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

Completed · Phase 1

Conditions studied: Colorectal Cancer, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02110082

Run by

Bristol-Myers Squibb

People needed

66

Starts

2014-04-01

Expected to finish

2016-12-01

Last updated by the study team

2017-04-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• University Of Chicago — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Providence Oncology & Hematology Care Eastside — Portland, Oregon, United States
• Upmc Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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