An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
NCT ID: NCT02869789
Last Updated: 2023-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1041 participants
INTERVENTIONAL
2016-10-05
2022-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab in combination with Ipilimumab
Specified dose on specified days
Nivolumab in combination with Ipilimumab
Specified dose on specified days
Interventions
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Nivolumab in combination with Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available
* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
* High Tumor Mutation Burden
Exclusion Criteria
* An active malignancy that requires concurrent intervention
* Active, known or suspected autoimmune disease
* Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
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 - 0121
Birmingham, Alabama, United States
Local Institution - 0148
Phoenix, Arizona, United States
Local Institution - 0085
Tucson, Arizona, United States
Local Institution - 0164
Little Rock, Arkansas, United States
Local Institution - 0146
Bakersfield, California, United States
Marin Cancer Care, Inc
Greenbrae, California, United States
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States
Local Institution - 0115
Los Angeles, California, United States
Torrance Health Association
Redondo Beach, California, United States
Va San Diego Healthcare System
San Diego, California, United States
Local Institution - 0143
San Luis Obispo, California, United States
Local Institution - 0144
Santa Maria, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Local Institution - 0161
Whittier, California, United States
Local Institution - 0083
Denver, Colorado, United States
Local Institution - 0141
Grand Junction, Colorado, United States
Cancer Specialists of North FL
Jacksonville, Florida, United States
Local Institution - 0082
Ocala, Florida, United States
Local Institution - 0147
Pembroke Pines, Florida, United States
Local Institution - 0163
Athens, Georgia, United States
Local Institution - 0002
Atlanta, Georgia, United States
Local Institution - 0166
Atlanta, Georgia, United States
Local Institution - 0088
Niles, Illinois, United States
Local Institution - 0108
Wichita, Kansas, United States
Kentucky One Health St. Joseph East Cancer Center
Lexington, Kentucky, United States
Local Institution - 0091
Columbia, Maryland, United States
Local Institution - 0089
Edina, Minnesota, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States
Local Institution - 0077
Grand Island, Nebraska, United States
Local Institution - 0087
Las Vegas, Nevada, United States
Local Institution - 0170
Reno, Nevada, United States
Local Institution - 0156
Belleville, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Local Institution - 0142
Livingston, New Jersey, United States
Local Institution - 0167
The Bronx, New York, United States
Local Institution - 0004
Durham, North Carolina, United States
Local Institution - 0012
Winston-Salem, North Carolina, United States
Local Institution - 0100
Cincinnati, Ohio, United States
Local Institution - 0134
Cleveland, Ohio, United States
Local Institution - 0172
Corvallis, Oregon, United States
Local Institution - 0096
Eugene, Oregon, United States
Local Institution - 0176
Portland, Oregon, United States
Local Institution - 0139
Allentown, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Local Institution - 0159
Pittsburgh, Pennsylvania, United States
Local Institution - 0001
Sayre, Pennsylvania, United States
Local Institution - 0123
Charleston, South Carolina, United States
Local Institution - 0066
Chattanooga, Tennessee, United States
Local Institution - 0067
Nashville, Tennessee, United States
Local Institution - 0090
Austin, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Local Institution - 0149
Dallas, Texas, United States
Local Institution - 0094
Fort Worth, Texas, United States
Local Institution - 0093
Longview, Texas, United States
Local Institution - 0098
Plano, Texas, United States
Local Institution - 0086
Waco, Texas, United States
Local Institution - 0097
Fairfax, Virginia, United States
Local Institution - 0044
Richmond, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Local Institution - 0174
Renton, Washington, United States
Local Institution - 0173
Spokane, Washington, United States
Local Institution - 0008
Capital Federal, Buenos Aires, Argentina
Local Institution - 0006
Viedma, Río Negro Province, Argentina
Local Institution - 0007
CABA, , Argentina
Local Institution - 0009
Córdoba, , Argentina
Local Institution - 0126
San Miguel de Tucumán, , Argentina
Local Institution - 0038
Ghent, , Belgium
Local Institution - 0037
Liège, , Belgium
Local Institution - 0036
Sint-Niklaas, , Belgium
Local Institution - 0152
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0154
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0153
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0151
Barretos, São Paulo, Brazil
Local Institution - 0127
Greenfield Park, Quebec, Canada
Local Institution - 0109
Montreal, Quebec, Canada
Local Institution - 0049
Rimouski, Quebec, Canada
Local Institution - 0050
Trois-Rivières, Quebec, Canada
Local Institution - 0010
Santiago, Santiago Metropolitan, Chile
Local Institution - 0011
Santiago, , Chile
Local Institution - 0133
Nový Jičín, , Czechia
Local Institution - 0130
Prague, , Czechia
Local Institution - 0118
Bordeaux, , France
Local Institution - 0075
Dijon, , France
Local Institution - 0069
Marseille, , France
Local Institution - 0076
Paris, , France
Local Institution - 0074
Pessac, , France
Local Institution - 0071
Rennes, , France
Local Institution - 0070
Saint-Herblain, , France
Local Institution - 0072
Strasbourg, , France
Local Institution - 0073
Toulon, , France
Local Institution - 0023
Frankfurt, , Germany
Local Institution - 0028
Gera, , Germany
Local Institution - 0029
Kassel, , Germany
Local Institution - 0026
Löwenstein, , Germany
Local Institution - 0025
Wiesbaden, , Germany
Local Institution - 0030
Athens, , Greece
Local Institution - 0031
N. Faliro, , Greece
Local Institution - 0032
Thessaloniki, , Greece
Local Institution - 0013
Gyöngyös - Mátraháza, Heves County, Hungary
Local Institution - 0014
Budapest, , Hungary
Local Institution - 0054
Milan, Lombardy, Italy
Ospedale Policlinico San Martino
Genova, , Italy
IRST Meldola
Meldola, , Italy
AOU della Campania Luigi Vanvitelli
Napoli, , Italy
Local Institution
Napoli, , Italy
Ospedale Degli Infermi
Rimini, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Azienda Ospedaliera Santa Maria Terni
Terni, , Italy
Local Institution - 0019
Monterrey, NL, , Mexico
Local Institution - 0045
Groningen, , Netherlands
Local Institution - 0035
Rotterdam, , Netherlands
Local Institution - 0015
Bydgoszcz, , Poland
Local Institution - 0068
Sucha Beskidzka, , Poland
Local Institution - 0016
Warsaw, , Poland
Local Institution - 0128
Bucharest, , Romania
Local Institution - 0119
Craiova, , Romania
Local Institution - 0120
Romania, , Romania
Local Institution - 0022
Moscow, , Russia
Local Institution - 0021
Moscow, , Russia
Local Institution - 0020
Saint Petersburg, , Russia
Local Institution - 0061
A Coruña, , Spain
Local Institution - 0060
Barcelona, , Spain
Local Institution - 0062
Jaén, , Spain
Local Institution - 0065
Madrid, , Spain
Local Institution - 0064
Majadahonda - Madrid, , Spain
Local Institution - 0063
Seville, , Spain
Local Institution - 0059
Valencia, , Spain
Local Institution - 0112
Zaragoza, , Spain
Local Institution - 0048
Basel, , Switzerland
Local Institution - 0046
Zurich, , Switzerland
Local Institution - 0104
Antalya, , Turkey (Türkiye)
Local Institution - 0041
London, Greater London, United Kingdom
Local Institution - 0039
Leicester, Leicestershire, United Kingdom
Local Institution - 0040
Edinburgh, Midlothian, United Kingdom
Local Institution - 0042
Metropolitan Borough of Wirral, , United Kingdom
Local Institution - 0043
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Ready NE, Audigier-Valette C, Goldman JW, Felip E, Ciuleanu TE, Rosario Garcia Campelo M, Jao K, Barlesi F, Bordenave S, Rijavec E, Urban L, Aucoin JS, Zannori C, Vermaelen K, Aren Frontera O, Curioni Fontecedro A, Sanchez-Gastaldo A, Juan-Vidal O, Linardou H, Poddubskaya E, Spigel DR, Ahmed S, Maio M, Li S, Chang H, Fiore J, Acevedo A, Paz-Ares L. First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817. J Immunother Cancer. 2023 Feb;11(2):e006127. doi: 10.1136/jitc-2022-006127.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-002621-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-817
Identifier Type: -
Identifier Source: org_study_id
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