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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02872116
Recruitment Status : Active, not recruiting
First Posted : August 19, 2016
Last Update Posted : June 4, 2020
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2032 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 : May 25, 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.


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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

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


Locations
Hide Hide 177 study locations
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United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Florida Cancer Specialists S.
Fort Myers, Florida, United States, 33916
Baptist Health Medical Group Oncology LLC
Miami, Florida, United States, 33176
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute.
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Tennessee Oncology, Pc
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology
Bedford, Texas, United States, 76022
Texas Oncology, Texas Cancer Center At Medical City
Dallas, Texas, United States, 75230
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Texas Oncology-Plano East
Plano, Texas, United States, 75075-7787
United States, Virginia
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Argentina
Instituto Alexander Fleming
Caba, Buenos Aires, Argentina, 1426
Hospital Municipal De Gastroenterologia Dr.Udaondo
Capital Federal, Buenos Aires, Argentina, 1264
Hospital Britanico
Capital Federal, Buenos Aires, Argentina, 1280
Clinica Viedma S.A.
Viedma, RIO Negro, Argentina, 8500
Centro Para La Atencion Integral Del Paciente Oncologico
San Miguel De Tucuman, Tucuman, Argentina, 4000
Instituto Oncologico De Cordoba
Cordoba, Argentina, 5000
Local Institution
La Rioja, Argentina, 5300
Australia, New South Wales
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Australia, Queensland
Tasman Oncology Research Pty Ltd
Southport, Queensland, Australia, 4215
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Ballarat Base Hospital
Ballarat, Victoria, Australia, 3350
Goulburn Valley Health
Shepparton, Victoria, Australia, 3630
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Australia, Western Australia
St John of God Murdoch Hospital
Perth, Western Australia, Australia, 6150
Brazil
Clinica AMO
Salvador, Bahia, Brazil, 41950-610
Associacao Hospital de Caridade Ijui
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Hospital de Clinicas de Porto Alegre HCPA
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, SAO Paulo, Brazil, 14784-400
Local Institution
Sao Paulo, Brazil, 01246-000
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
London, Ontario, Canada, N6A 4L6
Local Institution
Toronto, Ontario, Canada, M5G2M9
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Local Institution
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
Centre Hospitalier De L'Universite De Montreal
Montreal, Canada, H2X 3E4
CHU de Quebec - Universite Laval
Quebec, Canada, G1R 2J6
Chile
ICOS - Inmunomedica
Temuco, Araucania, Chile, 4810469
Clinica San Carlos de Apoquindo
Santiago, Metropolitana, Chile, 8330024
Fundacion Arturo Lopez Perez
Santiago, Metropolitana, Chile
Hospital Clinico de la Universidad De Chile
Independencia, Santiago, Chile
Instituto Oncologico Clinica Renaca
Vina Del Mar, Valparaiso, Chile, 2540364
China, Beijing
Local Institution
Beijing, Beijing, China, 100001
Local Institution
Beijing, Beijing, China, 100032
China, Fujian
Local Institution
Fuzhou, Fujian, China, 350000
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510060
China, Heilongjiang
Local Institution
Ha Erbin, Heilongjiang, China, 150040
China, Henan
Local Institution
Zhengzhou, Henan, China
China, Hunan
Local Institution
Changsha, Hunan, China
China, Jiangsu
Local Institution
Changzhou, Jiangsu, China, 213003
Local Institution
Nanjing, Jiangsu, China, 210000
Local Institution
Nanjing, Jiangsu, China, 210002
China, Jilin
Local Institution
Changchun, Jilin, China, 130012
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 110046
China, Shandong
Local Institution
Qingdao, Shandong, China, 266061
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200032
China, Xinjiang
Local Institution
Urumqi, Xinjiang, China, 830011
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310009
Local Institution
Hangzhou, Zhejiang, China, 310022
China
Local Institution
Beijing, China, 100142
Local Institution
Hangzhou, China, 310016
Local Institution
Tianjin, China, 300060
Colombia
Local Institution
Bogota, Cundinamarca, Colombia
Administradora Del Country S.A. - Clinica Del Country
Bogota, Colombia
Local Institution
Pasto, Colombia
Czechia
Interni hematologicka a onkologicka klinika
Brno, Czechia, 625 00
Klinika komplexni onkologicke pece
Brno, Czechia, 656 53
France
Centre Francois Baclesse
