Clinical Trial

CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs

Recruiting Phase 2
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Summary
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 HPV-16 associated head and neck squamous cell carcinoma (HNSCC).
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-12
Trial Details
NCT Number NCT07172256
Lead Sponsor Yale University
Collaborators: Cue Biopharma, National Cancer Institute (NCI)
Conditions Head and Neck Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, New Diagnosis Tumor, Locally Advanced
Enrollment 30 participants
Start Date 2026-05-07
Primary Completion 2031-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-30