This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Motolimod
IV Nivolumab
Local Institution - 112
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Boston University
Boston, Massachusetts, United States
Local Institution - 116
Boston, Massachusetts, United States
Local Institution - 102
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Local Institution - 101
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
...and 2 more locations
Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery
Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment.
Time frame: Screening through Study Day 52
Number of Patients With adverse events that lead to delay in resection
Study will evaluate the number of patients who experience adverse events that lead to a significant delay in surgical resection.
Time frame: Screening through Study Day 52
Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod
Subject will be monitored for AEs both during treatment and for a specified period after last dose of study treatment. AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: Up to approximately 112 days
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