Bladder Cancer Clinical Trial
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Summary
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
Must have disease free status as determined by imaging within 4 weeks of dosing
Tumor tissue must be provided for biomarker analysis
Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
Exclusion Criteria:
Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
Subjects with active, known or suspected autoimmune disease
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
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There are 180 Locations for this study
Anchorage Alaska, 99503, United States
Tucson Arizona, 85704, United States
Clovis California, 93611, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Lakewood Colorado, 80228, United States
Gainesville Florida, 32610, United States
Miami Beach Florida, 33140, United States
Tampa Florida, 33612, United States
Maywood Illinois, 60153, United States
Fort Wayne Indiana, 46804, United States
New Orleans Louisiana, 70112, United States
Grand Rapids Michigan, 49503, United States
Burnsville Minnesota, 55337, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89148, United States
Albany New York, 12208, United States
Buffalo New York, 14263, United States
Mineola New York, 11501, United States
New York New York, 10021, United States
New York New York, 10029, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27708, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Tigard Oregon, 97223, United States
Allentown Pennsylvania, 18103, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Myrtle Beach South Carolina, 29572, United States
Chattanooga Tennessee, 37404, United States
Norfolk Virginia, 23502, United States
Berazategui Buenos Aires, 1880, Argentina
Capital Federal Buenos Aires, 1426, Argentina
Ciudad Autonoma De Buenos Aire Buenos Aires, 1181, Argentina
Ciudad Autónoma de BuenosAires Buenos Aires, C1280, Argentina
Viedma RIO Negro, 8500, Argentina
San Miguel De Tucuman Tucuman, 4000, Argentina
Liverpool New South Wales, 2170, Australia
St. Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Elizabeth Vale South Australia, 5112, Australia
Frankston Victoria, 3199, Australia
Perth Western Australia, 6150, Australia
Linz , 4010, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Wien , 1090, Austria
Hasselt , 3500, Belgium
Liege , 4000, Belgium
Ijui RIO Grande DO SUL, 98700, Brazil
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Barretos Sao Paulo, 14780, Brazil
Cerqueira Cesar SAO Paulo, 01246, Brazil
Rio De Janeiro , 20231, Brazil
São Paulo , 04014, Brazil
Edmonton Alberta, T6G 1, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Montreal , H2X 0, Canada
Santiago Metropolitana, , Chile
Vina Del Mar Valparaiso, 25403, Chile
Temuco , 48102, Chile
Beijing Beijing, 10000, China
Beijing Beijing, 10003, China
Beijing Beijing, 10005, China
Chongqing Chongqing, 40003, China
Fuzhou Fujian, 35000, China
Guangzhou Guangdong, 51023, China
Guangzhou Guangdong, 51028, China
Nanning Guangxi, 53002, China
Wuhan Hubei, 43003, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21002, China
Nanchang Jiangxi, 33000, China
Xi'an Shan3xi, 71006, China
Yantai Shandong, 26400, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20004, China
Shanghai Shanghai, 20004, China
Chengdu Sichuan, 61004, China
Chengdu Sichuan, 61007, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Wenzhou Zhejiang, 32500, China
Bogota , 0, Colombia
Floridablanca , 68100, Colombia
Medellin , 05003, Colombia
Aalborg , 9100, Denmark
Aarhus N , 8200, Denmark
Copenhagen , 2100, Denmark
Clermont-ferrand , 63000, France
La Roche-sur-Yon , 85000, France
Marseille Cedex 9 , 13273, France
Paris , 75475, France
Strasbourg , 67200, France
Suresnes , 92151, France
Villejuif , 94800, France
Chemnitz , 09130, Germany
Essen , 45136, Germany
Greifswald , 17475, Germany
Hamburg , 20246, Germany
Heidelberg , 69126, Germany
Jena , 07747, Germany
Marburg , 35043, Germany
Muenster , 48149, Germany
Munich , 81675, Germany
Nuernberg , 90419, Germany
Regensburg , 93053, Germany
Stuttgart , 70174, Germany
Athens , 11528, Greece
Thessaloniki , 54007, Greece
Wilton Cork, 0, Ireland
Dublin , , Ireland
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52621, Israel
Zerifin , 70300, Israel
Arezzo , 52100, Italy
Bergamo , 24127, Italy
Milano , 20133, Italy
Pisa , 56126, Italy
Reggio Emilia , 42100, Italy
Roma , 00144, Italy
Roma , 00152, Italy
Siena , 53100, Italy
Akita-shi Akita, 01085, Japan
Hirosaki Aomori, 03685, Japan
Fukuoka-shi Fukuoka, 81285, Japan
Sapporo-shi Hokkaido, 06086, Japan
Sapporo Hokkaido, 060-8, Japan
Tsukuba-shi Ibaraki, 30585, Japan
Nagasaki-shi Nagasaki, 85285, Japan
Niigata-shi Niigata, 95185, Japan
Okayama-city Okayama, 700-8, Japan
Osakasayama Osaka, 589-8, Japan
Hamamatasu Shizuoka, 431-3, Japan
Bunkyo-ku Tokyo, 11386, Japan
Shinjuku-Ku Tokyo, 16085, Japan
Shinjuku-ku Tokyo, 16286, Japan
Chiba , 260-8, Japan
Osaka , 54185, Japan
Seongnam-si , 13620, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Df Distrito Federal, 06720, Mexico
Mexico City Distrito Federal, 14080, Mexico
Mexico Distrito Federal, 06700, Mexico
Mexico Distrito Federal, 14080, Mexico
Guadalajara Jalisco, 44270, Mexico
Monterrey Nuevo Leon, 64460, Mexico
Amsterdam , 1105 , Netherlands
Maastrict , 6229 , Netherlands
Nijmegen , 6525 , Netherlands
Lima , Lima , Peru
Gdansk , 80-21, Poland
Lodz , 93-51, Poland
Warsaw , 02-79, Poland
Wroclaw , 50-55, Poland
Wroclaw , 53-41, Poland
Bucuresti , 02138, Romania
Craiova , 20034, Romania
Floresti , 40728, Romania
Timisoara, Timis , 30023, Romania
Moscow , 12528, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Badalona-barcelona , 08916, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Lund , 221 8, Sweden
Basel , 4031, Switzerland
Zuerich , 8038, Switzerland
Kaohsiung , 807, Taiwan
Taichung , 404, Taiwan
Taipei , 100, Taiwan
Manchester Greater Manchester, M20 4, United Kingdom
Edinburgh Midlothian, EH4 2, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Sheffield Yorkshire, S10 2, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
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