
Argentina	Instituto Medico Especializado Alexander Fleming	Buenos Aires
Argentina	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	Buenos Aires
Argentina	Centro de Urologia (CDU)	Ciudad Automoma Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica	Córdoba
Argentina	Centro Urologico Profesor Bengio	Córdoba
Argentina	Sanatorio Allende Cerro	Córdoba
Argentina	Centro Oncologico Riojano Integral (Cori)	La Rioja
Argentina	Centro de Investigacion Pergamino SA	Pergamino
Argentina	CEDIC Centro de Investigaciones Clinicas	Viedma
Australia	Flinders Medical Centre	Bedford Park
Austria	Krankenhaus der barmherzigen Schwestern	Linz
Austria	Universitaetsklinikum Salzburg Landeskrankenhaus	Salzburg
Austria	Medizinische Universitat Wien	Wien
Belgium	Hopital Erasme	Anderlecht
Belgium	ZNA Middelheim	Antwerpen
Belgium	AZ Sint-Lucas	Assebroek
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge
Belgium	Az Groeninge	Kortrijk
Belgium	Algemeen Ziekenhuis Delta	Roeselare
Brazil	Fundacao Pio XII	Barretos
Brazil	Fundação Hospitalar São Francisco de Assis	Belo Horizonte
Brazil	Liga Paranaense de Combate ao Cancer	Curitiba
Brazil	Centro Regional Integrado de Oncologia CRIO	Fortaleza
Brazil	Clinica de Oncologia Reichow	Jardim Blumenau
Brazil	Fundacao Doutor Amaral Carvalho	Jau
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital Moinhos de Vento	Porto Alegre
Brazil	Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS	Porto Alegre
Brazil	Hospital Regional do Cancer - Hospital de Esperança	Presidente Prudente
Brazil	Hospital Sao Rafael	Salvador
Brazil	CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia	Santo André
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base	Sao Jose do Rio Preto
Brazil	Ac Camargo Cancer Center	Sao Paulo
Brazil	Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo	Sao Paulo
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo
Brazil	Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE	Sao Paulo
Brazil	Sociedade Beneficente de Senhoras - Hospital Sirio Libanes	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	São Paulo
Brazil	Centro Oncológico do Triângulo	Uberlândia
Canada	McGill University Health Centre	Montreal	Quebec
Canada	CHU de Quebec L Hotel Dieu de Quebec	Québec	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
China	Beijing Hospital	Beijing
China	Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	The Third Xiangya Hospital of Central Sourth University	Changsha
China	Hunan Cancer hospital	Changsha Shi
China	West China Hospital of Sichuan University	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	Guangzhou First Municipal People's Hospital	Guang Zhou Shi
China	Sun Yat-Sen University Cancer Center	Guangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	The First Hospital of Jiaxing	Jiaxing
China	Nanjing Drum Tower Hospital	Nanjing
China	Qingdao Municipal Hospital	Qingdao
China	Renji Hospital	Shanghai
China	Ruijin Hospital	Shanghai
China	Shengjing Hospital Of China Medical University	Shenyang
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou Shi
China	Wuhan Tongji Hospital Tongji Medical College	Wuhan
China	Wuhan Union Hospital	Wuhan
China	Yantai Yuhuangding Hospital	Yantai
China	Henan Cancer Hospital	Zhengzhou
Czechia	Slezska nemocnice v Opave	Opava
Czechia	Fakultni nemocnice Plze	Plzen-Bory
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Czechia	Urocentrum Praha	Praha 2
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Thomayerova nemocnice	Praha 4
Czechia	Fakultni nemocnice v Motole	Praha 5
Czechia	Nemocnice Na Bulovce	Praha 8
France	Hopital Pellegrin CHU Bordeaux	Bordeaux
France	ICH Hopital A. Morvan	Brest
France	Hôpital Côte de Nacre	Caen Cedex 9
France	Pole Sante Leonard de Vinci	Chambray-lès-Tours
France	Clinique Sainte Marguerite	Hyeres
France	CHRU Lille	Lille
France	Polyclinique de Limoges - Francois Chenieux	Limoges
France	Hôpital Edouard Herriot	Lyon Cedex 03
France	Hôpital Européen	Marseille
France	Institut Paoli-Calmettes	Marseille
France	Institut Regional du Cancer de Montpellier	Montpellier
France	CHU Nîmes	Nimes
France	Hôpital Bichat - Claude Bernard	Paris
France	Hopital Europeen Georges-Pompidou	Paris
France	Hopital Tenon	Paris
France	Institut Mutualiste Montsouris	Paris
France	Clinical La Croix Du Sud - Ramsay Santé	Quint-Fonsegrives
France	Centre hospitalier universitaire de St Etienne	Saint-Etienne Cedex 2
France	Centre Hospitalier Prive	Saint-Grégoire
France	Hopital Foch	Suresnes
France	Institut de Cancérologie de Lorraine	Vandoeuvre-les-Nancy
France	Gustave Roussy	Villejuif Cedex
Germany	Staedtisches Klinikum Braunschweig	Braunschweig
Germany	Universitatsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düesseldorf
Germany	Urologicum Duisburg	Duisburg
Germany	Klinik und Poliklinik für Urologie	Essen
Germany	Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus	Frankfurt Am Main
Germany	Universitatsklinikum Frankfurt	Frankfurt am Main
Germany	SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen	Heilbronn
Germany	Klinikum Herne - Urologie	Herne
Germany	Matthias Schulze - Germany	Markkleeberg
Germany	Universitatsklinikum Munster	Münster
Germany	Klinikum Nürnberg Nord - Hautklinik	Nürnberg
Germany	Krankenhaus der Barmherzigen Bruder Trier	Trier
Greece	Alexandra General Hospital of Athens	Athens
Greece	Metropolitan General A E	Holargos
Greece	Athens Medical Center	Maroussi
Greece	Metropolitan Hospital	Neo Faliro
Greece	Bioclinic - Thessaloniki	Thessaloniki
Greece	Clinic Agios Loukas	Thessaloniki
Greece	Euromedica General Clinic	Thessaloniki
Greece	Papageorgiou General Hospital Of Thessaloniki	Thessaloniki
Greece	Anassa General Clinic	Volos
Hungary	Bajcsy-Zsilinszky Kórház és Rendelointézet	Budapest
Hungary	Eszak Pesti Centrumkorhaz Honvedkorhaz	Budapest
Hungary	Orszagos Onkologiai Intezet	Budapest N/a
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz	Nyíregyháza
India	Sujan Surgical Cancer Hospital & Amravati Cancer Foundation	Amravati
India	Bangalore Medical College and Research Institute	Bangalore
India	Acharya Tulsi Regional Cancer Treatment Research Institute	Bikaner
India	Shatabdi Super Speciality Hospital	Nashik
India	Aakash Healthcare Super Speciality Hospital	New Delhi
India	BLK Super Specialty Hospital	New Delhi
India	Rajiv Gandhi Cancer Institute & Research Centre	New Delhi
India	Indira Gandhi Institute of Medical Sciences	Patna
India	Jehangir Clinical Development Center Pvt Ltd	Pune
Italy	Ospedale San Donato	Arezzo
Italy	Fondazione del Piemonte per I Oncologia IRCC Candiolo	Candiolo
Italy	Ospedale Civile Ramazzini	Carpi
Italy	Ospedale Cannizzaro	Catania
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia	Foggia
Italy	Ospedale San Martino	Genova
Italy	SPDC Villa Scassi	Genova
Italy	Ospedale Umberto I di Lugo	Lugo
Italy	Ospedale San Raffaele	Milan
Italy	Istituto Europeo di Oncologia	Milano
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Istituto Oncologico Veneto - IRCCS	Padova
Italy	Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani	Pagani
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	ASL Napoli 2 Nord-SM delle Grazie Hospital	Pozzuoli
Italy	Azienda Ospedaliera Sant Andrea	Roma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Istituto Nazionale Tumori Regina Elena	Rome
Italy	Universita Campus Bio-Medico di Roma	Rome
Italy	Istituto Clinico Humanitas Rozzano, IRCCS	Rozzano
Italy	Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte	Siena
Italy	Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino	Torino
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Italy	Ospedale San Bortolo	Vicenza
Japan	Aso Co.,Ltd Iizuka Hospital	Iizuka
Japan	St Marianna University Hospital	Kanagawa
Japan	Nara Medical University Hospital	Kashihara
Japan	Saitama Medical University Hospital	Kawagoe-Shi
Japan	Kimitsu Chuo Hospital	Kisarazu-shi
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	JOHAS Osaka Rosai Hospital	Osaka
Japan	Tokuyama Central Hospital	Shunan
Japan	Nippon Medical School Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Japan	Fujita Health University Hospital	Toyoake
Japan	Yamaguchi University Hospital	Ube
Japan	Yokohama City University Medical Center	Yokohama
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Samsung Medical Center	Gangnam Gu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun
Korea, Republic of	Gachon University Gil Medical Center	Namdong
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St Mary s Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan Si
Mexico	Oncologia Integral Satelite	Ciudad de México
Mexico	Consultorio Privado Dr Jose Arturo Rodriguez Rivera	Guadalajara
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
Mexico	Centro De Estudio Y Prevencion Del Cancer	Juchitan De Zaragoza
Mexico	Dr. Marco Antonio Badillo Santoyo	Leon
Mexico	i Can Oncology Center	Monterrey
Mexico	Centro de Investigacion Clinica Chapultepec	Morelia
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Mexico	Oncologico Potosino	San Luis Potosi
Mexico	Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.	Zapopan
Poland	Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II	Siedlce
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa
Poland	Uniwersytecki Szpital Kliniczny	Wroclaw
Portugal	Hospital Garcia de Orta	Almada
Portugal	Centro Hospitalar e Universitario de Coimbra	Coimbra
Portugal	Centro Hospitalar de Lisboa Central	Lisboa
Portugal	H. Santa Maria - Centro Hospitalar de Lisboa Norte	Lisboa
Portugal	Fund. Champalimaud	Lisbon
Portugal	Hospital de Sao Joao	Porto
Russian Federation	Altlay Regional Oncology Dispensary	Barnaul
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	Krasnoyarsk Regional Oncology Dispensary	Krasnoyarsk
Russian Federation	Hertzen Oncology Research Institute	Moscow
Russian Federation	A. Tsyb Medical Radiological Research Center	Obninsk
Russian Federation	BHI of Omsk region Clinical Oncology Dispensary	Omsk
