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Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

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: NCT02872116
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Cancer Drug: Nivolumab Drug: Ipilimumab Drug: Oxaliplatin Drug: Capecitabine Drug: Leucovorin Drug: Fluorouracil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : March 28, 2021
Estimated Study Completion Date : October 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy

Enrollment is closed for this arm

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Active Comparator: XELOX (Oxaliplatin + Capecitabine) Drug: Oxaliplatin
Specified dose on specified days

Drug: Capecitabine
Specified dose on specified days

Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil) Drug: Oxaliplatin
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days

Experimental: Nivolumab + XELOX Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Oxaliplatin
Specified dose on specified days

Drug: Capecitabine
Specified dose on specified days

Experimental: Nivolumab + FOLFOX Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Oxaliplatin
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days




Primary Outcome Measures :
  1. Overall survival (OS) of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in programmed cell death ligand 1 (PD-L1) positive participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  2. Progression-free survival (PFS), as assessed by Blinded Independent Central Review (BICR), of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in PD-L1 positive participants [ Time Frame: Up to 53 months after the first participant is randomized ]

Secondary Outcome Measures :
  1. OS in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  2. PFS, as assessed by BICR, in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  3. Objective Response Rate (ORR), as assessed by BICR, in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  4. Time to symptom deterioration (TTSD) of nivolumab + ipilimumab vs oxaliplatin + fluoropyrimidine in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
    Time to Symptom Deterioration assessed with Gastric Cancer Subscale questionnaire



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.


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

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

Inclusion Criteria:

  • Male or Female at least 18 years of age
  • Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
  • Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria:

  • Presence of tumor cells in the brain or spinal cord that have not been treated
  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection

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): NCT02872116


Contacts
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 #.

