A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Massachusetts General Hospital /ID# 207392
Boston, Massachusetts, United States
University of Michigan /ID# 210181
Ann Arbor, Michigan, United States
MD Anderson Cancer Center /ID# 208749
Houston, Texas, United States
Changes in Gene Expression
The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.
Time frame: Baseline (before initiation of drug treatment) and after surgical resection (up to 120 days after study drug administration)
Maximum Serum Concentration (Cmax) of Study Drug
Maximum Serum Concentration (Cmax) of study drug
Time frame: Up to approximately 120 days
Time to Maximum Plasma Concentration (Tmax) of Study Drug
Time to Maximum Plasma Concentration (Tmax) of study drug
Time frame: Up to approximately 120 days
Area Under the Plasma Concentration-time Curve of Study Drug in Plasma
Area Under the Plasma Concentration-time Curve (AUC) of study drug in plasma
Time frame: Up to approximately 120 days
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intratumoral injection