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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03138512
Other study ID # CA209-914
Secondary ID 2016-004502-34
Status Completed
Phase Phase 3
First received
Last updated
Start date July 7, 2017
Est. completion date February 1, 2024

Study information

Verified date February 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 1653
Est. completion date February 1, 2024
Est. primary completion date September 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
nivolumab
Specified dose on specified days
ipilimumab
Specified dose on specified days
Drug:
nivolumab placebo
Specified dose on specified days
ipilimumab placebo
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0232 Bariloche RIO Negro
Argentina Local Institution - 0179 Buenos Aires
Argentina Local Institution - 0099 Caba
Argentina Local Institution - 0178 Capital Federal Buenos Aires
Argentina Local Institution - 0126 Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Local Institution - 0203 Ciudad Autónoma De Buenos Aires Buenos Aires
Argentina Local Institution - 0096 Cordoba
Argentina Local Institution - 0098 Cordoba
Argentina Local Institution - 0095 Mar Del Plata Buenos Aires
Argentina Local Institution - 0208 Mar Del Plata Buenos Aires
Argentina Local Institution - 0173 Rio Cuarto Cordoba
Argentina Local Institution - 0164 San Juan
Argentina Local Institution - 0097 Tucuman
Australia Local Institution - 0033 Clayton Victoria
Australia Local Institution - 0034 Elizabeth Vale South Australia
Australia Local Institution - 0214 Heidelberg Victoria
Australia Local Institution - 0215 Macquarie Park New South Wales
Australia Local Institution - 0031 Murdoch Western Australia
Australia Local Institution - 0032 Northmead New South Wales
Australia Local Institution - 0036 Randwick New South Wales
Australia Local Institution - 0113 South Brisbane Queensland
Australia Local Institution - 0213 Southport Queensland
Australia Local Institution - 0035 St Leonards New South Wales
Austria Local Institution - 0068 Linz
Austria Local Institution - 0084 Wien
Belgium Local Institution - 0064 Anderlecht
Belgium Local Institution - 0058 Gent Oost-Vlaanderen
Belgium Local Institution - 0060 Hasselt
Belgium Local Institution - 0059 Liege
Brazil Local Institution - 0043 Barretos Sao Paulo
Brazil Local Institution - 0045 Belo Horizonte Minas Gerais
Brazil Local Institution - 0047 Brasilia Distrito Federal
Brazil Local Institution - 0046 Ijui RIO Grande DO SUL
Brazil Local Institution - 0048 Porto Alegre RIO Grande DO SUL
Brazil Local Institution - 0160 Rio de Janeiro
Brazil Local Institution - 0050 Sao Paulo
Brazil Local Institution - 0044 São Paulo SAO Paulo
Canada Local Institution - 0042 Montreal Quebec
Canada Local Institution - 0087 Oshawa Ontario
Canada Local Institution - 0040 Rimouski Quebec
Canada Local Institution - 0086 Saint John New Brunswick
Canada Local Institution - 0112 Toronto Ontario
Canada Local Institution - 0041 Vancouver British Columbia
Chile Local Institution - 0223 La Serena Coquimbo
Chile Local Institution Santiago Metropolitana
Chile Local Institution - 0221 Santiago Metropolitana
Chile Local Institution - 0246 Santiago Metropolitana
Chile Local Institution - 0222 Vina del Mar Valparaiso
China Local Institution - 0147 Beijing Beijing
China Local Institution - 0153 Beijing Beijing
China Local Institution - 0159 Beijing Beijing
China Local Institution - 0145 Changchun Jilin
China Local Institution - 0142 Chengdu Sichuan
China Local Institution - 0143 Chengdu Sichuan
China Local Institution - 0132 Fuzhou Fujian
China Local Institution - 0134 Guangzhou
China Local Institution - 0141 Guangzhou Guangdong
