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

Completed · Phase 3

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID

NCT02105636

Run by

Bristol-Myers Squibb

People needed

361

Starts

2014-05-29

Expected to finish

2021-09-10

Last updated by the study team

2022-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Local Institution - 0001 — Atlanta, Georgia, United States
• Local Institution - 0002 — Chicago, Illinois, United States
• Local Institution - 0004 — Metairie, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University Of Michigan — Ann Arbor, Michigan, United States
• Dumc — Durham, North Carolina, United States
• Local Institution - 0012 — Columbus, Ohio, United States
• Local Institution - 0007 — Pittsburgh, Pennsylvania, United States
• Vanderbilt Cancer Clinic — Nashville, Tennessee, United States
• Univ Of Tx. Md Anderson — Hoston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Local Institution - 0031 — Milwaukee, Wisconsin, United States
• Local Institution - 0015 — Berazategui, Buenos Aires, Argentina
• Local Institution - 0013 — San Miguel de Tucumán, Tucumán Province, Argentina
• Local Institution - 0014 — Córdoba, Argentina
• Local Institution - 0054 — Ijuí, Rio Grande do Sul, Brazil
• Local Institution — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0055 — São Paulo, Brazil
• Local Institution - 0038 — Vancouver, British Columbia, Canada
• Local Institution - 0045 — London, Ontario, Canada
• Local Institution — Lyon, France
• Local Institution — Nice, France
• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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