  Hide Study Locations
Locations
United States, California
Usc/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Syma Iqbal, Site 0005    323-865-0463      
California Pacific Medical Center Research Institute Recruiting
San Francisco, California, United States, 94115
Contact: Ari Baron, Site 0001    415-600-3472      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah Davis, Site 0066         
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Allen Cohn, Site 0151    281-863-6403      
United States, District of Columbia
Georgetown University Med Ctr Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sunnie Kim, Site 0136         
United States, Florida
Florida Cancer Specialists S. Recruiting
Fort Myers, Florida, United States, 33916
Contact: James Reeves, Site 0110         
Baptist Health Medical Group Oncology LLC Recruiting
Miami, Florida, United States, 33176-2118
Contact: Antonio Ucar, Site 0147    281-863-6403      
Florida Cancer Specialists Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Sunil Gandhi, Site 0111         
United States, Georgia
Northwest Georgia Oncology Center, P.C. Recruiting
Marietta, Georgia, United States, 30060
Contact: Steven McCune, Site 0179    770-281-5124      
United States, Illinois
Illinois Cancer Specialists Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Richard Siegel, Site 0219    281-863-6403      
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Victoria Villaflor, Site 0120    312-695-4781      
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kristen Marrone, Site 0021    410-502-3474      
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: James Cleary, Site 0135    617-975-7462      
Dana Farber Cancer Institute. Recruiting
Boston, Massachusetts, United States, 02215
Contact: James Cleary, Site 0002    617-632-3773      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Yelena Janjigian, Site 0003    646-888-4186      
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Joel Saltzman, Site 0138    216-844-6003      
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alok Khorana, Site 0186    216-636-2690      
United States, Oregon
Willamette Valley Cancer Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Joseph Fiorillo, Site 0146    281-863-6403      
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Usman Shah, Site 0015         
Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Blair Jobe, Site 0065         
United States, Tennessee
Tennessee Oncology, Pc Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell, Site 0104         
United States, Texas
Texas Oncology Recruiting
Bedford, Texas, United States, 76022
Contact: Henrik Bo Illum, Site 0140    281-863-6403      
Texas Oncology, Texas Cancer Center At Medical City Recruiting
Dallas, Texas, United States, 75230
Contact: Jay Courtright, Site 0143    281-863-6403      
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Andrew Paulson, Site 0213    281-863-6403      
The University Of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4009
Contact: Jaffer Ajani, Site 0004         
Texas Oncology-Plano East Active, not recruiting
Plano, Texas, United States, 75075-7787
United States, Virginia
Virginia Oncology Associates Recruiting
Newport News, Virginia, United States, 23606
Contact: David Chang, Site 0150    281-863-6403      
Argentina
Hospital Municipal De Gastroenterologia Dr.Udaondo Recruiting
Capital Federal, Buenos Aires, Argentina, 1264
Contact: Guillermo Mendez, Site 0028    +541143043202      
Hospital Britanico Recruiting
Capital Federal, Buenos Aires, Argentina, 1280
Contact: Luciana Bellaquero, Site 0029    +541143096400      
Clinica Viedma S.A. Recruiting
Viedma, RIO Negro, Argentina, 8500
Contact: Ruben Kowalyszyn, Site 0183    +542920428700      
Centro Para La Atencion Integral Del Paciente Oncologico Recruiting
San Miguel De Tucuman, Tucuman, Argentina, 4000
Contact: Felipe Palazzo, Site 0026    +543814215825      
Instituto Alexander Fleming Recruiting
Caba, Argentina, 1426
Contact: Juan Manuel Oconnor, Site 0030    +5411632232900      
Instituto Oncologico De Cordoba Recruiting
Cordoba, Argentina, 5000
Contact: Eduardo Richardet, Site 0027    +543512325689      
Local Institution Recruiting
La Rioja, Argentina, 5300
Contact: Site 0184         
Australia, New South Wales
Blacktown Hospital Recruiting
Blacktown, New South Wales, Australia, 2148
Contact: Adnan Nagrial, Site 0202    +61286705070      
Gosford Hospital Recruiting
Gosford, New South Wales, Australia, 2250
Contact: Craig Kukard, Site 0100    +61243209854      
Australia, Queensland
Tasman Oncology Research Pty Ltd Recruiting
Southport, Queensland, Australia, 4215
Contact: Andrew Hill, Site 0190    +61756132480      
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Nimit Singhal, Site 0101    +61870742361      
Australia, Victoria
