CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07172256
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CUE-101 — DRUG
    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
  • Pembrolizumab — DRUG
    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.

Study Details

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).

Key Dates

Start date
May 7, 2026
Status verified
May 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant CUE-101
    Neoadjuvant therapy followed by definitive surgical resection
  • Experimental: Neoadjuvant Pembro
    Pembrolizumab Neoadjuvant therapy followed by definitive surgical resection
  • Experimental: Neoadjuvant CUE-101 + Pembro
    CUE-101+Pembrolizumab as neoadjuvant therapy followed by definitive surgical resection

Primary Outcome Measure

Measurement of HPV-16 E711-20-Specific CD8+ T Cells in Peripheral Blood [ Time Frame: Baseline and perioperative/periprocedural ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Sara Pai, MD
[email protected]
203-836-0406
Sara Pai, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Yale University· New Haven, CT

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