Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
Trial ID or NCT#
Status
Purpose
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.
Official Title
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
Eligibility 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
- * 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
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov