Actively Recruiting
CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs
Led by Yale University · Updated on 2026-05-13
30
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
C
Cue Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a new diagnosis of locally advanced, non-metastatic head and neck squamous cell carcinoma of the oropharynx
- Tumor must be HPV-16 positive and express p16INK4A, confirmed by tissue testing
- Participants must have HLA-A*0201 genotype confirmed by genomic testing
- Must have measurable disease with at least one lesion meeting size requirements
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate organ and marrow function
- HIV-infected participants on effective therapy with undetectable viral load within 6 months are eligible
- Participants with chronic hepatitis B must have undetectable viral load on treatment
- Participants with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Participants with prior or concurrent malignancies are eligible if they do not interfere with study assessments
- Cardiac function must be New York Heart Association class 2B or better
- Males must agree to use effective contraception during treatment and 120 days after
- Females must not be pregnant or breastfeeding and must meet contraception requirements
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of distant metastases or central nervous system metastases
- Positive pregnancy test in women of childbearing potential
- Prior radiotherapy or systemic anticancer therapy for the current head and neck cancer
- Participation in another investigational study or device use within 4 weeks prior to study drug
- History of allergic reactions to components similar to study drugs
- History of autoimmune disease except certain mild or resolved conditions
- Prior allogeneic bone marrow, stem-cell, or organ transplantation
- Use of corticosteroids >10 mg prednisone or equivalent within 7 days prior to dosing
- Significant cardiovascular disease or uncontrolled hypertension
- Clinically significant pulmonary or gastrointestinal disorders
- Active infections requiring systemic treatment within 7 days prior to dosing
- Second primary invasive malignancy not in remission for over 2 years except certain exceptions
- Recent trauma or major surgery within 4 weeks prior to dosing
- Receipt of live vaccines within 30 days prior to dosing
- Grade >2 hearing loss, neuropathy, or bleeding due to cancer
- History or current pneumonitis requiring steroids
- Active or recent substance abuse within 1 year
- Uncontrolled illness or psychiatric/social issues limiting study compliance
- Study personnel or prisoners
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Sara Pai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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