RecruitingPhase IIEN originalHead and neck cancerEarly / localized

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

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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

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/21/2026.

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