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Trial record 1 of 1 for:    CA209-914
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A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma (CheckMate 914)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138512
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether the combination of nivolumab and ipilimumab is safe and effective for delaying or preventing recurrence of cancer in patients who have experienced the partial or entire removal of a kidney

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Nivolumab Biological: Ipilimumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : September 5, 2022
Estimated Study Completion Date : July 7, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Module A: Nivolumab + Ipilimumab Biological: Nivolumab
Specified dose on specified days for 24 weeks
Other Name: Opdivo

Biological: Ipilimumab
Specified dose on specified days for 24 weeks
Other Name: Yervoy

Placebo Comparator: Module B: Placebo Drug: Placebo
Specified dose on specified days for 24 weeks




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: Up to 5 years ]
    Per Blinded Independent Central Review (BICR)


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Defined as the time between the date of randomization and the date of death

  2. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ]
    Safety and Tolerability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

  • Kidney tumor has been completely resected 4 to 12 weeks prior to randomization
  • Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
  • Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including participants with sarcomatoid features

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)
  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
  • Participants with a condition requiring systemic treatment with corticosteroids

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138512


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

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Locations
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United States, Alabama
Alabama Oncology Recruiting
Birmingham, Alabama, United States, 35205
Contact: Ira Gore, Site 0019    205-263-9746      
United States, Arkansas
Highland Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Joseph Thaddeus Beck, Site 0056    479-695-4167      
United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Site 0186         
Local Institution Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Site 0180         
California Pacific Medical Center Research Institute Recruiting
San Francisco, California, United States, 94115
Contact: Kevin Kim, Site 0002    415-600-5743      
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0185         
United States, Connecticut
Local Institution Withdrawn
New Haven, Connecticut, United States, 06510
United States, Georgia
University Cancer Blood Ctr Recruiting
Athens, Georgia, United States, 30607
Contact: Petros Nikolinakos, Site 0016    706-353-2990      
Local Institution Withdrawn
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jeffrey Sosman, Site 0005    312-695-2309      
United States, Indiana
Local Institution Withdrawn
Evansville, Indiana, United States, 47713
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Russell Pachynski, Site 0006    314-996-3452      
United States, New Jersey
Meridan Health System-Jersey Shore Medical Center Recruiting
Neptune, New Jersey, United States, 07753-4859
Contact: Kenneth Nahum, Site 0012    732-776-2421      
United States, New York
Local Institution Withdrawn
Albany, New York, United States, 12208
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Saby George, Site 0007    716-845-7754      
Local Institution Not yet recruiting
New York, New York, United States, 10029
Contact: Site 0181         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Robert Motzer, Site 0001    646-888-6732      
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Ming Yin, Site 0008    614-685-9955      
United States, Oregon
Providence Newburg Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, Site 0009    503-215-3943      
Local Institution Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Site 0187         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, Site 0010    610-402-1184      
United States, South Carolina
Bon Secours-St Francis Hosp Recruiting
Greenville, South Carolina, United States, 29607
Contact: Robert Siegel, Site 0014    864-603-6300      
United States, Tennessee
Erlanger Oncology & Hematology - Univ. of TN Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Robert Graham, Site 0013    423-778-2982      
Local Institution Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Site 0183         
United States, Utah
Local Institution Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site 0182         
United States, Virginia
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Contact: Jeanny Aragon-Ching, Site 0057    703-970-6488      
United States, Washington
Local Institution Withdrawn
Seattle, Washington, United States, 98195
Argentina
Local Institution Recruiting
Capital Federal, Buenos Aires, Argentina, 1419
Contact: Site 0179         
Hospital Privado De Comunidad Terminated
Mar Del Plata, Buenos Aires, Argentina, 7600
Instituto Medico Rio Cuarto S.A. Recruiting
Rio Cuarto, Cordoba, Argentina, 5800
Contact: Alejo Lingua, Site 0173    +543514142121      
Local Institution Recruiting
Buenos Aires, Argentina, C1431FWO
Contact: Site 0126         
Hospital Italiano De Buenos Aires Recruiting
Caba, Argentina, 1199
Contact: Jose Minatta, Site 0099    +541149590200      
Local Institution Withdrawn
Caba, Argentina, 1407
Hospital Britanico Recruiting
Capital federal, Argentina
Contact: , Site 0178    +43096897      
Instituto Oncologico De Cordoba Recruiting
Cordoba, Argentina, 5000
Contact: Martin Richardet, Site 0096    +543514601544      
Clinica Privada Universitaria Reina Fabiola Recruiting
Cordoba, Argentina, X5004FHP
Contact: Santiago Bella, Site 0098    +543514523885      
Centro Polivalente de Asistencia e Investigacion Clinica CER San Juan Recruiting
San Juan, Argentina, 5402
Contact: Juan Puig, Site 0164    +542644211086      
Centro Medico San Roque Terminated
Tucuman, Argentina, 4000
Australia, New South Wales
Prince Of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Elizabeth Jane Hovey, Site 0036    61293825125      
Royal North Shore Hospital Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Alexander Guminski, Site 0035    +61294631219      
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Howard Gurney, Site 0032    +61298459528      
Australia, Queensland
Integrated Clinical Oncology Network Pty Ltd (ICON) Recruiting
Chermside, Queensland, Australia, 4032
Contact: Jeffrey Goh, Site 0113    +61737374576      
Australia, Victoria
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3144
Contact: David Pook, Site 0033    61395083417      
Australia, Western Australia
St John of God Murdoch Hospital Recruiting
Perth, Western Australia, Australia, 6150
Contact: Kynan Feeney, Site 0031    +61894288556      
Australia
Lyell McEwin Hospital Recruiting
Elizabeth Vale, Australia, 5112
Contact: Christopher Hocking, Site 0034    +61882820833      
Austria
Krankenhaus der Elisabethinen Linz GmbH Recruiting
Linz, Austria, 4010
Contact: Wolfgang Loidl, Site 0068    +4373276774085      
Local Institution Recruiting
Wien, Austria, 1160
Contact: Site 0084         
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1000
Contact: Site 0064         
Local Institution Recruiting
Gent, Belgium, 9000
Contact: Site 0058         
Local Institution Recruiting
Hasselt, Belgium, 3500
Contact: Site 0060         
Local Institution Recruiting
Liege, Belgium, 4000
Contact: Site 0059         
Brazil
Local Institution Recruiting
Brasilia, Distrito Federal, Brazil, 70200-730
Contact: Site 0047         
Local Institution Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact: Site 0045         
Local Institution Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Site 0046         
Local Institution Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Contact: Site 0048         
Fundacao Pio Xii Hosp Cancer De Barretos Recruiting
Barretos, SAO Paulo, Brazil, 14784-400
Contact: Joao Neif Junior, Site 0043    +551733216637      
Local Institution Recruiting
Cerqueira Cesar, SAO Paulo, Brazil, 01246-000
Contact: Site 0050         
Local Institution Recruiting
Rio de Janeiro, Brazil, 22793-080
Contact: Site 0160         
Local Institution Recruiting
Sao Paulo, Brazil, 05651-901
Contact: Site 0044         
Canada, British Columbia
Local Institution Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0041         
Canada, New Brunswick
Local Institution Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Site 0086         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0112         
Canada, Quebec
Local Institution Recruiting
Rimouski, Quebec, Canada, G5L 5T1
Contact: Site 0040         
Canada
Local Institution Recruiting
Montreal, Canada, H2X 0A9
Contact: Site 0042         
Local Institution Recruiting
Oshawa, Canada, L1G 2B9
Contact: Site 0087         
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100034
Contact: Site 0153         
Local Institution Recruiting
Beijing, Beijing, China, 100730
Contact: Site 0147         
Local Institution Recruiting
Beijing, Beijing, China, 100853
Contact: Site 0159         
China, Fujian
Local Institution Recruiting
Fuzhou, Fujian, China, 350001
Contact: Site 0132         
China, Guangdong
Local Institution Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Site 0141         
China, Hubei
Local Institution Recruiting
Wuhan, Hubei, China, 430061
Contact: Site 0133         
China, Jiangsu
Local Institution Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Site 0139         
Local Institution Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Site 0138         
China, Jiangxi
Local Institution Recruiting
Nanchang, Jiangxi, China
Contact: Site 0140         
China, Jilin
Local Institution Recruiting
Changchun, Jilin, China, 130021
Contact: Site 0145         
China, Shandong
Local Institution Recruiting
Yantai, Shandong, China, 264000
Contact: Site 0146         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200025
Contact: Site 0137         
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0166         
Local Institution Recruiting
Shanghai, Shanghai, China, 200040
Contact: Site 0152         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Site 0148         
China, Sichuan
Local Institution Recruiting
Chengdu, Sichuan, China, 610041
Contact: Site 0142         
Local Institution Recruiting
Chengdu, Sichuan, China, 610072
Contact: Site 0143         
China, Tianjin
Local Institution Not yet recruiting
Tianjin, Tianjin, China, 300060
Contact: Site 0175         
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site 0157         
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Site 0131         
China
Local Institution Recruiting
Guangzhou, China
Contact: Site 0134         
Local Institution Not yet recruiting
Shanghai, China, 200032
Contact: Site 0176         
Local Institution Not yet recruiting
Shanghai, China
Contact: Site 0136         
Local Institution Not yet recruiting
Xi?an, China, 710061
Contact: Site 0144         
Czechia
Klinika onkologie a radioterapie Recruiting
Hradec Kralove, Czechia, 500 05
Contact: Jindrich Kopecky, Site 0094    +420495832176      
Onkologicka klinika Recruiting
Olomouc, Czechia, 779 00
Contact: Bohuslav Melichar, Site 0025    +420588444295      
France
Local Institution Recruiting
Besancon Cedex, France, 25030
Contact: Site 0083         
Local Institution Recruiting
La Roche sur Yon, France, 85320
Contact: Site 0082         
Local Institution Recruiting
Lyon Cedex 08, France, 69373
Contact: Site 0116         
Local Institution Recruiting
Marseille Cedex 9, France, 13273
Contact: Site 0079         
Local Institution Recruiting
Strasbourg, France, 67091
Contact: Site 0077         
Local Institution Recruiting
Tours Cedex, France, 37044
Contact: Site 0150         
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Site 0078         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0076         
Germany
Universitaetsklinikum Aachen Recruiting
Aachen, Germany, 52074
Contact: Julius van Essen, Site 0053    +492418036580      
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Viktor Gruenwald, Site 0103    +4920172383146      
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Christian Wuelfing, Site 0052    +49401818818635      
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Florian Imkamp, Site 0061    +495115323556      
Universitaetsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Marc-Oliver Grimm, Site 0062    +4936419329956      
Klinikum Grosshadern Recruiting
Munich, Germany, 81337
Contact: Michael Staehler, Site 0102    +4989440073722      
Klinikum Nuernberg Nord, Urologische Klinik Recruiting
Nuernberg, Germany, 90419
Contact: Sascha Pahernik, Site 0054    +499113983085      
Universitaetsklinikum Rostock Terminated
Rostock, Germany, 18057
Univ. Klinikum Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Hubert Kuebler, Site 0101    +4993120132030      
Italy
Local Institution Recruiting
Arezzo, Italy, 52100
Contact: Site 0105         
A.O. Istituti Ospitalieri Di Cremona Recruiting
Cremona, Italy, 26100
Contact: Rodolfo Passalacqua, Site 0172    +390372405414      
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli Recruiting
Napoli, Italy, 80123
Contact: Giacomo Carteni, Site 0106    +390817472106      
Azienda Ospedaliera Di Parma Recruiting
Parma, Italy, 43126
Contact: Sebastiano Buti, Site 0107    +390521991346      
Fondazione Policlinico Universitario A. Gemelli Recruiting
Roma, Italy, 00168
Contact: Giovanni Schinzari, Site 0109    +390630154945      
Policlinico G. Rossi Recruiting
Verona, Italy, 37134
Contact: Michele Milella, Site 0108    +390458124848 000 000 0000      
Japan
Local Institution Recruiting
Toyoake Shi, Aichi, Japan, 4701192
Contact: Site 0129         
Local Institution Recruiting
Hirosaki-shi, Aomori, Japan, 036-8563
Contact: Site 0193         
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 2608717
Contact: Site 0158         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 8128582
Contact: Site 0121         
Local Institution Recruiting
Hiroshima-Shi, Hiroshima, Japan, 7348551
Contact: Site 0165         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Contact: Site 0156         
Local Institution Recruiting
Kobe-shi, Hyogo, Japan, 6500017
Contact: Site 0167         
Local Institution Recruiting
Tsukuba-shi, Ibaraki, Japan, 3058576
Contact: Site 0191         
Local Institution Recruiting
Morioka-shi, Iwate, Japan, 0208505
Contact: Site 0168         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Contact: Site 0128         
