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).

Trial Details

NCT ID

NCT07172256

Phase

PHASE2

Sponsor

Yale University

Status

RECRUITING

Cancer Type

HPV Positive Head and Neck Cancer

Interventions

CUE-101
Pembrolizumab

Locations (sample)

New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell car…
Participants must be deemed unresectable by a head and neck surgeon for one or more of the following reasons:
Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS)
Risk of significant functional deficit with a surgical treatment approach

For full eligibility, visit ClinicalTrials.gov.

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