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 not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rak nabłonka płaskonabłonkowego gardła lub górnych węzłów chłonnych szyi
- •Zaawansowana choroba (stadium I-III, z wyjątkiem T1N0 i T2N0)
- •Kandydat do standardowego leczenia (operacja lub chemioradioterapia)
- •Posiada określony typ genetyczny HLA-A*0201
- •Nowotwór pozytywny na HPV16 i ekspresję p16
- •Dostępna próbka tkanki guza do badań
- •Co najmniej 18 lat
- •Prawidłowa funkcja szpiku kostnego i narządów wewnętrznych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Washington University School of Medicine
St Louis, United States
Trial contact
Jesse Zaretsky, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/21/2026.
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