Carcinoma, Renal Cell Clinical Trial
— CheckMate 914Official title:
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Verified date | February 2024 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
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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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
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,
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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