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.

View Full Description

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).

View Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

1653

Study ID:

NCT03138512

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 189 Locations for this study

See Locations Near You

Local Institution - 0019
Birmingham Alabama, 35205, United States
Local Institution - 0056
Springdale Arkansas, 72762, United States
Local Institution - 0186
Los Angeles California, 90048, United States
Local Institution - 0180
Los Angeles California, 90095, United States
Local Institution - 0002
San Francisco California, 94115, United States
Local Institution - 0185
Aurora Colorado, 80045, United States
Local Institution - 0016
Athens Georgia, 30607, United States
Local Institution - 0005
Chicago Illinois, 60611, United States
Local Institution
Chicago Illinois, 60612, United States
Local Institution - 0006
Saint Louis Missouri, 63110, United States
Local Institution - 0012
Howell New Jersey, 07731, United States
Local Institution - 0007
Buffalo New York, 14263, United States
Local Institution - 0181
New York New York, 10029, United States
Local Institution - 0001
New York New York, 10065, United States
Local Institution - 0008
Columbus Ohio, 43210, United States
Local Institution - 0009
Portland Oregon, 97213, United States
Local Institution - 0010
Allentown Pennsylvania, 18103, United States
Local Institution - 0014
Greenville South Carolina, 29607, United States
Local Institution - 0013
Chattanooga Tennessee, 37404, United States
Local Institution - 0183
Nashville Tennessee, 37232, United States
Local Institution - 0057
Fairfax Virginia, 22031, United States
Local Institution - 0178
Capital Federal Buenos Aires, 1280, Argentina
Local Institution - 0126
Ciudad Autonoma de Buenos Aires Buenos Aires, 1425, Argentina
Local Institution - 0203
Ciudad Autónoma De Buenos Aires Buenos Aires, 1426, Argentina
Local Institution - 0095
Mar Del Plata Buenos Aires, 7600, Argentina
Local Institution - 0208
Mar Del Plata Buenos Aires, B7600, Argentina
Local Institution - 0173
Rio Cuarto Cordoba, 5800, Argentina
Local Institution - 0232
Bariloche RIO Negro, 0, Argentina
Local Institution - 0179
Buenos Aires , C1419, Argentina
Local Institution - 0099
Caba , 1199, Argentina
Local Institution - 0096
Cordoba , 5000, Argentina
Local Institution - 0098
Cordoba , X5004, Argentina
Local Institution - 0164
San Juan , 5402, Argentina
Local Institution - 0097
Tucuman , 4000, Argentina
Local Institution - 0215
Macquarie Park New South Wales, 2109, Australia
Local Institution - 0032
Northmead New South Wales, 2152, Australia
Local Institution - 0036
Randwick New South Wales, 2031, Australia
Local Institution - 0035
St Leonards New South Wales, 2065, Australia
Local Institution - 0113
South Brisbane Queensland, 4101, Australia
Local Institution - 0213
Southport Queensland, 4215, Australia
Local Institution - 0034
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0033
Clayton Victoria, 0, Australia
Local Institution - 0214
Heidelberg Victoria, 3084, Australia
Local Institution - 0031
Murdoch Western Australia, 6150, Australia
Local Institution - 0068
Linz , 4020, Austria
Local Institution - 0084
Wien , 1160, Austria
Local Institution - 0058
Gent Oost-Vlaanderen, 9000, Belgium
Local Institution - 0064
Anderlecht , 1070, Belgium
Local Institution - 0060
Hasselt , 3500, Belgium
Local Institution - 0059
Liege , 4000, Belgium
Local Institution - 0047
Brasilia Distrito Federal, 70200, Brazil
Local Institution - 0045
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0046
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0048
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0043
Barretos Sao Paulo, 14780, Brazil
Local Institution - 0044
São Paulo SAO Paulo, 05652, Brazil
Local Institution - 0160
Rio de Janeiro , 20775, Brazil
Local Institution - 0050
Sao Paulo , 01246, Brazil
Local Institution - 0041
