An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
NCT ID: NCT03662659
Last Updated: 2025-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
274 participants
INTERVENTIONAL
2018-10-16
2024-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
BMS-986213
Relatlimab + Nivolumab specified dose on specified days
Nivolumab
Specified dose on specified days
XELOX
Oxaliplatin + capecitabine
FOLFOX
Oxaliplatin + leucovorin + fluorouracil
SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium
Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
Nivolumab
Specified dose on specified days
XELOX
Oxaliplatin + capecitabine
FOLFOX
Oxaliplatin + leucovorin + fluorouracil
SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium
Interventions
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BMS-986213
Relatlimab + Nivolumab specified dose on specified days
Nivolumab
Specified dose on specified days
XELOX
Oxaliplatin + capecitabine
FOLFOX
Oxaliplatin + leucovorin + fluorouracil
SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
* No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
* Tumor tissue must be provided for biomarker analyses
Exclusion Criteria
* Participants with known untreated central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0049
Clovis, California, United States
Local Institution - 0064
Duarte, California, United States
Scripps Clinic
La Jolla, California, United States
Local Institution - 0040
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Local Institution - 0041
Orange, California, United States
Local Institution - 0077
Santa Monica, California, United States
Local Institution - 0056
Aurora, Colorado, United States
Local Institution - 0062
New Haven, Connecticut, United States
Local Institution - 0050
Hackensack, New Jersey, United States
Local Institution - 0054
Dallas, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Local Institution - 0052
Seattle, Washington, United States
Local Institution - 0010
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0009
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0011
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0078
CABA, , Argentina
Local Institution - 0027
Westmead, New South Wales, Australia
Local Institution - 0007
Herston, Queensland, Australia
Local Institution - 0003
Heidelberg, Victoria, Australia
Local Institution - 0029
Malvern, Victoria, Australia
Local Institution - 0008
Shepparton, Victoria, Australia
Local Institution - 0005
Murdoch, Western Australia, Australia
Local Institution - 0028
Bedford Park, , Australia
Local Institution - 0090
Graz, , Austria
Local Institution - 0089
Vienna, , Austria
Local Institution - 0091
Brussels, , Belgium
Local Institution - 0092
Leuven, , Belgium
Local Institution - 0024
Kelowna, British Columbia, Canada
Local Institution - 0063
Halifax, Nova Scotia, Canada
Local Institution - 0070
Toronto, Ontario, Canada
Local Institution - 0095
Québec, Quebec, Canada
Local Institution - 0055
Trois-Rivières, Quebec, Canada
Local Institution - 0002
Rancagua, L.g.bernardoohiggins, Chile
Local Institution - 0001
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0080
Santiago, Santiago Metropolitan, Chile
Local Institution - 0079
Santiago, , Chile
Local Institution - 0031
Brno, , Czechia
Local Institution - 0030
Olomouc, , Czechia
Local Institution - 0047
Avignon, , France
Local Institution - 0073
Besançon, , France
Local Institution - 0045
Dijon, , France
Local Institution - 0071
Montpellier, , France
Local Institution - 0043
Paris, , France
Local Institution - 0072
Paris, , France
Local Institution - 0046
Rouen, , France
Local Institution - 0083
Cologne, , Germany
Local Institution - 0082
Dresden, , Germany
Local Institution - 0017
Essen, , Germany
Local Institution - 0081
Essen, , Germany
Local Institution - 0014
Frankfurt, , Germany
Local Institution - 0018
Hamburg, , Germany
Local Institution - 0012
Hanover, , Germany
Local Institution - 0013
Heidelberg, , Germany
Local Institution - 0015
Mannheim, , Germany
Local Institution - 0016
Marburg, , Germany
Local Institution - 0020
Milan, , Italy
IRCCS Istituto Nazionale Tumori Milano
Milan, , Italy
Local Institution - 0021
Roma, , Italy
Local Institution - 0088
Bergen, , Norway
Local Institution - 0086
Oslo, , Norway
Local Institution - 0087
Trondheim, , Norway
Local Institution - 0093
Warsaw, , Poland
Local Institution - 0067
San Juan, , Puerto Rico
Local Institution - 0038
Singapore, , Singapore
Local Institution - 0058
Madrid, M, Spain
Local Institution - 0099
Badajoz, , Spain
Local Institution - 0098
Barcelona, , Spain
Local Institution - 0061
Barcelona, , Spain
Local Institution - 0059
Bilbao, , Spain
Local Institution - 0057
Madrid, , Spain
Local Institution - 0060
Zaragoza, , Spain
Local Institution - 0075
Manchester, Greater Manchester, United Kingdom
Local Institution - 0035
Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0032
Coventry, West Midlands, United Kingdom
Local Institution - 0036
Lancaster, , United Kingdom
Local Institution - 0034
London, , United Kingdom
Local Institution - 0069
Northwood, , United Kingdom
Local Institution - 0033
Southampton, , United Kingdom
Countries
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References
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Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K, Van Cutsem E, Al-Batran SE, Mansoor W, Maisey N, Pazo Cid R, Burge M, Perez-Callejo D, Hipkin RW, Mukherjee S, Lei M, Tang H, Suryawanshi S, Kelly RJ, Tebbutt NC. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. J Clin Oncol. 2024 Jun 10;42(17):2080-2093. doi: 10.1200/JCO.23.01636. Epub 2024 May 9.
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-001069-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA224-060
Identifier Type: -
Identifier Source: org_study_id
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