China Local Institution - 0131 Hangzhou Zhejiang
China Local Institution - 0157 Hangzhou Zhejiang
China Local Institution - 0140 Nanchang Jiangxi
China Local Institution - 0138 Nanjing Jiangsu
China Local Institution - 0139 Nanjing
China Local Institution - 0137 Shanghai Shanghai
China Local Institution - 0148 Shanghai Shanghai
China Local Institution - 0152 Shanghai Shanghai
China Local Institution - 0166 Shanghai Shanghai
China Local Institution - 0176 Shanghai
China Local Institution - 0175 Tianjin Tianjin
China Local Institution - 0133 Wuhan Hubei
China Local Institution - 0194 Wuhan Hebei
China Local Institution - 0144 Xi'an Shan3xi
China Local Institution - 0146 Yantai Shandong
Colombia Local Institution - 0229 Bogotá
Colombia Local Institution - 0230 Floridablanca
Colombia Local Institution - 0227 Medellin Antioquia
Colombia Local Institution - 0226 Pereira
Colombia Local Institution - 0228 Valledupar Cesar
Czechia Local Institution - 0094 Hradec Kralove
Czechia Local Institution - 0025 Olomouc
France Local Institution - 0083 Besançon Cedex
France Local Institution - 0080 Bordeaux
France Local Institution - 0082 La Roche-Sur-Yon Cedex 9
France Local Institution - 0116 Lyon Cedex 08
France Local Institution - 0079 Marseille Cedex 9
France Local Institution - 0198 Paris
France Local Institution - 0081 Rennes
France Local Institution - 0077 Strasbourg
France Local Institution - 0115 Toulouse Cedex 9
France Local Institution - 0150 Tours Cedex
France Local Institution - 0078 Vandoeuvre Les Nancy
France Local Institution - 0076 Villejuif
Germany Local Institution - 0053 Aachen
Germany Local Institution - 0103 Essen
Germany Local Institution - 0052 Hamburg
Germany Local Institution - 0061 Hannover
Germany Local Institution - 0231 Hannover
Germany Local Institution - 0062 Jena
Germany Local Institution - 0102 Munich
Germany Local Institution - 0054 Nuernberg
Germany Local Institution - 0055 Rostock
Germany Local Institution - 0217 Tubingen Baden-Württemberg
Germany Local Institution - 0101 Wuerzburg
Italy Local Institution - 0105 Arezzo
Italy Local Institution - 0172 Cremona
Italy Local Institution - 0106 Napoli
Italy Local Institution - 0107 Parma
Italy Local Institution - 0109 Roma
Italy Local Institution - 0108 Verona
Japan Local Institution - 0188 Adachi-ku Tokyo
Japan Local Institution - 0119 Bunkyo-ku Tokyo
Japan Local Institution - 0189 Bunkyo-ku Tokyo
Japan Local Institution - 0158 Chiba-shi Chiba
Japan Local Institution - 0121 Fukuoka-shi Fukuoka
Japan Local Institution - 0193 Hirosaki-shi Aomori
Japan Local Institution - 0165 Hiroshima
Japan Local Institution - 0130 Kamigyo-ku Kyoto
Japan Local Institution - 0167 Kobe-shi Hyogo
Japan Local Institution - 0216 Kumamoto-shi Kumamoto
Japan Local Institution - 0123 Nagasaki-shi Nagasaki
Japan Local Institution - 0120 Niigata-shi Niigata
Japan Local Institution - 0125 Osakasayama-shi Osaka
Japan Local Institution - 0156 Sapporo-shi Hokkaido
Japan Local Institution - 0149 Shinjuku-Ku Tokyo
Japan Local Institution - 0168 Shiwa-gun Iwate
Japan Local Institution - 0122 Suita-shi Osaka
Japan Local Institution - 0162 Tokushima-shi Tokushima
Japan Local Institution - 0129 Toyoake Shi Aichi
Japan Local Institution - 0191 Tsukuba-shi Ibaraki
Japan Local Institution - 0163 Ube-shi Yamaguchi
Japan Local Institution - 0192 Wakayama
Japan Local Institution - 0127 Yamagata
Japan Local Institution - 0128 Yokohama-shi Kanagawa
Mexico Local Institution - 0089 Chihuahua
Mexico Local Institution - 0151 Ciudad de Mexico Distrito Federal
Mexico Local Institution - 0104 Mazatlan Sinaloa
Mexico Local Institution - 0196 Merida Yucatan
