Combination Study of Urelumab and Cetuximab in Patients With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Head and Neck Cancer
NCT ID: NCT02110082
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2014-04-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Urelumab + Cetuximab
Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Urelumab
Cetuximab
Cohort 2: Urelumab + Cetuximab
Urelumab every 3 weeks with Cetuximab weekly through Intravenous infusion
Urelumab
Cetuximab
Interventions
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Urelumab
Cetuximab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Stanford University
Stanford, California, United States
University Of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Providence Oncology & Hematology Care Eastside
Portland, Oregon, United States
Upmc Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA186-018
Identifier Type: -
Identifier Source: org_study_id
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