Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2017
Start Date:April 8, 2014
End Date:December 14, 2016

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A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose
of Urelumab in combination with Cetuximab in patients with Advanced/Metastatic Colorectal
Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.


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

Inclusion Criteria:

- Subjects with advanced/metastatic Colorectal Cancer(CRC) who have failed or been
intolerant to both irinotecan- and oxaliplatin- based regimens

- Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck
(SCCHN) who are without options for curative treatment

- Subjects must have measurable disease per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 criteria

- Men and women 18 and older

- Women of childbearing potential (WOCBP) and men must use highly effective methods of
contraception

- Eastern Cooperative Oncology Group (ECOG) of 0 or 1

- Subjects must have a life expectancy of at least 3 months

Exclusion Criteria:

- Active or progressing brain metastases

- Other concomitant malignancies (with some exceptions per protocol)

- Nasopharyngeal carcinoma

- Active or history of autoimmune disease

- Positive test for Human Immunodeficiency Virus (HIV) 1&2 or known AIDS

- History of any hepatitis (A,B or C)

- Known current drug or alcohol abuse

- Active Tuberculosis (TB)

- Use of anti-cancer treatments within 28 days

- Prior therapy with anti-CD137 antibody

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
9
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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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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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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from
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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mi
from
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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mi
from
Boston, MA
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Pittsburgh, Pennsylvania 15232
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Pittsburgh, PA
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Portland, OR
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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