Ballarat Base Hospital Recruiting
Ballarat, Victoria, Australia, 3350
Contact: Geoffrey Chong, Site 0103    +61353204735      
Goulburn Valley Health Recruiting
Shepparton, Victoria, Australia, 3630
Contact: Babak Tamjid, Site 0102    +61358323777      
Sunshine Hospital Recruiting
St Albans, Victoria, Australia, 3021
Contact: Sumitra Ananda, Site 0214    +61383959167      
Australia, Western Australia
St John of God Murdoch Hospital Recruiting
Perth, Western Australia, Australia, 6150
Contact: Kynan Feeney, Site 0099    +61894288556      
Local Institution Withdrawn
Subiaco, Western Australia, Australia, 6008
Brazil
Local Institution Recruiting
Salvador, Bahia, Brazil, 41950-610
Contact: Site 0053         
Local Institution Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Site 0046         
Local Institution Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Contact: Site 0047         
Local Institution Recruiting
Barretos, SAO Paulo, Brazil, 14784-400
Contact: Site 0048         
Local Institution Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Site 0054         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0035         
Canada, Ontario
Local Institution Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Site 0036         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Site 0067         
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0196         
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Frederic Lemay, Site 0068    819346111012848      
Local Institution Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Contact: Site 0034         
Canada
Centre Hospitalier De L'Universite De Montreal Recruiting
Montreal, Canada, H2X 3E4
Contact: Mustapha Tehfe, Site 0052    514890800026078      
CHU de Quebec - Universite Laval Recruiting
Quebec, Canada, G1R 2J6
Contact: Felix Couture, Site 0051    4186915781      
Chile
Clinica San Carlos de Apoquindo Recruiting
Santiago, Metropolitana, Chile, 8330024
Contact: Marcelo Garrido, Site 0057         
Fundacion Arturo Lopez Perez Recruiting
Santiago, Metropolitana, Chile
Contact: Pamela Salman, Site 0031    +5624457254      
Hospital Clinico de la Universidad De Chile Recruiting
Independencia, Santiago, Chile
Contact: Olga Barajas, Site 0058    +5624218596      
Instituto Oncologico Clinica Renaca Recruiting
Vina Del Mar, Valparaiso, Chile, 2540364
Contact: Pablo Gonzalez Mella, Site 0033    +56227541733      
ICOS - Inmunomedica Recruiting
Temuco, Chile, 4810297
Contact: Patricio Yanez, Site 0032    +56452201611      
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100001
Contact: Site 0176         
Local Institution Recruiting
Beijing, Beijing, China, 100032
Contact: Site 0178         
China, Chongqing
Local Institution Withdrawn
Chongqing, Chongqing, China, 400042
China, Fujian
Local Institution Recruiting
Fuzhou, Fujian, China, 350000
Contact: Site 0185         
China, Guangdong
Local Institution Active, not recruiting
Guangzhou, Guangdong, China, 510060
China, Heilongjiang
Local Institution Recruiting
Ha Erbin, Heilongjiang, China, 150040
Contact: Site 0160         
China, Henan
Local Institution Recruiting
Zhengzhou, Henan, China
Contact: Site 0159         
China, Hunan
Local Institution Recruiting
Changsha, Hunan, China
Contact: Site 0173         
China, Jiangsu
Local Institution Recruiting
Changzhou, Jiangsu, China, 213003
Contact: Site 0158         
Local Institution Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Site 0187         
Local Institution Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Site 0154         
China, Jilin
Local Institution Recruiting
Changchun, Jilin, China, 130012
Contact: Site 0156         
Local Institution Recruiting
Changchun, Jilin, China, 130021
Contact: Site 0155         
China, Liaoning
Local Institution Recruiting
Shenyang, Liaoning, China, 110046
Contact: Site 0181         
China, Shandong
Local Institution Recruiting
Qingdao, Shandong, China, 266061
Contact: Site 0182         
China, Shanghai
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0165         
Local Institution Recruiting
Shanghai, Shanghai, China, 200032
Contact: Site 0175         
China, Xinjiang
Local Institution Recruiting
Urumqi, Xinjiang, China, 830011
Contact: Site 0167         
China, Zhejiang
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site 0161         
Local Institution Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Site 0168         
China
Local Institution Recruiting
Beijing, China, 100142
Contact: Site 0171         
Local Institution Recruiting
Hangzhou, China, 310016
Contact: Site 0174         
Local Institution Recruiting
Tianjin, China, 300060
Contact: Site 0172         
Colombia
Local Institution Recruiting
Bogota, Cundinamarca, Colombia
Contact: Site 0025         
Administradora Del Country S.A. - Clinica Del Country Active, not recruiting
Bogota, Colombia
Local Institution Recruiting
