Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT02741570
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
947 participants
INTERVENTIONAL
2016-10-05
2022-09-22
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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Nivolumab and Ipilimumab
Specified dose on specified days
Nivolumab
Ipilimumab
Extreme Regimen
Specified dose on specified days
Cetuximab/Erbitux
Cisplatin/Platinol
Carboplatin/Paraplatin
Fluorouracil/Adrucil
Interventions
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Nivolumab
Ipilimumab
Cetuximab/Erbitux
Cisplatin/Platinol
Carboplatin/Paraplatin
Fluorouracil/Adrucil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
* Measurable disease detected by imaging exam (CT or MRI).
* Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.
Exclusion Criteria
* No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
* Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
* Inadequate hematologic, renal or hepatic function.
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
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 - 0134
Tucson, Arizona, United States
Local Institution - 0135
Duarte, California, United States
Local Institution - 0005
Stanford, California, United States
Local Institution - 0028
Jacksonville, Florida, United States
Local Institution - 0008
Tampa, Florida, United States
Local Institution - 0111
Atlanta, Georgia, United States
Local Institution - 0006
Chicago, Illinois, United States
Local Institution - 0001
Boston, Massachusetts, United States
Local Institution - 0080
Boston, Massachusetts, United States
Local Institution - 0093
Boston, Massachusetts, United States
Local Institution - 0004
Ann Arbor, Michigan, United States
Local Institution - 0012
Charlotte, North Carolina, United States
Local Institution - 0007
Columbus, Ohio, United States
Local Institution - 0010
Langhorne, Pennsylvania, United States
Local Institution - 0015
Philadelphia, Pennsylvania, United States
Local Institution - 0013
Pittsburgh, Pennsylvania, United States
Local Institution - 0139
Dallas, Texas, United States
Local Institution - 0009
Houston, Texas, United States
Local Institution - 0014
Houston, Texas, United States
Local Institution - 0003
Charlottesville, Virginia, United States
Local Institution - 0011
Fairfax, Virginia, United States
Local Institution - 0125
Morgantown, West Virginia, United States
Local Institution - 0142
Blacktown, New South Wales, Australia
Local Institution - 0127
Darlinghurst, New South Wales, Australia
Local Institution - 0128
Gosford, New South Wales, Australia
Local Institution - 0019
St Leonards, New South Wales, Australia
Local Institution - 0077
Brisbane, Queensland, Australia
Local Institution - 0036
Douglas, Queensland, Australia
Local Institution - 0021
Elizabeth Vale, South Australia, Australia
Local Institution - 0022
Clayton, Victoria, Australia
Local Institution - 0131
Melbourne, Victoria, Australia
Local Institution - 0020
Nedlands, Western Australia, Australia
Local Institution - 0075
Linz, , Austria
Local Institution - 0071
Vienna, , Austria
Local Institution - 0148
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0121
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0122
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0120
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0117
Barretos, São Paulo, Brazil
Local Institution - 0123
Sao Jose de Rio Preto, São Paulo, Brazil
Local Institution - 0118
São Paulo, , Brazil
Local Institution - 0124
São Paulo, , Brazil
Local Institution - 0133
Amiens, Somme, France
Local Institution - 0094
Bordeaux, , France
Local Institution - 0140
La Tronche, , France
Local Institution - 0090
Lille, , France
Local Institution - 0138
Lyon, , France
Local Institution - 0054
Lyon, , France
Local Institution - 0126
Marseille, , France
Local Institution - 0055
Nice, , France
Local Institution - 0039
Paris, , France
Local Institution - 0088
Paris, , France
Local Institution
Paris, , France
Local Institution - 0089
Strasbourg, , France
Local Institution - 0040
Villejuif, , France
Local Institution - 0068
Bonn, , Germany
Local Institution - 0078
Freiburg im Breisgau, , Germany
Local Institution - 0067
Hamburg, , Germany
Local Institution - 0092
Hanover, , Germany
Local Institution - 0079
Heidelberg, , Germany
Local Institution - 0074
Leipzig, , Germany
Local Institution - 0070
Mainz, , Germany
Local Institution - 0065
München, , Germany
Local Institution - 0069
Ulm, , Germany
Local Institution - 0066
Würzburg, , Germany
Local Institution - 0018
Athens, , Greece
Local Institution - 0017
Nea Kifissia, , Greece
Local Institution - 0051
Thessaloniki, , Greece
Local Institution - 0147
Dublin, Dublin, Ireland
Local Institution - 0062
Haifa, , Israel
Local Institution - 0060
Jerusalem, , Israel
Local Institution - 0063
Petah Tikva, , Israel
Local Institution - 0061
Ramat Gan, , Israel
Local Institution - 0064
Tel Aviv, , Israel
Local Institution - 0042
Milan, MI, Italy
Local Institution - 0043
Torino, TO, Italy
Local Institution - 0044
Cuneo, , Italy
IRST Meldola
Meldola (FC), , Italy
Azienda Ospedaliera Universitaria Di Modena
Modena, , Italy
Aorn Dei Colli
Napoli, , Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, , Italy
Azienda Ospedaliera Di Perugia
Perugia, , Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Local Institution - 0106
Nagoya, Aichi-ken, Japan
Local Institution - 0100
Kashiwa, Chiba, Japan
Local Institution - 0113
Fukuoka, Fukuoka, Japan
Local Institution - 0105
Sapporo, Hokkaido, Japan
Local Institution - 0107
Akashi-shi, Hyōgo, Japan
Local Institution - 0102
Kobe, Hyōgo, Japan
Local Institution - 0152
Isehara, Kanagawa, Japan
Local Institution - 0150
Yokohama, Kanagawa, Japan
Local Institution - 0151
Natori-shi, Miyagi, Japan
Local Institution - 0108
Sendai, Miyagi, Japan
Local Institution - 0146
Osakasayaha, Osaka, Japan
Local Institution - 0099
Takatsuki-shi, Osaka, Japan
Local Institution - 0149
Kitaadachi-gun, Saitama, Japan
Local Institution - 0114
Sunto-gun, Shizuoka, Japan
Local Institution
Shimotsuke-shi, Tochigi, Japan
Local Institution - 0153
Bunkyo-ku, Tokyo, Japan
Local Institution - 0101
Chuo-ku, Tokyo, Japan
Local Institution - 0104
Koto-ku, Tokyo, Japan
Local Institution - 0109
Kita-gun, , Japan
Local Institution - 0032
León, Guanajuato, Mexico
Local Institution - 0034
Mexico City, Mexico City, Mexico
Local Institution - 0030
Mexico City, Mexico City, Mexico
Local Institution - 0031
Morelia, Michoacán, Mexico
Local Institution - 0033
Monterrey, Nuevo León, Mexico
Local Institution - 0035
Oaxaca City, , Mexico
Local Institution - 0037
Bydgoszcz, , Poland
Local Institution - 0023
Gdansk, , Poland
Local Institution - 0129
Gliwice, , Poland
Local Institution - 0026
Krakow, , Poland
Local Institution - 0025
Warsaw, , Poland
Local Institution - 0096
Gangnam-gu, , South Korea
Local Institution - 0110
Seoul, , South Korea
Local Institution - 0095
Seoul, , South Korea
Local Institution - 0083
Barcelona, , Spain
Local Institution - 0130
L'Hospitalet Del Llobregat, , Spain
Local Institution - 0085
Madrid, , Spain
Local Institution - 0082
Madrid, , Spain
Local Institution - 0084
Seville, , Spain
Local Institution - 0081
Valencia, , Spain
Local Institution - 0072
Basel, , Switzerland
Local Institution - 0073
Zurich, , Switzerland
Local Institution - 0097
Taichung, , Taiwan
Local Institution - 0098
Taipei, , Taiwan
Local Institution - 0049
Newcastle upon Tyne, Durham, United Kingdom
Local Institution - 0045
London, Greater London, United Kingdom
Local Institution - 0046
Manchester, Greater Manchester, United Kingdom
Local Institution - 0047
Southampton, Hampshire, United Kingdom
Local Institution - 0091
Sutton, Surrey, United Kingdom
Local Institution - 0050
Birmingham, West Midlands, United Kingdom
Local Institution - 0132
Sheffield, , United Kingdom
Countries
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References
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Haddad RI, Harrington K, Tahara M, Ferris RL, Gillison M, Fayette J, Daste A, Koralewski P, Zurawski B, Taberna M, Saba NF, Mak M, Kawecki A, Girotto G, Alvarez Avitia MA, Even C, Toledo JGR, Guminski A, Muller-Richter U, Kiyota N, Roberts M, Khan TA, Miller-Moslin K, Wei L, Argiris A. Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol. 2023 Apr 20;41(12):2166-2180. doi: 10.1200/JCO.22.00332. Epub 2022 Dec 6.
Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available.
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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2016-000725-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-651
Identifier Type: -
Identifier Source: org_study_id
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