Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT02823574
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
425 participants
INTERVENTIONAL
2016-11-08
2022-04-21
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
DOUBLE
Study Groups
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Nivolumab and Ipilimumab
Specified dose on specified days
Nivolumab
Ipilimumab
Nivolumab and Ipilimumab-placebo
Specified dose on specified days
Nivolumab
Placebo
Interventions
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Nivolumab
Ipilimumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Widespread (metastatic) disease, or returned after previous treatment (recurrent)
* Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV \[Human Papilloma Virus (oropharynx only)\]
* Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)
Exclusion Criteria
* Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
* Any non-squamous subtype
* Active autoimmune disease
* Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
* Previous treatment with checkpoint inhibitor drugs
* Active CNS metastases or carcinomatous meningitis
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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University of Arizona Cancer Center
Tucson, Arizona, United States
Local Institution - 0034
Duarte, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Ucla Department Of Medicine
Los Angeles, California, United States
Local Institution - 0098
Redondo Beach, California, United States
Local Institution - 0004
Sacramento, California, United States
Local Institution - 0072
San Francisco, California, United States
Local Institution - 0097
San Luis Obispo, California, United States
Central Coast Med Oncology
Santa Maria, California, United States
Local Institution - 0101
New Haven, Connecticut, United States
Local Institution - 0007
Tampa, Florida, United States
Local Institution - 0010
Atlanta, Georgia, United States
Local Institution - 0015
Decatur, Georgia, United States
Local Institution - 0087
Chicago, Illinois, United States
Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana, United States
Local Institution - 0005
Louisville, Kentucky, United States
Oncology Associated Of Western Kentucky
Paducah, Kentucky, United States
Local Institution - 0001
Boston, Massachusetts, United States
Local Institution - 0071
Boston, Massachusetts, United States
Local Institution - 0042
Rochester, Minnesota, United States
Mission Hospital, Inc
Asheville, North Carolina, United States
Local Institution - 0103
Cincinnati, Ohio, United States
Local Institution - 0070
Cleveland, Ohio, United States
Local Institution - 0008
Portland, Oregon, United States
Local Institution - 0006
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation
Sayre, Pennsylvania, United States
Local Institution - 0102
Dallas, Texas, United States
Local Institution - 0038
Seattle, Washington, United States
Local Institution - 0121
Pergamino, Buenos Aires, Argentina
Local Institution - 0111
Buenos Aires, , Argentina
Local Institution - 0023
Ghent, , Belgium
Local Institution - 0074
Sint-Niklaas, , Belgium
Local Institution - 0053
Yvoir, , Belgium
Local Institution - 0046
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0124
Ipatinga, Minas Gerais, Brazil
Local Institution - 0047
Curitiba, Paraná, Brazil
Local Institution - 0125
Caxias do Sul, Rio Grande do Sul, Brazil
Local Institution - 0051
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0052
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0045
Barretos, São Paulo, Brazil
Local Institution - 0123
Santo André, São Paulo, Brazil
Local Institution - 0048
São José do Rio Preto, São Paulo, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution - 0049
São Paulo, , Brazil
Local Institution - 0050
São Paulo, , Brazil
Local Institution - 0013
Edmonton, Alberta, Canada
Local Institution - 0056
Ottawa, Ontario, Canada
Local Institution - 0012
Toronto, Ontario, Canada
Local Institution - 0016
Montreal, Quebec, Canada
Local Institution - 0014
Québec, Quebec, Canada
Local Institution - 0115
Santiago, Santiago Metropolitan, Chile
Local Institution - 0022
Brno, , Czechia
Local Institution - 0020
Hradec Králové, , Czechia
Local Institution - 0021
Olomouc, , Czechia
Local Institution - 0069
Helsinki, , Finland
Local Institution - 0032
Amiens, , France
Local Institution - 0120
Bordeaux, , France
Local Institution - 0073
Clermont-Ferrand, , France
Local Institution - 0089
Clichy, , France
Local Institution - 0029
Lyon, , France
Local Institution - 0075
Marseille, , France
Local Institution - 0079
Nice, , France
Local Institution - 0030
Rennes, , France
Local Institution - 0088
Villejuif, , France
Local Institution - 0026
Dublin, Dublin, Ireland
Local Institution
Milan, , Italy
Local Institution - 0119
Napoli, , Italy
Local Institution - 0090
Mérida, Yucatán, Mexico
Local Institution - 0107
Mérida, Yucatán, Mexico
Local Institution - 0108
Oaxaca City, , Mexico
Local Institution - 0068
Amsterdam, , Netherlands
Local Institution - 0028
Amsterdam, , Netherlands
Local Institution - 0027
Groningen, , Netherlands
Local Institution - 0065
Bergen, , Norway
Local Institution - 0064
Oslo, , Norway
Local Institution - 0055
Bucharest, , Romania
Local Institution - 0054
Cluj-Napoca, , Romania
Local Institution - 0033
Craiova, , Romania
Local Institution - 0060
Iași, , Romania
Local Institution - 0059
Suceava, , Romania
Local Institution - 0031
Moscow, , Russia
Local Institution - 0092
Ryazan, , Russia
Local Institution
Port Elizabeth, Eastern Cape, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution - 0017
Sandton, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution - 0040
A Coruña, , Spain
Local Institution - 0116
Barcelona, , Spain
Local Institution - 0039
Barcelona, , Spain
Local Institution - 0077
Madrid, , Spain
Local Institution - 0076
Marbella, , Spain
Local Institution - 0041
San Sabastian Gipuzkoa, , Spain
Local Institution - 0067
Gothenburg, , Sweden
Local Institution - 0037
Lund, , Sweden
Local Institution - 0035
Stockholm, , Sweden
Local Institution - 0063
Adana, , Turkey (Türkiye)
Local Institution - 0066
Antalya, , Turkey (Türkiye)
Local Institution - 0062
Izmir, , Turkey (Türkiye)
Local Institution - 0110
Aberdeen, Aberdeenshire, United Kingdom
Local Institution - 0086
London, Greater London, United Kingdom
Local Institution - 0083
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Local Institution - 0081
Sutton, Surrey, United Kingdom
Local Institution - 0114
Cardiff, , United Kingdom
Local Institution - 0084
Glasgow, , United Kingdom
Local Institution - 0082
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147.
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
FDA Safety Alerts and Recalls
Other Identifiers
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2016-001645-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-714
Identifier Type: -
Identifier Source: org_study_id
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