Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therap
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 a
| Condition(s) | Oropharyngeal Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 a |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Washington University School of Medicine |
| Locations | St Louis, Missouri, United States |
| Start date | 2021-12-06 |
| NCT ID | NCT04852328 |
| Official listing | https://clinicaltrials.gov/study/NCT04852328 |