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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer; Colorectal Cancer

Treatments: Biological: Cetuximab; Biological: Urelumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02110082

CA186-018

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Cohort 1: Urelumab + Cetuximab

Experimental group

Description:

Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion

Treatment:

Biological: Urelumab

Biological: Cetuximab

Cohort 2: Urelumab + Cetuximab

Experimental group

Description:

Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion

Treatment:

Biological: Urelumab

Biological: Cetuximab