Clinical trial NCT02105636: Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Official title: An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2014-04-07
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
* Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
* Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases are not allowed
* Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
* Subjects with active, known or suspected autoimmune disease

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization to date of death (Up to approximately 18 months)
Secondary outcomes:
measure: Investigator-Assessed Progression-Free Survival (PFS)
timeFrame: From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
measure: Investigator-Assessed Objective Response Rate (ORR)
timeFrame: From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0001
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0002
state: Illinois
city: Metairie
country: United States
facility: Local Institution - 0004
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Durham
country: United States
facility: Dumc
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 0012
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0007
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Cancer Clinic
state: Tennessee
city: Hoston
country: United States
facility: Univ Of Tx. Md Anderson
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Milwaukee
country: United States
facility: Local Institution - 0031
state: Wisconsin
city: Berazategui
country: Argentina
facility: Local Institution - 0015
state: Buenos Aires
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution - 0013
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution - 0014
city: Ijui
country: Brazil
facility: Local Institution - 0054
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Local Institution - 0055
city: Vancouver
country: Canada
facility: Local Institution - 0038
state: British Columbia
city: London
country: Canada
facility: Local Institution - 0045
state: Ontario
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Nice Cedex 2
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution - 0047
city: Bonn
country: Germany
facility: Local Institution - 0049
city: Essen
country: Germany
facility: Local Institution - 0048
city: Hamburg
country: Germany
facility: Local Institution - 0052
city: Hannover
country: Germany
facility: Local Institution - 0046
city: Wuerzburg
country: Germany
facility: Local Institution - 0050
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Meldola
country: Italy
facility: Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
state: FC
city: Milano
country: Italy
facility: Local Institution
state: MI
city: Torino
country: Italy
facility: Local Institution
state: TO
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Nagoya
country: Japan
facility: Local Institution - 0056
state: Aichi
city: Kashiwa
country: Japan
facility: Local Institution - 0060
state: Chiba
city: Sapporo-shi
country: Japan
facility: Local Institution - 0062
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Local Institution - 0058
state: Hyogo
city: Takatsuki
country: Japan
facility: Local Institution - 0063
state: Osaka
city: Sunto-gun
country: Japan
facility: Local Institution - 0059
state: Shizuoka
city: Akashi, Hyogo
country: Japan
facility: Local Institution - 0057
city: Tokyo
country: Japan
facility: Local Institution - 0061
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0067
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0066
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution - 0032
city: Barcelona
country: Spain
facility: Local Institution - 0035
city: Madrid
country: Spain
facility: Local Institution - 0034
city: Valencia
country: Spain
facility: Local Institution - 0033
city: Zuerich
country: Switzerland
facility: Local Institution - 0051
city: Tainan
country: Taiwan
facility: Local Institution - 0065
city: Taipei
country: Taiwan
facility: Local Institution - 0064
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Wirral
country: United Kingdom
facility: Local Institution
state: Merseyside
city: Surrey
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Yen CJ, Kiyota N, Hanai N, Takahashi S, Yokota T, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Li WSK, Ferris RL, Gillison M, Endo T, Jayaprakash V, Tahara M. Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141). Head Neck. 2020 Oct;42(10):2852-2862. doi: 10.1002/hed.26331. Epub 2020 Jun 24.
citation: Saba NF, Blumenschein G Jr, Guigay J, Licitra L, Fayette J, Harrington KJ, Kiyota N, Gillison ML, Ferris RL, Jayaprakash V, Li L, Brossart P. Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age. Oral Oncol. 2019 Sep;96:7-14. doi: 10.1016/j.oraloncology.2019.06.017. Epub 2019 Jul 3.
citation: Cocks K, Contente M, Simpson S, DeRosa M, Taylor FC, Shaw JW. A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator's Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck. Pharmacoeconomics. 2019 Aug;37(8):1041-1047. doi: 10.1007/s40273-019-00798-1.
citation: Pai SI, Faivre S, Licitra L, Machiels JP, Vermorken JB, Bruzzi P, Gruenwald V, Giglio RE, Leemans CR, Seiwert TY, Soulieres D. Comparative analysis of the phase III clinical trials of anti-PD1 monotherapy in head and neck squamous cell carcinoma patients (CheckMate 141 and KEYNOTE 040). J Immunother Cancer. 2019 Apr 3;7(1):96. doi: 10.1186/s40425-019-0578-0.
citation: Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington KJ, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Docampo LCI, Haddad R, Rordorf T, Kiyota N, Tahara M, Lynch M, Jayaprakash V, Li L, Gillison ML. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol. 2018 Jun;81:45-51. doi: 10.1016/j.oraloncology.2018.04.008. Epub 2018 Apr 17.
citation: Kiyota N, Hasegawa Y, Takahashi S, Yokota T, Yen CJ, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Sum Kenneth Li W, Ferris RL, Gillison M, Namba Y, Monga M, Lynch M, Tahara M. A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator's choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141. Oral Oncol. 2017 Oct;73:138-146. doi: 10.1016/j.oraloncology.2017.07.023. Epub 2017 Sep 1.
citation: Harrington KJ, Ferris RL, Blumenschein G Jr, Colevas AD, Fayette J, Licitra L, Kasper S, Even C, Vokes EE, Worden F, Saba NF, Kiyota N, Haddad R, Tahara M, Grunwald V, Shaw JW, Monga M, Lynch M, Taylor F, DeRosa M, Morrissey L, Cocks K, Gillison ML, Guigay J. Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1104-1115. doi: 10.1016/S1470-2045(17)30421-7. Epub 2017 Jun 23.
citation: Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.