CUE-101with Pembrolizumab for LA-HPV+HNSCCs

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2030

Study Completion Date

November 30, 2030

Conditions
Head and Neck Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaNew Diagnosis TumorLocally Advanced
Interventions
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.

Trial Locations (1)

06510

Yale University, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cue Biopharma

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Yale University

OTHER