Vancouver British Columbia, V5Z 4, Canada
Local Institution - 0086
Saint John New Brunswick, E2L 3, Canada
Local Institution - 0087
Oshawa Ontario, L1G 2, Canada
Local Institution - 0112
Toronto Ontario, M5G 2, Canada
Local Institution - 0042
Montreal Quebec, H2X 0, Canada
Local Institution - 0040
Rimouski Quebec, G5L 5, Canada
Local Institution - 0223
La Serena Coquimbo, 17204, Chile
Local Institution - 0246
Santiago Metropolitana, 0, Chile
Local Institution
Santiago Metropolitana, 75007, Chile
Local Institution - 0221
Santiago Metropolitana, 84203, Chile
Local Institution - 0222
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0147
Beijing Beijing, 10003, China
Local Institution - 0153
Beijing Beijing, 10003, China
Local Institution - 0159
Beijing Beijing, 10085, China
Local Institution - 0132
Fuzhou Fujian, 35000, China
Local Institution - 0141
Guangzhou Guangdong, 51012, China
Local Institution - 0194
Wuhan Hebei, 43003, China
Local Institution - 0133
Wuhan Hubei, 43006, China
Local Institution - 0138
Nanjing Jiangsu, 21002, China
Local Institution - 0140
Nanchang Jiangxi, 0, China
Local Institution - 0145
Changchun Jilin, 13002, China
Local Institution - 0144
Xi'an Shan3xi, 71006, China
Local Institution - 0146
Yantai Shandong, 26400, China
Local Institution - 0137
Shanghai Shanghai, 20002, China
Local Institution - 0166
Shanghai Shanghai, 20003, China
Local Institution - 0152
Shanghai Shanghai, 20004, China
Local Institution - 0148
Shanghai Shanghai, 20043, China
Local Institution - 0142
Chengdu Sichuan, 61004, China
Local Institution - 0143
Chengdu Sichuan, 61007, China
Local Institution - 0175
Tianjin Tianjin, 30022, China
Local Institution - 0157
Hangzhou Zhejiang, 31000, China
Local Institution - 0131
Hangzhou Zhejiang, 31001, China
Local Institution - 0134
Guangzhou , 0, China
Local Institution - 0139
Nanjing , 21000, China
Local Institution - 0176
Shanghai , 20003, China
Local Institution - 0227
Medellin Antioquia, 05003, Colombia
Local Institution - 0228
Valledupar Cesar, 20000, Colombia
Local Institution - 0229
Bogotá , 11151, Colombia
Local Institution - 0230
Floridablanca , 0, Colombia
Local Institution - 0226
Pereira , 99999, Colombia
Local Institution - 0094
Hradec Kralove , 500 0, Czechia
Local Institution - 0025
Olomouc , 779 0, Czechia
Local Institution - 0083
Besançon Cedex , 25030, France
Local Institution - 0080
Bordeaux , 33000, France
Local Institution - 0082
La Roche-Sur-Yon Cedex 9 , 85925, France
Local Institution - 0116
Lyon Cedex 08 , 69373, France
Local Institution - 0079
Marseille Cedex 9 , 13273, France
Local Institution - 0198
Paris , 75015, France
Local Institution - 0081
Rennes , 35042, France
Local Institution - 0077
Strasbourg , 67200, France
Local Institution - 0115
Toulouse Cedex 9 , 31059, France
Local Institution - 0150
Tours Cedex , 37044, France
Local Institution - 0078
Vandoeuvre Les Nancy , 54511, France
Local Institution - 0076
Villejuif , 94800, France
Local Institution - 0217
Tubingen Baden-Württemberg, 72076, Germany
Local Institution - 0053
Aachen , 52074, Germany
Local Institution - 0103
Essen , 45147, Germany
Local Institution - 0052
Hamburg , 22763, Germany
Local Institution - 0231
Hannover , 30559, Germany
Local Institution - 0061
Hannover , 30625, Germany
Local Institution - 0062
Jena , 07747, Germany
Local Institution - 0102
Munich , 81377, Germany
Local Institution - 0054
Nuernberg , 90419, Germany
Local Institution - 0055
Rostock , 18057, Germany
Local Institution - 0101
Wuerzburg , 97080, Germany
Local Institution - 0105
Arezzo , 52100, Italy
Local Institution - 0172
Cremona , 26100, Italy
Local Institution - 0106
Napoli , 80131, Italy
Local Institution - 0107
Parma , 43100, Italy
Local Institution - 0109
Roma , 00168, Italy
Local Institution - 0108
Verona , 37134, Italy
Local Institution - 0129
Toyoake Shi Aichi, 47011, Japan
Local Institution - 0193
Hirosaki-shi Aomori, 03685, Japan
Local Institution - 0158
