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Lip, Oral Cavity and Pharynx, Phase II

A Pilot Study of CUE-101 in Combination With Pembrolizumab in Subjects With Newly Diagnosed, Locally Advanced HPV-16 Associated Head and Neck Cancer

What is the purpose of this trial?

This is a phase 2, pilot, randomized, open-label 3-arm study to assess the safety, tolerability, and efficacy of CUE-101 monotherapy, and CUE-101 in combination with pembrolizumab as neoadjuvant therapy in HLA-A*0201-positive treatment naive participants with locally advanced, unresectable HPV-16 associated head and neck squamous cell carcinoma (HNSCC).

Contact Information

For more information about this study, including how to volunteer, contact Sharon Huie

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  • Last Updated
    05/08/2026
  • Study IRB
    #2000036095