Caen, France, 14000
Centre Georges-Francois Leclerc
Dijon, France, 21000
Centre Oscar Lambret
Lille, France, 59000
Institut du Cancer de Montpellier
Montpellier, France, 34090
Hotel Dieu - Chu De Nantes
Nantes, France, 44000
Centre Antoine Lacassagne
Nice Cedex 2, France, 06189
Hopital Saint Antoine
Paris, France, 75012
Clinique Armoricaine De Radiologie
Plerin, France, 22190
Germany
Charite Campus Virchow Klinikum
Berlin, Germany, 13353
University Hospital Of Cologne
Cologne, Germany, 50937
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Universitatsklinikum Dusseldorf
Dusseldorf, Germany, 40225
Universitaetsklinikum Essen
Essen, Germany, 45122
Medizinische Universitaetsklinik Freiburg
Freiburg, Germany, 79106
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, 20251
Johannes -Gutenberg Universitat
Mainz, Germany, 55131
Klinikum Rechts Der Isar
Muenchen, Germany, 81675
Greece
Laiko General Hospital Of Athens
Athens, Greece, 11526
Ioannina University Hospital
Ioannina, Greece, 45500
General Oncology Hospital of Kifissia Agioi Anargyroi
Nea Kifisia, Greece, 14564
University General Hospital of Patras
Patras, Greece, 26504
Hong Kong
Local Institution
Hong Kong, Hong Kong
Hungary
Semmelweis Egyetem Onkologiai Kozpont
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet
Budapest, Hungary, 1122
DE KK Onkologiai Intezet
Debrecen, Hungary
Israel
Local Institution
Haifa, Israel, 31096
Local Institution
Jerusalem, Israel, 91120
Local Institution
Petach Tikva, Israel, 49100
Local Institution
Ramat-gan, Israel, 52621
Local Institution
Tel Aviv, Israel, 64239
Italy
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Azienda Ospedaliera Universitaria Di Modena
Modena, Italy, 41124
Aorn Dei Colli
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Fondazione Policlinico Universitario A. Gemelli
Roma, Italy, 00168
Osp. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy, 71013
Japan
Local Institution
Nagoya, Aichi, Japan, 4648681
Local Institution
Chiba-shi, Chiba, Japan, 260-8717
Local Institution
Kashiwa, Chiba, Japan, 277-8577
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Suita-shi, Osaka, Japan, 5650871
Local Institution
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Local Institution
Minato-ku, Tokyo, Japan, 1058470
Local Institution
Kita-gun, Japan, 7610793
Local Institution
Tokyo, Japan, 1358550
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 03722
Local Institution
Seoul, Korea, Republic of, 05505
Mexico
Local Institution
Mexico City, Distrito Federal, Mexico, 03100
Local Institution
Toluca, Estado DE Mexico, Mexico, 50120
Local Institution
Queretaro, Mexico, 76090
Peru
Clinica Anglo Americana
Lima, Peru, 27
Instituto Nacional De Enfermedades Neoplasicas
Lima, Peru, 34
Hospital Nacional Cayetano Heredia
Lima, Peru, LIMA 31
Clinica Internacional sede San Borja
Lima, Peru, Lima 41
Poland
II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego
Lublin, Poland, 20-081
Centrum Onkologiczne: Oddzial Onkologii Klinicznej oraz Poradnia Onkologiczna
Tarnobrzeg, Poland, 39-400
Klinika Onkologii i Radioterapii
Warszawa, Poland, 02-034
Portugal
Local Institution
Lisboa, Portugal, 1649-035
Local Institution
Porto, Portugal, 4200-072
Romania
Local Institution
Baia Mare, JUD Maramures, Romania, 430291
Local Institution
Bucharest, Romania, 022328
Local Institution
Cluj-Napoca, Romania, 400015
Local Institution
Craiova, Romania, 200347
Local Institution
Suceava, Romania, 720237
Russian Federation
Local Institution
Chelyabinsk, Russian Federation, 454048
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 121309
Local Institution
Moscow, Russian Federation, 125284
Local Institution
St. Petersburg, Russian Federation, 198255
Singapore
Local Institution
Singapore, Singapore, 119228
Local Institution
Singapore, Singapore, 169610
Spain
Local Institution
Badajoz, Spain, 06006
Local Institution
Badalona-barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08035
Local Institution
Pozuelo De Alarcon, Madrid, Spain, 28223
Local Institution
Valencia, Spain, 46010
Local Institution
Zaragoza, Spain, 50009
Taiwan
Local Institution
Tainan, Taiwan, 70403
Local Institution
Taipei, Taiwan, 112
Local Institution
Taoyuan, Taiwan, 333
Turkey
Local Institution
Ankara, Turkey, 06100
Local Institution
Ankara, Turkey, 06800
Local Institution
Antalya, Turkey, 07070
Local Institution
Diyarbak?r, Turkey, 21280
Local Institution
Edrine, Turkey, 22010
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
Local Institution
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Local Institution
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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: NCT02872116    
Other Study ID Numbers: CA209-649
2016-001018-76 ( EudraCT Number )
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Leucovorin
Fluorouracil
Capecitabine
Oxaliplatin
Nivolumab
Ipilimumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances