Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

NCT02105636 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-1412013-003622-86
• Study Type: interventional
• Target: 361
• Locations: 15 countries
• Sites: 64

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.

  From date of randomization to date of death (Up to approximately 18 months)

Secondary Outcomes (2)

• Investigator-Assessed Progression-Free Survival (PFS)

  From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)

• Investigator-Assessed Objective Response Rate (ORR)

  From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)

Study Arms (2)

Arm A: Nivolumab

EXPERIMENTAL

Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression

Drug: Nivolumab

Arm B: Cetuximab/Methotrexate/Docetaxel

ACTIVE COMPARATOR

Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression OR Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression OR Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression

Drug: Cetuximab; Drug: Methotrexate; Drug: Docetaxel

Interventions

Nivolumab DRUG

Also known as: BMS-936558

Arm A: Nivolumab

Cetuximab DRUG

Arm B: Cetuximab/Methotrexate/Docetaxel

Methotrexate DRUG

Arm B: Cetuximab/Methotrexate/Docetaxel

Docetaxel DRUG

Arm B: Cetuximab/Methotrexate/Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (64)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Local Institution - 0001

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0002

Chicago, Illinois, 60637, United States

Location

Local Institution - 0004

Metairie, Louisiana, 70006, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Dumc

Durham, North Carolina, 27710, United States

Location

Local Institution - 0012

Columbus, Ohio, 43210, United States

Location

Local Institution - 0007

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

Univ Of Tx. Md Anderson

Hoston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 0031

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0015

Berazategui, Buenos Aires, 1880, Argentina

Location

Local Institution - 0013

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0014

Córdoba, 5000, Argentina

Location

Local Institution - 0054

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0055

São Paulo, 01321-001, Brazil

Location

Local Institution - 0038

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0045

London, Ontario, N6A 4L6, Canada

Location

Local Institution

Lyon, 69373, France

Location

Local Institution

Nice, 06189, France

Location

Local Institution

Villejuif, 94805, France

Location

Local Institution - 0047

Berlin, 12200, Germany

Location

Local Institution - 0049

Bonn, 53127, Germany

Location

Local Institution - 0048

Essen, 45122, Germany

Location

Local Institution - 0052

Hamburg, 20246, Germany

Location

Local Institution - 0046

Hanover, 30625, Germany

Location

Local Institution - 0050

Würzburg, 97070, Germany

Location

Local Institution

Hong Kong, Hong Kong

Location

Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori

Meldola, FC, 47014, Italy

Location

Local Institution

Milan, MI, 20133, Italy

Location

Local Institution

Torino, TO, 10126, Italy

Location

Local Institution

Milan, 20142, Italy

Location

Local Institution

Napoli, 80131, Italy

Location

Local Institution

Padua, 35128, Italy

Location

Local Institution - 0056

Nagoya, Aichi-ken, 4648681, Japan

Location

Local Institution - 0060

Kashiwa, Chiba, 2778577, Japan

Location

Local Institution - 0062

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0058

Kobe, Hyōgo, 650-0017, Japan

Location

Local Institution - 0063

Takatsuki, Osaka, 5698686, Japan

Location

Local Institution - 0059

Sunto-gun, Shizuoka, 4118777, Japan

Location

Local Institution - 0057

Akashi, Hyogo, 673-8558, Japan

Location

Local Institution - 0061

Tokyo, 135-8550, Japan

Location

Local Institution

Amsterdam, 1081 HV, Netherlands

Location

Local Institution

Groningen, 9713 AP, Netherlands

Location

Local Institution

Leiden, 2333 ZA, Netherlands

Location

Local Institution - 0067

Seoul, 135-710, South Korea

Location

Local Institution - 0066

Seoul, 137-701, South Korea

Location

Local Institution - 0032

Barcelona, 08035, Spain

Location

Local Institution - 0035

Barcelona, 08036, Spain

Location

Local Institution - 0034

Madrid, 28041, Spain

Location

Local Institution - 0033

Valencia, 46010, Spain

Location

Local Institution - 0051

Zurich, 8091, Switzerland

Location

Local Institution - 0065

Tainan, 704, Taiwan

Location

Local Institution - 0064

Taipei, 100, Taiwan

Location

Local Institution

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Local Institution

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution

Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

Location

Local Institution

Surrey, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 32583557 DERIVED

• 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.

  PMID: 31422216 DERIVED

• 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.

  PMID: 30972702 DERIVED

• 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.

  PMID: 30944020 DERIVED

• 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.

  PMID: 29884413 DERIVED

• 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.

  PMID: 28939066 DERIVED

• 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.

  PMID: 28651929 DERIVED

• 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.

  PMID: 27718784 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Nivolumab; Cetuximab; Methotrexate; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 7, 2014
• Study Start: May 29, 2014
• Primary Completion: November 6, 2015
• Study Completion: September 10, 2021
• Last Updated: October 5, 2022
• Results First Posted: January 11, 2017

Record last verified: 2022-08

Locations

ES (4); HK (1); AR (3); TW (2); DE (6); GB (5); CH (1); JP (8); KR (2); BR (3); NL (3); IT (6); US (15); CA (2); FR (3)