Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a known primary site, but is suspected to be oropharynx based on clinical factors. * Stage I-III (AJCC 8th Edition) \[except clinical stages T1N0 and T2N0, which are excluded from enrollment\]. * A candidate for standard of care therapy (either surgery followed by adjuvant therapy OR def-CRT), based on treating physician decision. * HLA-A\*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory. * Tumors must test positive for HPV16 by PCR (performed on tumor) or ISH (performed in tumor) and p16INK4A expression (\>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory. * Have archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion of sufficient size and quality for eligibility determination. * At least 18 years of age. * ECOG performance status ≤ 1. * Normal bone marrow and organ function as defined below: * Platelets ≥ 100,000/mcl * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1,500/mcl * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Total bilirubin ≤ 1.5 x IULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin (total and direct) is within normal limits * Creatinine \< 1.5 mg/dL, or calculated or measured creatinine clearance …