Local Institution Recruiting
Kyoto-shi, Kyoto, Japan, 6028566
Contact: Site 0130         
Local Institution Recruiting
Nagasaki-shi, Nagasaki, Japan, 8528102
Contact: Site 0123         
Local Institution Recruiting
Niigata-shi, Niigata, Japan, 9518520
Contact: Site 0120         
Local Institution Recruiting
Osaka-sayama-shi, Osaka, Japan, 5898511
Contact: Site 0125         
Local Institution Recruiting
Suita-shi, Osaka, Japan, 5650871
Contact: Site 0122         
Local Institution Recruiting
Tokushima-shi, Tokushima, Japan, 7708503
Contact: Site 0162         
Local Institution Recruiting
Arakawa-ku, Tokyo, Japan, 1160011
Contact: Site 0188         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1130022
Contact: Site 0119         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138519
Contact: Site 0189         
Local Institution Recruiting
Shinjuku-Ku, Tokyo, Japan, 1608582
Contact: Site 0149         
Local Institution Recruiting
Wakayama-shi, Wakayama, Japan, 6418510
Contact: Site 0192         
Local Institution Recruiting
Yamagata-shi, Yamagata, Japan, 9909585
Contact: Site 0127         
Local Institution Recruiting
Ube-shi, Yamaguchi, Japan, 7558505
Contact: Site 0163         
Mexico
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 03810
Contact: Site 0151         
Local Institution Recruiting
Zapopan, Jalisco, Mexico, 45030
Contact: Site 0110         
Local Institution Recruiting
Monterrey, Nuevo LEON, Mexico, 64060
Contact: Site 0088         
Local Institution Withdrawn
Monterrey, Nuevo LEON, Mexico, 64710
Local Institution Active, not recruiting
Mazatlan, Sinaloa, Mexico, 82110
Local Institution Recruiting
Chihuahua, Mexico, 31000
Contact: Site 0089         
Local Institution Withdrawn
San Luis Potosi, Mexico, 78213
Local Institution Recruiting
San Luis Potosi, Mexico, 78250
Contact: Site 0169         
Local Institution Recruiting
Tlalpan, Mexico
Contact: Site 0111         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site 0066         
Local Institution Recruiting
Rotterdam, Netherlands, 3014 GD
Contact: Site 0067         
Local Institution Recruiting
Zwolle, Netherlands, 8025 AB
Contact: Site 0092         
Poland
Local Institution Withdrawn
Biala Podlaska, Poland, 21-500
Ambulatorium Chemioterapii Recruiting
Bydgoszcz, Poland, 85-796
Contact: Bogdan Zurawski, Site 0155    +48523743029      
Local Institution Withdrawn
Lublin, Poland, 20-362
Local Institution Withdrawn
Warsaw, Poland, 02-797
Oddzial Onkologii Klinicznej Recruiting
Wroclaw, Poland, 53-413
Contact: Krzysztof Tupikowski, Site 0038    +48713689677      
Russian Federation
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0023         
Local Institution Terminated
Moscow, Russian Federation, 117997
Local Institution Not yet recruiting
Moscow, Russian Federation, 125284
Contact: Site 0085         
Local Institution Not yet recruiting
Moscow, Russian Federation, 125367
Contact: Site 0174         
Local Institution Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603109
Contact: Site 0022         
Local Institution Recruiting
Novosibirsk, Russian Federation, 630099
Contact: Site 0170         
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 194044
Contact: Site 0171         
Local Institution Recruiting
St Petersburg, Russian Federation, 198255
Contact: Site 0021         
Singapore
Local Institution Completed
Singapore, Singapore, 119074
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0018         
Spain
Hospital San Pedro De Alcantara Recruiting
Caceres, Spain, 10003
Contact: Pablo Borrega Garcia, Site 0124    +34927256234      
H. Lucus Augusti Recruiting
Lugo, Spain, 27003
Contact: Sergio Vazquez Estevez, Site 0118    +34982296459      
Hospital Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Pablo Gajate, Site 0114    +34913368263      
Hospital Parc Tauli Recruiting
Sabadell, Spain, 08208
Contact: Enrique Gallardo, Site 0117    +34932607822      
Hosp. Univ. Virgen Del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Begona Perez Valderrama, Site 0161    +34955011368      
Local Institution Withdrawn
Sevilla, Spain, 41013
United Kingdom
Local Institution Withdrawn
Glasgow, Dumfries & Galloway, United Kingdom, G12 0YN
Local Institution Recruiting
Swansea, Glamorgan, United Kingdom, SA2 8QA
Contact: Site 0072         
Local Institution Recruiting
London, Greater London, United Kingdom, HA6 2RN
Contact: Site 0071         
Local Institution Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Site 0075         
Local Institution Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Site 0063         
Local Institution Recruiting
Preston, United Kingdom, PR2 9HT
Contact: Site 0073         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03138512     History of Changes
Other Study ID Numbers: CA209-914
2016-004502-34 ( EudraCT Number )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
localized; resected; adjuvant
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents