OncoMatch/Clinical Trials/NCT04852328
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
Is NCT04852328 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies CUE-101 for oropharyngeal squamous cell carcinoma.
Treatment: CUE-101 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HLA-A 0201
HLA-A*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory.
Required: HPV16 positive
Tumors must test positive for HPV16 by PCR (performed on tumor) or ISH (performed in tumor)
Required: CDKN2A p16INK4A overexpression (>70% staining in tumor cells)
p16INK4A expression (>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory.
Disease stage
Required: Stage I, II, III
Excluded: Stage T1N0, T2N0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Treatment with radiation therapy or systemic anti-cancer therapy prior to the initiation of study drug administration.
Cannot have received: systemic anti-cancer therapy
Treatment with radiation therapy or systemic anti-cancer therapy prior to the initiation of study drug administration.
Cannot have received: radiation therapy
Prior treatment of the head and neck region with radiation therapy.
Lab requirements
Blood counts
Platelets ≥ 100,000/mcl; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1,500/mcl
Kidney function
Creatinine < 1.5 mg/dL, or calculated or measured creatinine clearance >30 mL/min by Cockcroft-Gault
Liver function
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
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 >30 mL/min by Cockcroft-Gault
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
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