Phase 2 Study of CUE-101 Alone and With Pembrolizumab as Pre-Surgery Treatment for Adults with New Locally Advanced HPV-16 Positive Head and Neck Cancer

What this Trial Is About

Researchers are studying a phase 2 clinical trial to evaluate the safety, tolerability, and effectiveness of CUE-101 alone and combined with pembrolizumab as pre-surgical treatment for adults newly diagnosed with locally advanced HPV-16 positive head and neck squamous cell carcinoma. Participants must have the HLA-A*0201 genotype and have not received prior treatment for this cancer. The study is randomized and open-label with three groups to compare different treatments before surgery. Participants will receive either CUE-101 alone, pembrolizumab alone, or both drugs together. CUE-101 is given by intravenous infusion at 4 mgkg on Day 1 and Day 21. Pembrolizumab is given by intravenous infusion at 200 mg on the same days. For combination therapy, pembrolizumab is given first, followed by CUE-101. After completing the neoadjuvant therapy, participants will undergo definitive surgical removal of the tumor. During the study, participants will have blood tests to measure HPV-16 specific immune cells, safety and tolerability assessments, imaging scans to evaluate tumor response, and pathological evaluations at surgery. The study will monitor participants up to 30 days after treatment for safety. The total duration covers treatment before surgery and evaluation at surgery, with ongoing follow-up to assess outcomes. The trial is sponsored by Yale University and is expected to complete by February 2031.

CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs