Kidney Cancer Clinical Trial
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
Summary
The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
Full Description
The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).
Eligibility Criteria
Inclusion Criteria:
Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Women must agree to follow methods of contraception, if applicable
Exclusion Criteria:
Participants with an active known or suspected autoimmune disease
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
History of allergy or hypersensitivity to study drug components
Participants with a condition requiring systemic treatment with corticosteroids
Participants who have received a live/attenuated vaccine within 30 days of first treatment
Other protocol-defined inclusion/exclusion criteria apply
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There are 188 Locations for this study
Birmingham Alabama, 35205, United States
Springdale Arkansas, 72762, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Aurora Colorado, 80045, United States
Athens Georgia, 30607, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Saint Louis Missouri, 63110, United States
Howell New Jersey, 07731, United States
Buffalo New York, 14263, United States
New York New York, 10029, United States
New York New York, 10065, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18103, United States
Greenville South Carolina, 29607, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37232, United States
Fairfax Virginia, 22031, United States
Capital Federal Buenos Aires, 1280, Argentina
Ciudad Autonoma de Buenos Aires Buenos Aires, 1425, Argentina
Ciudad Autónoma De Buenos Aires Buenos Aires, 1426, Argentina
Mar Del Plata Buenos Aires, 7600, Argentina
Mar Del Plata Buenos Aires, B7600, Argentina
Rio Cuarto Cordoba, 5800, Argentina
Bariloche RIO Negro, 0, Argentina
Buenos Aires , C1419, Argentina
Caba , 1199, Argentina
Cordoba , 5000, Argentina
Cordoba , X5004, Argentina
San Juan , 5402, Argentina
Tucuman , 4000, Argentina
Macquarie Park New South Wales, 2109, Australia
Northmead New South Wales, 2152, Australia
Randwick New South Wales, 2031, Australia
St Leonards New South Wales, 2065, Australia
South Brisbane Queensland, 4101, Australia
Southport Queensland, 4215, Australia
Elizabeth Vale South Australia, 5112, Australia
Clayton Victoria, 0, Australia
Heidelberg Victoria, 3084, Australia
Murdoch Western Australia, 6150, Australia
Linz , 4020, Austria
Wien , 1160, Austria
Gent Oost-Vlaanderen, 9000, Belgium
Anderlecht , 1070, Belgium
Hasselt , 3500, Belgium
Liege , 4000, Belgium
Brasilia Distrito Federal, 70200, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Ijui RIO Grande DO SUL, 98700, Brazil
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Barretos Sao Paulo, 14780, Brazil
São Paulo SAO Paulo, 05652, Brazil
Rio de Janeiro , 20775, Brazil
Sao Paulo , 01246, Brazil
Vancouver British Columbia, V5Z 4, Canada
Saint John New Brunswick, E2L 3, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Rimouski Quebec, G5L 5, Canada
La Serena Coquimbo, 17204, Chile
Santiago Metropolitana, 0, Chile
Santiago Metropolitana, 75007, Chile
Santiago Metropolitana, 84203, Chile
Vina del Mar Valparaiso, 25205, Chile
Beijing Beijing, 10003, China
Beijing Beijing, 10003, China
Beijing Beijing, 10085, China
Fuzhou Fujian, 35000, China
Guangzhou Guangdong, 51012, China
Wuhan Hebei, 43003, China
Wuhan Hubei, 43006, China
Nanjing Jiangsu, 21002, China
Nanchang Jiangxi, 0, China
Changchun Jilin, 13002, China
Xi'an Shan3xi, 71006, China
