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

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