Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
Conditions
Colorectal Cancer - Head and Neck Cancer
Conditions: official terms
Colorectal Neoplasms - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Urelumab Type: Biological
Name: Cetuximab Type: Biological
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Stanford University
Stanford, California, United States
Status: Recruiting
Contact: A. Dimitrios Colevas, Site 0007 - 650-723-1367
University Of Chicago
Chicago, Illinois, United States
Status: Recruiting
Contact: Manish Sharma, Site 0001 - 773-834-0312
Johns Hopkins University
Baltimore, Maryland, United States
Status: Recruiting
Contact: Dung Le, Site 0002 - 443-287-0002
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Patrick Ott, Site 0004 - 617-632-6287
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Patrick Ott, Site 0009 - 617-726-0250
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Patrick Ott, Site 0008 - 617-555-1212
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Neil Segal, Site 0005 - 646-888-4187
Providence Oncology & Hematology Care Eastside
Portland, Oregon, United States
Status: Recruiting
Contact: Rom Leidner, Site 0006 - 503-215-2613
Upmc Cancer Center
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Robert Ferris, Site 0003 - 412-623-8963
Start Date
April 2014
Completion Date
January 2017
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page