A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer - VTX-2337-HN-001
Updated: 29 January, 2021 | ClinicalTrials.gov
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Inclusion Criteria: - Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). - Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. - Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of the oral cavity, pharynx, or larynx - Macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery. - Subject consents to and has tumor accessible for tumor biopsy pre-treatment. - Subjects must have acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests. Exclusion Criteria: - Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study - Subject has unresectable or inoperable tumors - Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors - Subject has evidence of distant metastasis - Subject is a pregnant or nursing female. - Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C. - Subject has active autoimmune disease. - Subject has clinically significant ophthalmologic disease.