CUE-101with Pembrolizumab for LA-HPV+HNSCCs (NCT07172256) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CUE-101with Pembrolizumab for LA-HPV+HNSCCs
United States30 participantsStarted 2026-04
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS)
✓. Risk of significant functional deficit with a surgical treatment approach
✓. Other anatomical (such as retropharyngeal location of the carotid artery) or tumor characteristics that in the surgeon's judgment would be a contra-indication to a minimally invasive surgical approach.
✓. Not a woman of childbearing potential (WOCBP) as defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal or
✓. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
✓. Highly effective methods of contraception:
Exclusion criteria
✕. Vitiligo.
✕. Resolved childhood atopic dermatitis.
✕. Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
✕. Participants with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
✕. Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug.
What they're measuring
1
Measurement of HPV-16 E711-20-Specific CD8+ T Cells in Peripheral Blood
Timeframe: Baseline and perioperative/periprocedural