Mexico Local Institution - 0088 Monterrey, NL
Mexico Local Institution - 0169 San Luis Potosi
Mexico Local Institution - 0242 Tijuana BAJA California
Mexico Local Institution - 0111 Tlalpan Distrito Federal
Mexico Local Institution - 0195 Torreón Coahuila
Mexico Local Institution - 0197 Tuxtla Gutierrez Chiapas
Mexico Local Institution - 0110 Zapopan Jalisco
Netherlands Local Institution - 0066 Amsterdam
Netherlands Local Institution - 0067 Rotterdam
Netherlands Local Institution - 0092 Zwolle
Poland Local Institution - 0155 Bydgoszcz
Poland Local Institution - 0038 Wroclaw
Romania Local Institution - 0243 Bucharest
Romania Local Institution - 0247 Cluj
Romania Local Institution - 0200 Cluj-Napoca
Romania Local Institution - 0199 Craiova
Romania Local Institution - 0202 Ia?i
Russian Federation Local Institution - 0065 Moscow
Russian Federation Local Institution - 0170 Novosibirsk
Russian Federation Local Institution - 0021 Saint-Petersburg
Russian Federation Local Institution - 0171 Saint-Petersburg
Singapore Local Institution - 0017 Singapore
Singapore Local Institution - 0018 Singapore Central Singapore
Spain Local Institution - 0204 Barcelona
Spain Local Institution - 0206 Barcelona
Spain Local Institution - 0124 Caceres
Spain Local Institution - 0207 Cordoba
Spain Local Institution - 0118 Lugo
Spain Local Institution - 0114 Madrid
Spain Local Institution - 0205 Madrid
Spain Local Institution - 0117 Sabadell
Spain Local Institution - 0161 Sevilla
Switzerland Local Institution - 0218 Chur
Switzerland Local Institution - 0219 Sankt Gallen
Switzerland Local Institution - 0225 Zuerich
Turkey Local Institution - 0209 Ankara
Turkey Local Institution Istanbul
Turkey Local Institution - 0210 Istanbul
United Kingdom Local Institution - 0063 Manchester
United Kingdom Local Institution - 0071 Northwood
United Kingdom Local Institution - 0073 Preston
United Kingdom Local Institution - 0075 Southampton Hampshire
United Kingdom Local Institution - 0072 Swansea
United States Local Institution - 0010 Allentown Pennsylvania
United States Local Institution - 0016 Athens Georgia
United States Local Institution - 0185 Aurora Colorado
United States Local Institution - 0019 Birmingham Alabama
United States Local Institution - 0007 Buffalo New York
United States Local Institution - 0013 Chattanooga Tennessee
United States Local Institution Chicago Illinois
United States Local Institution - 0005 Chicago Illinois
United States Local Institution - 0008 Columbus Ohio
United States Local Institution - 0057 Fairfax Virginia
United States Local Institution - 0014 Greenville South Carolina
United States Local Institution - 0012 Howell New Jersey
United States Local Institution - 0180 Los Angeles California
United States Local Institution - 0186 Los Angeles California
United States Local Institution - 0183 Nashville Tennessee
United States Local Institution - 0001 New York New York
United States Local Institution - 0181 New York New York
United States Local Institution - 0009 Portland Oregon
United States Local Institution - 0006 Saint Louis Missouri
United States Local Institution - 0002 San Francisco California
United States Local Institution - 0056 Springdale Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Germany,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival (DFS) as assessed by BICR (Part A and Part B) Up to 10 years
Secondary Overall Survival (OS) (Part A and Part B) Up to 10 years
Secondary Incidence of Adverse Events (AEs) (Part A and Part B) Up to 100 days after the last dose of study treatment
Secondary Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C) Up to 10 years
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