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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

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