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NCT04209114
Recruiting
December 23, 2019
March 21, 2022
Brief summary:
The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.
N/A
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: Combination Therapy Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg |
Biological: Nivolumab Specified dose on specified days Biological: Bempegaldesleukin Specified dose on specified days Procedure: Radical cystectomy (RC) Surgical removal of the bladder |
| Experimental: Arm B: Monotherapy Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab |
Biological: Nivolumab Specified dose on specified days Procedure: Radical cystectomy (RC) Surgical removal of the bladder |
| Other: Arm C: Standard-of-care RC alone, without neoadjuvant or adjuvant therapy |
Procedure: Radical cystectomy (RC) Surgical removal of the bladder |
Inclusion Criteria: Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT) Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Cisplatin-ineligible participants will be defined by any one of the following criteria: i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing loss (assessed per local SOC). iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy. Documented Left Ventricular Ejection Fraction (LVEF) more than 45% Exclusion Criteria: Clinical evidence of ≥ N2 or metastatic bladder cancer Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment. Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias) Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Alabama
Local Institution
Birmingham
United States, Alabama
Local Institution
Mobile
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert
United States, Arizona
Arizona Cancer Center
Tucson
United States, California
UC San Diego Moores Cancer Ctr
La Jolla
United States, California
Uc Irvine Health
Orange
United States, Florida
Local Institution
Miami
United States, Florida
Local Institution
Pensacola
United States, Georgia
Local Institution
Atlanta
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City
United States, Louisiana
Local Institution
New Orleans
United States, Maine
Local Institution
Scarborough
United States, Minnesota
Local Institution
Rochester
United States, Missouri
Local Institution
Saint Louis
United States, New Jersey
Local Institution
Belleville
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
United States, New York
Montefiore Medical Center
Bronx
United States, New York
Roswell Park Cancer Institute
Buffalo
United States, New York
Local Institution
Johnson City
United States, New York
Local Institution
Lake Success
United States, New York
Local Institution
New York
United States, New York
Local Institution
New York
United States, North Carolina
Duke University
Durham
United States, Oregon
Local Institution
Eugene
United States, Pennsylvania
Lehigh Valley Health Network
Allentown
United States, Pennsylvania
Local Institution
Hershey
United States, South Carolina
Medical University Of South Carolina
Charleston
United States, Tennessee
Local Institution
Chattanooga
United States, Texas
The University Of Texas MD Anderson Cancer Center
Houston
United States, Texas
Local Institution
San Antonio
United States, Texas
Scott And White Memorial Hosp
Temple
United States, Washington
University of Washington - Seattle Cancer Care Alliance
Seattle
United States, Washington
Local Institution
Spokane Valley
United States, Washington
Northwest Medical Specialties, Pllc
Tacoma
Argentina, Buenos Aires
Instituto Alexander Fleming
Caba
Argentina, Buenos Aires
Hospital Sirio Libanes
Capital Federal
Argentina, Buenos Aires
Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires
Argentina, Buenos Aires
Hospital Italiano De La Plata
La Plata
Argentina, Distrito Federal
Local Institution
Caba
Argentina, Santa FE
Local Institution
Rosario
Argentina
Instituto Oncologico De Cordoba
Cordoba
Australia, New South Wales
Gosford Hospital
Gosford
Australia, Victoria
Ballarat Health Services
Ballarat
Australia, Victoria
St Vincent's Hospital
Fitzroy
Australia, Victoria
Austin Hospital
Heidelberg
Australia, Western Australia
St John of God Murdoch Hospital
Murdoch
Austria
Universitaetsklinikum Graz
Graz
Austria
Medizinische Universitaet Wien
Wien
Austria
Klinik Ottakring (früher: Wilhelminenspital)
Wien
Belgium
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Brussel
Belgium
Local Institution
Charleroi
Belgium
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Edegem
Belgium
Local Institution
Gent
Belgium
Local Institution
Liège
Belgium
Local Institution
Wilrijk
Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre
Brazil, RIO Grande DO SUL
Hospital Nossa Senhora Da Conceição
Porto Alegre
Brazil, SAO Paulo
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica
Barretos
Brazil, Sao Paulo
Fundacao Doutor Amaral Carvalho
Jau
Brazil
Inca - Instituto Nacional Do Cancer
Rio De Janeiro
Brazil
Hospital Sirio Libanes
Sao Paulo
Brazil
A. C. Camargo Cancer Center
Sao Paulo
Brazil
Local Institution
Sao Paulo
Canada, Alberta
Cross Cancer Institute
Edmonton
Canada, British Columbia
Local Institution
Surrey
Canada, Ontario
Lakeridge Health Oshawa-Durham Regional Cancer Centre
Oshawa
Canada, Quebec
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Montreal
Canada, Quebec
Local Institution
Sherbrooke
Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec
China, Beijing
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Beijing
China, Beijing
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Beijing
China, Chongqing
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Chongqing
China, Fujian
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Fuzhou
China, Fujian
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Xiamen
China, Guangdong
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Guangzhou
China, Guangdong
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Guangzhou
China, Heilongjiang
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Harbin
China, Henan
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Zhengzhou
China, Hubei
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Wuhan
