drugset / Trial / NCT07172256
CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs
Phase 2
Recruiting
30 enrolled
Yale University
Cue Biopharma · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2026-05-07
- Primary completion
- 2031-02
- Completion
- 2031-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CUE-101 | Protein / enzyme biologic | 4 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |