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
Trial Parameters
Brief Summary
This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A\*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.
Eligibility Criteria
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 dete