Status: Recruiting
CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs
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).
Participants needed: 30
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: May 13, 2026Locations: 1
Eligibility criteria
Participants must have histologically or cytologically confirmed new diagnosis o... [+20]
Has distant metastases or radiographically detectable (even if asymptomatic and/... [+38]