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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:May 1, 2014
End Date:October 27, 2020

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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)

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.


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
We found this trial at
17
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
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Berazategui, Buenos Aires
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Columbus, OH
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Durham, North Carolina 27710
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Houston, Texas 77030
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Metairie, Louisiana 70006
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Nashville, Tennessee 37232
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Pittsburgh, Pennsylvania 15232
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Salt Lake City, Utah 84112
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Tampa, Florida 33612
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