China, Hunan
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Changsha
China, Jiangsu
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Nanjing
China, Jiangxi
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Nanchang
China, Shan1xi
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Taiyuan
China, Shan3xi
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XI An
China, Shandong
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Jinan
China, Shanghai
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Shanghai
China, Shanghai
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Shanghai
China, Shanghai
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Shanghai
China, Sichuan
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Chengdu
China, Tianjin
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Tianjin
China, Zhejiang
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Hangzhou
China, Zhejiang
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Wenzhou
Czechia
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Olomouc
Czechia
Local Institution
Praha 4
Czechia
Urologicka klinika 2. LF UK a FN Motol
Praha 5
France
Institut Sainte Catherine
Avignon Cedex 9
France
Hopital Saint Andre
Bordeaux
France
Centre Hospitalier de Cornouaille - Hopital Laennec
Brest
France
Local Institution
Caen
France
Centre Jean Perrin
Clermont-ferrand
France
Ch Departemental de Vendee
La Roche-sur-yon Cedex 9
France
Centre Leon Berard
Lyon Cedex 08
France
Institut Paoli-Calmettes
Marseille Cedex 9
France
Institut du Cancer de Montpellier
Montpellier
France
Centre Antoine Lacassagne
Nice
France
Institut Mutualiste Montsouris
Paris
France
Hopital Europeen Georges Pompidou
Paris
France
Institut Jean Godinot-Clinical Research Unit
Reims
France
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Rennes Cedex
France
ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg
France
Hopital Foch
Suresnes
France
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Toulouse Cedex 9
France
Hopital Bretonneau
Tours
France
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Valenciennes
Germany
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Chemnitz
Germany
Universitatsklinikum Carl Gustav Carus
Dresden
Germany
Uniklinikum Duesseldorf
Duesseldorf
Germany
Universitaetsklinikum Erlangen
Erlangen
Germany
Universitaetsklinikum Essen
Essen
Germany
Universitaetsklinikum Hamburg
Hamburg
Germany
Asklepios Klinik Altona
Hamburg
Germany
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Hannover
Germany
Marien Hospital Herne
Herne
Germany
Universitaetsklinikum Jena
Jena
Germany
University Hospital Schleswig-Holstein
Luebeck
Germany
Universitaetsklinikum Muenster
Muenster
Germany
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg
Germany
Uniklinik Tuebingen
Tuebingen
Greece
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Athens
Greece
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Athens
Greece
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Marousi
Greece
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Thessaloniki
Israel
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Haifa
Israel
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Ramat Gan
Israel
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Tel-aviv
Italy
A.O.U. Careggi
Firenze
Italy
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Milano
Italy
IRCCS Istituto Nazionale Tumori Milano
Milano
Italy
Local Institution
Pavia
Italy
Azienda Ospedaliera Universitaria Pisana
Pisa
Italy
Policlinico Gemelli
Roma
Italy
Istituto Clinico Humanitas IRCCS
Rozzano
Mexico, BAJA Californa SUR
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La Paz
Mexico, Distrito Federal
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Ciudad de Mexico
Mexico, Distrito Federal
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Mexico
Mexico, Distrito Federal
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Mexico
Mexico, Distrito Federal
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Mexico
Mexico, Nuevo LEON
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Monterey
Netherlands
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Amsterdam
New Zealand
Local Institution
Auckland
Poland
KO-MED Biala Podlaska-Oddział Onkologii Klinicznej i Hematologii
Biala Podlaska
Poland
Local Institution
Katowice
Poland
Local Institution
Poznan
Poland
Klinika Nowotworow Ukladu Moczowego
Warszawa
Poland
Local Institution
Wroclaw
Russian Federation
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Omsk
Russian Federation
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Saint-Petersburg
Spain
Comp. Hosp. Univ. A Coruna
A Coruña
Spain
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona
Spain
H. Univ. Vall dHebron
Barcelona
Spain
Hospital Universitario Reina Sofia
Cordoba
Spain
Hospital General Universitario Gregorio Maranon
Madrid
Spain
Hospital Universitario Ramon Y Cajal
Madrid
Spain
Hosp Univer 12 De Octubre
Madrid
Spain
H. U. Marques de Valdecilla
Santander
Spain
Hospital Universitario Virgen Del Rocio
Sevilla
Turkey, Bornova
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Izmir
Turkey
Local Institution
Adana
Turkey
Local Institution
Ankara
Turkey
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Ankara
Turkey
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Antalya
Turkey
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Istanbul
Turkey
Local Institution
Istanbul
Turkey
Local Institution
Istanbul
Turkey
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Istanbul
Turkey
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Izmir
United Kingdom, Hertfordshire
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Stevenage
United Kingdom
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Bebington
United Kingdom
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Leicester
United Kingdom
Local Institution
London
United Kingdom
Local Institution
London
United Kingdom
Local Institution
London
United Kingdom
Local Institution
Wolverhampton
Bristol-Myers Squibb
Nektar Therapeutics
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb