Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bristol-Myers Squibb


  • Biological: Urelumab
  • Biological: Cetuximab


Phase 1


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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

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting