NCT07172256

CUE-101with Pembrolizumab for LA-HPV+HNSCCs

A Pilot Study of CUE-101 in Combination With Pembrolizumab in Subjects With Newly Diagnosed, Locally Advanced HPV-16 Associated Head and Neck Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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, unresectable HPV-16 associated head and neck squamous cell carcinoma (HNSCC).

Detailed description

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, unresectable HPV-16 associated head and neck squamous cell carcinoma (HNSCC). CUE-101 monotherapy will be administered at 4 mg/kg IV on Days 1 and 21. Pembrolizumab monotherapy will be administered at 200 mg IV on Days 1 and 21. CUE-101 and pembrolizumab combination therapy will be administered by sequential infusion. Pembrolizumab will be administered at 200 mg IV followed by CUE-101 will be administered at 4 mg/kg IV on Days 1 and 21.

Conditions

• Head and Neck Squamous Cell Carcinoma
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• New Diagnosis Tumor
• Locally Advanced

Interventions

Type	Name	Description
DRUG	CUE-101	CUE-101 will be administered by IV infusion with a commercially available syringe pump or IV infusion pump over 60 minutes on Day 1 and Day 21 after all procedures and assessments are completed. It will be administered at a dosage level of 4 mg/kg x 2
DRUG	Pembrolizumab	Pembrolizumab will be administered on Day 1 and Day 21 after all procedures and assessments are completed according to the Study Calendar. Pembrolizumab will be administered as a dose of 200 mg using a 30-minute (- 5 min/+10 min) IV infusion.

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-02-01
• Completion: 2031-02-01
• First posted: 2025-09-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study