Russian Federation	Ryazan State Medical University named after I.P.Pavlov	Ryazan
Russian Federation	N.N. Petrov Research Institute Of Oncology	Saint Petersburg
Russian Federation	Ogarev Mordovian State University	Saransk
Russian Federation	State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio	Sochi
Russian Federation	Multifunctional clinical medical center 'Medical city'	Tyumen
Russian Federation	Bashkir State Medical University	Ufa
Spain	Hosp. Univ. A Coruna	A Coruña
Spain	Hosp. Univ. Germans Trias I Pujol	Badalona
Spain	Fund. Puigvert	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. Virgen de Las Nieves	Granada
Spain	Hosp. de Jerez de La Frontera	Jerez de la Frontera
Spain	Clinica Univ. de Navarra	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. de La Paz	Madrid
Spain	Hosp. Univ. Hm Sanchinarro	Madrid
Spain	Corporacio Sanitari Parc Tauli	Sabadell
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Clinico Univ. de Valencia	Valencia
Spain	Instituto Valenciano de Oncologia	Valencia
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital Linkou Branch	Taoyuan
Turkey	Adana Baskent Yuregir Hospital	Adana
Turkey	Ankara Universitesi Tip Fakultesi Cebeci Hastanesi	Ankara
Turkey	Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital	Ankara
Turkey	Dokuz Eylul Universitesi Tip Fakultesi	Balcova
Turkey	Bezmialem University Medical Faculty	Fatih
Turkey	Medical Park Gaziantep Hastanesi	Gaziantep
Turkey	Istanbul Medeniyet University Goztepe Training and Research Hospital	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Izmir Medical Park Hospital	Izmir
Turkey	Inonu University Medical Faculty	Malatya
Turkey	Erciyes Univ MKD Hospital	Melikgazi
Turkey	T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi	Seyhan
Ukraine	Chernihivskyi oblasnyi onkolohichnyi dyspanser	Chernihiv
Ukraine	SE Dnipropetrovsk Medical Academy	Dnipro
Ukraine	Kharkiv Regional Clinical Hospital	Kharkiv
Ukraine	Khersonsky Regional Oncology Center	Kherson
Ukraine	Asklepion LLC	Kiev
Ukraine	Kyiv City Clinical Hospital #3	Kyiv
Ukraine	P.L. Shupyk National Medical Academy of Post-Graduate Education	Kyiv
Ukraine	State Institution Academy Of Medical Sciences Of Ukraine	Kyiv
Ukraine	Lviv Regional Clinical Hospital	Lviv
United States	University Hospitals Seidman Cancer Center	Ann Arbor	Michigan
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Cardiology Clinic at Montefiore Hutchinson Complex	Bronx	New York
United States	Wexner Medical Center at the Ohio State University	Columbus	Ohio
United States	The Urology Center of Colorado	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Foothills Urology - Golden Off	Golden	Colorado
United States	Vidant Urology - Greenville	Greenville	North Carolina
United States	Urological Research Network	Hialeah	Florida
United States	Houston Metro Urology	Houston	Texas
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of Texas Medical Branch	League City	Texas
United States	DuPage Medical Group	Lisle	Illinois
United States	Loma Linda Univ Faculty Medic	Loma Linda	California
United States	University of Southern California	Los Angeles	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Adult Pediatric Urology & Urogynecology, P.C	Omaha	Nebraska
United States	Memorial Healthcare System	Pembroke Pines	Florida
United States	Providence Saint John s Health Center	Santa Monica	California
United States	Stanford University Medical Center	Stanford	California
United States	Michigan Institute of Urology	Troy	Michigan
United States	New Jersey Urology LLC	Voorhees	New Jersey
United States	Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event	Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.	Up to 8 years
Secondary	Metastasis-free survival (MFS)	MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) evidence of metastatic disease or death due to any cause.	Up to 8 years
Secondary	Overall Survival (OS)	OS is defined as time from randomization to death.	Up to 8 years
Secondary	Overall Response Rate (ORR)	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). CR is defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging (CT/MRI) showing no evidence of locally advanced or metastatic disease. PR (down-staging) is defined as biopsy proven non-muscle invasive disease (Ta, T1, Tis) and CT/MRI showing no evidence of locally advanced or metastatic disease. Non-Response (NR) includes those not achieving a CR or PR. Those who do not undergo a biopsy will be considered Non-Evaluable (NE).	Up to 8 years
Secondary	Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)	Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.	Up to 8 years
Secondary	Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)	NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.	Up to 8 years
Secondary	Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical 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 8 years