Condition: Oropharyngeal Squamous Cell Carcinoma · Sponsor: Washington University School of Medicine
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.
This description comes directly from the study's public registry record.
Jesse Zaretsky, M.D. · 314-747-8244 · jzaretsky@wustl.edu
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| Washington University School of Medicine | St Louis, Missouri, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04852328