Yantai Shandong, 26400, China
Shanghai Shanghai, 20002, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20004, China
Shanghai Shanghai, 20043, China
Chengdu Sichuan, 61004, China
Chengdu Sichuan, 61007, China
Tianjin Tianjin, 30022, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Guangzhou , 0, China
Nanjing , 21000, China
Shanghai , 20003, China
Medellin Antioquia, 05003, Colombia
Valledupar Cesar, 20000, Colombia
Bogotá , 11151, Colombia
Floridablanca , 0, Colombia
Pereira , 99999, Colombia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Besançon Cedex , 25030, France
Bordeaux , 33000, France
La Roche-Sur-Yon Cedex 9 , 85925, France
Lyon Cedex 08 , 69373, France
Marseille Cedex 9 , 13273, France
Paris , 75015, France
Rennes , 35042, France
Strasbourg , 67200, France
Toulouse Cedex 9 , 31059, France
Tours Cedex , 37044, France
Vandoeuvre Les Nancy , 54511, France
Villejuif , 94800, France
Tubingen Baden-Württemberg, 72076, Germany
Aachen , 52074, Germany
Essen , 45147, Germany
Hamburg , 22763, Germany
Hannover , 30559, Germany
Hannover , 30625, Germany
Jena , 07747, Germany
Munich , 81377, Germany
Nuernberg , 90419, Germany
Rostock , 18057, Germany
Wuerzburg , 97080, Germany
Arezzo , 52100, Italy
Cremona , 26100, Italy
Napoli , 80131, Italy
Parma , 43100, Italy
Roma , 00168, Italy
Verona , 37134, Italy
Toyoake Shi Aichi, 47011, Japan
Hirosaki-shi Aomori, 03685, Japan
Chiba-shi Chiba, 260-8, Japan
Fukuoka-shi Fukuoka, 81285, Japan
Sapporo-shi Hokkaido, 06086, Japan
Kobe-shi Hyogo, 65000, Japan
Tsukuba-shi Ibaraki, 30585, Japan
Shiwa-gun Iwate, 02836, Japan
Yokohama-shi Kanagawa, 23600, Japan
Kumamoto-shi Kumamoto, 860-0, Japan
Kamigyo-ku Kyoto, 602-8, Japan
Nagasaki-shi Nagasaki, 85281, Japan
Niigata-shi Niigata, 95185, Japan
Osakasayama-shi Osaka, 58985, Japan
Suita-shi Osaka, 565-0, Japan
Tokushima-shi Tokushima, 770-8, Japan
Adachi-ku Tokyo, 12308, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Shinjuku-Ku Tokyo, 16085, Japan
Yamagata-shi Yamagata, 99095, Japan
Ube-shi Yamaguchi, 75585, Japan
Hiroshima , 734-8, Japan
Wakayama , 641-8, Japan
Tijuana BAJA California, 22010, Mexico
Tuxtla Gutierrez Chiapas, 29090, Mexico
Torreón Coahuila, 27010, Mexico
Ciudad de Mexico Distrito Federal, 03100, Mexico
Tlalpan Distrito Federal, 14080, Mexico
Zapopan Jalisco, 45030, Mexico
Mazatlan Sinaloa, 82110, Mexico
Merida Yucatan, 97070, Mexico
Chihuahua , 31000, Mexico
Monterrey, NL , 64060, Mexico
San Luis Potosi , 78250, Mexico
Amsterdam , 1066 , Netherlands
Rotterdam , 3008 , Netherlands
Zwolle , 8025 , Netherlands
Bydgoszcz , 85-79, Poland
Wroclaw , 53-41, Poland
Bucharest , 02232, Romania
Cluj-Napoca , 40001, Romania
Cluj , 40001, Romania
Craiova , 20054, Romania
Iași , 70048, Romania
Moscow , 11799, Russian Federation
Novosibirsk , 63009, Russian Federation
Saint-Petersburg , 19404, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Singapore Central Singapore, 16858, Singapore
Singapore , 11907, Singapore
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Caceres , 10003, Spain
Cordoba , 14004, Spain
Lugo , 27003, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Sabadell , 08208, Spain
Sevilla , 41013, Spain
Chur , 7000, Switzerland
Sankt Gallen , 9007, Switzerland
Zuerich , 8091, Switzerland
Ankara , 06590, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Southampton Hampshire, SO16 , United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
Preston , PR2 9, United Kingdom
Swansea , SA2 8, United Kingdom
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