A Pilot Study of CUE-101 in Combination With Pembrolizumab in Subjects With Newly Diagnosed, Locally Advanced HPV-16 Associated Head and Neck Cancer
Yale University
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).
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.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oropharynx (cT1-4 N0-N3 M0) * Participants must be deemed unresectable by a head and neck surgeon for one or more of the following reasons: 1. Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS) 2. Risk of significant functional deficit with a surgical treatment approach 3. Other anatomical (such as retropharyngeal location of the carotid…
Interventions
- DrugCUE-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
- DrugPembrolizumab
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.
Location
- Yale UniversityNew Haven, Connecticut