Chiba-shi Chiba, 260-8, Japan
Local Institution - 0121
Fukuoka-shi Fukuoka, 81285, Japan
Local Institution - 0156
Sapporo-shi Hokkaido, 06086, Japan
Local Institution - 0167
Kobe-shi Hyogo, 65000, Japan
Local Institution - 0191
Tsukuba-shi Ibaraki, 30585, Japan
Local Institution - 0168
Shiwa-gun Iwate, 02836, Japan
Local Institution - 0128
Yokohama-shi Kanagawa, 23600, Japan
Local Institution - 0216
Kumamoto-shi Kumamoto, 860-0, Japan
Local Institution - 0130
Kamigyo-ku Kyoto, 602-8, Japan
Local Institution - 0123
Nagasaki-shi Nagasaki, 85281, Japan
Local Institution - 0120
Niigata-shi Niigata, 95185, Japan
Local Institution - 0125
Osakasayama-shi Osaka, 58985, Japan
Local Institution - 0122
Suita-shi Osaka, 565-0, Japan
Local Institution - 0162
Tokushima-shi Tokushima, 770-8, Japan
Local Institution - 0188
Adachi-ku Tokyo, 12308, Japan
Local Institution - 0189
Bunkyo-ku Tokyo, 113-8, Japan
Local Institution - 0119
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0149
Shinjuku-Ku Tokyo, 16085, Japan
Local Institution - 0163
Ube-shi Yamaguchi, 75585, Japan
Local Institution - 0165
Hiroshima , 734-8, Japan
Local Institution - 0192
Wakayama , 641-8, Japan
Local Institution - 0127
Yamagata , 990-9, Japan
Local Institution - 0242
Tijuana BAJA California, 22010, Mexico
Local Institution - 0197
Tuxtla Gutierrez Chiapas, 29090, Mexico
Local Institution - 0195
Torreón Coahuila, 27010, Mexico
Local Institution - 0151
Ciudad de Mexico Distrito Federal, 03100, Mexico
Local Institution - 0111
Tlalpan Distrito Federal, 14080, Mexico
Local Institution - 0110
Zapopan Jalisco, 45030, Mexico
Local Institution - 0104
Mazatlan Sinaloa, 82110, Mexico
Local Institution - 0196
Merida Yucatan, 97070, Mexico
Local Institution - 0089
Chihuahua , 31000, Mexico
Local Institution - 0088
Monterrey, NL , 64060, Mexico
Local Institution - 0169
San Luis Potosi , 78250, Mexico
Local Institution - 0066
Amsterdam , 1066 , Netherlands
Local Institution - 0067
Rotterdam , 3008 , Netherlands
Local Institution - 0092
Zwolle , 8025 , Netherlands
Local Institution - 0155
Bydgoszcz , 85-79, Poland
Local Institution - 0038
Wroclaw , 53-41, Poland
Local Institution - 0243
Bucharest , 02232, Romania
Local Institution - 0200
Cluj-Napoca , 40001, Romania
Local Institution - 0247
Cluj , 40001, Romania
Local Institution - 0199
Craiova , 20054, Romania
Local Institution - 0202
Iași , 70048, Romania
Local Institution - 0065
Moscow , 11799, Russian Federation
Local Institution - 0170
Novosibirsk , 63009, Russian Federation
Local Institution - 0171
Saint-Petersburg , 19404, Russian Federation
Local Institution - 0021
Saint-Petersburg , 19825, Russian Federation
Local Institution - 0018
Singapore Central Singapore, 16858, Singapore
Local Institution - 0017
Singapore , 11907, Singapore
Local Institution - 0204
Barcelona , 08035, Spain
Local Institution - 0206
Barcelona , 08036, Spain
Local Institution - 0124
Caceres , 10003, Spain
Local Institution - 0207
Cordoba , 14004, Spain
Local Institution - 0118
Lugo , 27003, Spain
Local Institution - 0114
Madrid , 28034, Spain
Local Institution - 0205
Madrid , 28041, Spain
Local Institution - 0117
Sabadell , 08208, Spain
Local Institution - 0161
Sevilla , 41013, Spain
Local Institution - 0218
Chur , 7000, Switzerland
Local Institution - 0219
Sankt Gallen , 9007, Switzerland
Local Institution - 0225
Zuerich , 8091, Switzerland
Local Institution - 0209
Ankara , 06590, Turkey
Local Institution - 0210
Istanbul , 34098, Turkey
Local Institution
Istanbul , 34214, Turkey
Local Institution - 0075
Southampton Hampshire, SO16 , United Kingdom
Local Institution - 0063
Manchester , M20 4, United Kingdom
Local Institution - 0071
Northwood , HA6 2, United Kingdom
Local Institution - 0073
Preston , PR2 9, United Kingdom
Local Institution - 0072
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

1653

Study ID:

NCT03138512

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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