Pasto, Colombia
Contact: Site 0024         
Czechia
Interni hematologicka a onkologicka klinika Recruiting
Brno, Czechia, 625 00
Contact: Zdenek Kral, Site 0200    +420532233642      
Klinika komplexni onkologicke pece Recruiting
Brno, Czechia, 656 53
Contact: Jiri Tomasek, Site 0197    +420777578407      
France
Local Institution Recruiting
Caen, France, 14000
Contact: Site 0080         
Local Institution Recruiting
Dijon, France, 21000
Contact: Site 0081         
Local Institution Recruiting
Lille, France, 59000
Contact: Site 0077         
Local Institution Recruiting
Montpellier, France, 34090
Contact: Site 0083         
Local Institution Recruiting
Nantes, France, 44000
Contact: Site 0113         
Local Institution Recruiting
Nice Cedex 2, France, 06189
Contact: Site 0079         
Local Institution Recruiting
Paris, France, 75012
Contact: Site 0078         
Local Institution Recruiting
Plerin, France, 22190
Contact: Site 0119         
Germany
Charite Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Contact: Peter Thuss-Patience, Site 0094    +4930450653868      
University Hospital Of Cologne Recruiting
Cologne, Germany, 50937
Contact: Thomas Zander, Site 0095    +4922147887009      
Universitaetsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Gunnar Folprecht, Site 0089    +493517965620      
Universitatsklinikum Dusseldorf Recruiting
Dusseldorf, Germany, 40225
Contact: Dirk Graf, Site 0188    +492118117820      
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Stefan Kasper, Site 0091    +492017231791      
Medizinische Universitaetsklinik Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Ralph Fritsch, Site 0096    +4976127073610      
Universitaets-Krankenhaus Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: Alexander Stein, Site 0093    +4940741056882      
Johannes -Gutenberg Universitat Recruiting
Mainz, Germany, 55131
Contact: Markus Moehler, Site 0092    +496131176863      
Klinikum Rechts Der Isar Recruiting
Muenchen, Germany, 81675
Contact: Sylvie Lorenzen, Site 0149    +498941409696      
Greece
Laiko General Hospital Of Athens Recruiting
Athens, Greece, 11526
Contact: Michalis Karamouzis, Site 0056    +302132060925      
Ioannina University Hospital Recruiting
Ioannina, Greece, 45500
Contact: George Pentheroudakis, Site 0019    +302651099394      
Agioi Anargyroi Cancer Center Recruiting
Nea Kifissia, Greece, 14564
Contact: Gerasimos Aravantinos, Site 0017    +302103501711      
University General Hospital of Patras Recruiting
Patras, Greece, 26504
Contact: Haralabos Kalofonos, Site 0018    +302610999535      
Hong Kong
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 0195         
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 0191         
Hungary
Semmelweis Egyetem Onkologiai Kozpont Recruiting
Budapest, Hungary, 1083
Contact: Magdolna Dank, Site 0008    +36208251749      
Orszagos Onkologiai Intezet Recruiting
Budapest, Hungary, 1122
Contact: Erika Hitre, Site 0007    +3612248763      
DE KK Onkologiai Intezet Recruiting
Debrecen, Hungary
Contact: Peter Arkosy, Site 0108    +3652255585      
Local Institution Withdrawn
Gyula, Hungary, 5700
Israel
Local Institution Recruiting
Haifa, Israel, 31096
Contact: Site 0118         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 0116         
Local Institution Recruiting
Petach Tikva, Israel, 49100
Contact: Site 0115         
Local Institution Recruiting
Ramat-gan, Israel, 52621
Contact: Site 0117         
Local Institution Recruiting
Tel Aviv, Israel, 64239
Contact: Site 0114         
Italy
ASST Papa Giovanni XXIII Active, not recruiting
Bergamo, Italy, 24127
Local Institution Withdrawn
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria Di Modena Recruiting
Modena, Italy, 41124
Contact: Gabriele Luppi, Site 0205    +390594222111      
Aorn Dei Colli Active, not recruiting
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Alfredo Falcone, Site 0063    +39050992466 000 000000      
Fondazione Policlinico Universitario A. Gemelli Recruiting
Roma, Italy, 00168
Contact: Michele Basso, Site 0059    +390630154953      
Osp. Casa Sollievo Della Sofferenza Active, not recruiting
San Giovanni Rotondo, Italy, 71013
Japan
Local Institution Active, not recruiting
Nagoya-shi, Aichi, Japan, 4640021
Local Institution Active, not recruiting
Chiba-shi, Chiba, Japan, 260-8717
Local Institution Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Site 0125         
Local Institution Active, not recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution Active, not recruiting
Suita-shi, Osaka, Japan, 5650871
Local Institution Active, not recruiting
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution Active, not recruiting
Chuo-ku, Tokyo, Japan, 1040045
Local Institution Active, not recruiting
Minato-ku, Tokyo, Japan, 1058470
Local Institution Active, not recruiting
Kita-gun, Japan, 7610793
Local Institution Active, not recruiting
Tokyo, Japan, 1358550
Korea, Republic of
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 05505
Local Institution Active, not recruiting
Seoul, Korea, Republic of, 3722
Mexico
Local Institution Recruiting
Mexico City, Distrito Federal, Mexico, 03100
Contact: Site 0215         
Local Institution Withdrawn
Tlalpan, Distrito Federal, Mexico, 14080
Local Institution Recruiting
Toluca, Estado DE Mexico, Mexico, 05440
Contact: Site 0217         
Local Institution Recruiting
Queretaro, Mexico, 76090
Contact: Site 0216         
Peru
Clinica Anglo Americana Recruiting
Lima, Peru, 27
Contact: Ashley Alarcon, Site 0189         
Instituto Nacional De Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Paola Montenegro, Site 0039    +51989118835      
Hospital Nacional Cayetano Heredia Recruiting
Lima, Peru, LIMA 31
Contact: Hermes Tejada, Site 0037    +51940563856      
Clinica Internacional sede San Borja Recruiting
Lima, Peru, Lima 41
Contact: Renzo Salas, Site 0139    +51997351143      
Poland
II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego Recruiting
Lublin, Poland, 20-081
Contact: Tomasz Skoczylas, Site 0016    +48695621774      
Local Institution Withdrawn
Nowy Sacz, Poland, 33-300
Centrum Onkologiczne: Oddzial Onkologii Klinicznej oraz Poradnia Onkologiczna Recruiting
Tarnobrzeg, Poland, 39-400
Contact: Iwona Drab-Mazur, Site 0013    +48158123030      
Klinika Gastroenterologii Onkologicznej Recruiting
Warszawa, Poland, 02-781
Contact: Lucjan Wyrwicz, Site 0014    +48225709263      
Portugal
Local Institution Recruiting
Lisboa, Portugal, 1649-035
Contact: Site 0043         
Local Institution Recruiting
Porto, Portugal, 4200-072
Contact: Site 0210         
Romania
Local Institution Recruiting
Baia Mare, JUD Maramures, Romania, 430291
Contact: Site 0012         
Local Institution Recruiting
Bucharest, Romania, 022328
Contact: Site 0040         
Local Institution Recruiting
Cluj-Napoca, Romania, 400015
Contact: Site 0042         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0041         
Local Institution Recruiting
Suceava, Romania, 720237
Contact: Site 0055         
Russian Federation
Local Institution Active, not recruiting
Chelyabinsk, Russian Federation, 454048
Local Institution Withdrawn
Kazan, Russian Federation, 420029
Local Institution Active, not recruiting
Moscow, Russian Federation, 115478
Local Institution Withdrawn
Moscow, Russian Federation, 115478
Local Institution Active, not recruiting
Moscow, Russian Federation, 121309
Local Institution Completed
Moscow, Russian Federation, 125284
Local Institution Withdrawn
Moscow, Russian Federation, 125367
Local Institution Withdrawn
St. Petersburg, Russian Federation, 197758
Local Institution Active, not recruiting
St. Petersburg, Russian Federation, 198255
Singapore
Local Institution Recruiting
Singapore, Singapore, 119228
Contact: Site 0194         
Local Institution Recruiting
Singapore, Singapore, 169610
Contact: Site 0193         
Spain
Local Institution Recruiting
Badajoz, Spain, 06006
Contact: Site 0050         
Local Institution Recruiting
Badalona-barcelona, Spain, 08916
Contact: Site 0209         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0044         
Local Institution Recruiting
Pozuelo De Alarcon, Madrid, Spain, 28223
Contact: Site 0049         
Local Institution Recruiting
Valencia, Spain, 46010
Contact: Site 0045         
Local Institution Recruiting
Zaragoza, Spain, 50009
Contact: Site 0212         
Taiwan
Local Institution Active, not recruiting
Tainan, Taiwan, 704
Local Institution Active, not recruiting
Taipei, Taiwan, 112
Local Institution Active, not recruiting
Taoyuan, Taiwan, 333
Turkey
Local Institution Recruiting
Ankara, Turkey, 06100
Contact: Site 0203         
Local Institution Recruiting
Ankara, Turkey, 06800
Contact: Site 0211         
Local Institution Recruiting
Antalya, Turkey, 07070
Contact: Site 0201         
Local Institution Recruiting
Diyarbak?r, Turkey, 21280
Contact: Site 0208         
Local Institution Recruiting
Edrine, Turkey, 22010
Contact: Site 0207         
Local Institution Not yet recruiting
Istanbul, Turkey, 34300
Contact: Site 0220         
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 0074         
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 0073         
Local Institution Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Site 0076         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 0075         
Local Institution Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Site 0072         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02872116     History of Changes
Other Study ID Numbers: CA209-649
2016-001018-76 ( EudraCT Number )
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
Oxaliplatin
Nivolumab
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents