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

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

Trial Details

NCT ID
NCT04852328
Phase
PHASE2
Sponsor
Washington University School of Medicine
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • CUE-101
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a kn…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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