The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given prior to surgery in patients with advanced head and neck squamous cell carcinoma.
This phase Ib clinical trial uses MEDI6469 at various dose intervals prior to definitive surgical resection of patients with stage III and IV Oral Head and Neck Squamous Cell Carcinoma (OHNSCC) with the primary objective of determining the safety and feasibility of preoperative MEDI6469 administration. In addition, tumor tissue and peripheral blood will be obtained for exploratory immunologic end points including measurements of tumor infiltrating immune cell populations based on flow cytometry and immunohistochemistry as well as circulating immunological parameters that may correlate with changes induced by MEDI6469 administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Anti-OX40 antibody administration at 0.4 mg/kg IV x 3 doses given on Days 1, 3 or 4, and 5 or 6 of study
Surgical Resection of Tumor
Portland Providence Medical Center
Portland, Oregon, United States
Safety and feasibility of definitive surgical resection for locoregionally advanced OHNSCC following MEDI6469 administration
Patients will be seen in clinic 7 times over 55 days to identify any possible side effects or complications thought to be related to the study drug to help identify the optimal treatment schedule.
Time frame: 55 Days
Immunologic phenotypes of lymphocyte subsets
An uninvolved tumor-draining lymph node, primary tumor, and metastatic lymph nodes will be obtained during surgery, and peripheral blood will be collected 7 times over 55 days to identify the composition and immunologic phenotypes of lymphocyte subsets. This will also be compared to historical controls.
Time frame: 55 days
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