CUE-101 for HPV16-Positive Oropharyngeal Cancer Before Standard Treatment
This study is testing a drug called CUE-101 in people with locally advanced oropharyngeal squamous cell carcinoma (throat cancer) that is linked to HPV16. You would receive CUE-101 before your standard cancer treatment. The main goal is to see how safe CUE-101 is and if it causes any side effects. Researchers will also look for early signs of how well CUE-101 works by checking blood and tumor samples. To join, you must have HPV16-positive oropharyngeal cancer, be HLA-A*0201 positive (a specific genetic marker), and be between 18 and 99 years old. This study is currently unclear on its recruitment status and plans to enroll about 30 participants.
- Study design
- This is a Phase 2 interventional study, meaning it tests a new treatment. It will involve about 30 participants to assess the safety and early effectiveness of CUE-101.
- What's involved
- You would receive CUE-101 before your standard cancer treatment. Blood and tumor samples will be collected at the start and after CUE-101 administration.
- Compensation
- CUE-101 will be provided free of charge to the patient. Not stated in the trial record.
- Follow-up
- Researchers will monitor you for side effects from the start of treatment through 12 months after your standard cancer treatment is finished, which is estimated to be about 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04852328
Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~30 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:CUE-101
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment-related adverse events
Measured over From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
+7 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Jesse Zaretsky, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a known primary site, but is suspected to be oropharynx based on clinical factors.
Stage I-III (AJCC 8th Edition) \[except clinical stages T1N0 and T2N0, which are excluded from enrollment\].
A candidate for standard of care therapy (either surgery followed by adjuvant therapy OR def-CRT), based on treating physician decision.
HLA-A\*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory.
Tumors must test positive for HPV16 by PCR (performed on tumor) or ISH (performed in tumor) and p16INK4A expression (\>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory.
Have archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion of sufficient size and quality for eligibility determination.
At least 18 years of age.
ECOG performance status ≤ 1.
Normal bone marrow and organ function as defined below:
Platelets ≥ 100,000/mcl
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1,500/mcl
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Total bilirubin ≤ 1.5 x IULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin (total and direct) is within normal limits
Creatinine \< 1.5 mg/dL, or calculated or measured creatinine clearance \>30 mL/min by Cockcroft-Gault
Note: Screening laboratory tests may be repeated once within 7 days.
The effects of CUE-101 on the developing human fetus are unknown. For this reason and because novel Fc Fusion Protein agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 30 days after completion of the study.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion
History of prior allogeneic bone marrow, stem-cell or solid organ transplantation
Distant metastases.
Treatment with radiation therapy or systemic anti-cancer therapy prior to the initiation of study drug administration.
Treatment with corticosteroids (\>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration. Corticosteroids for topical, ophthalmic, inhaled, or nasal administration are allowed. Physiological replacement with hydrocortisone up to a maximum dose of 40 mg per day is allowed.
History of clinically significant cardiovascular disease including:
Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug
Clinically significant cardiac arrhythmias
Uncontrolled hypertension: systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg
Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug
QTc prolongation \> 480 msec
Congestive heart failure (New York Heart Association class III- IV)
Pericarditis/clinically significant pericardial effusion
Myocarditis
Clinically significant pulmonary compromise (eg, requirement for supplemental oxygen).
Clinically significant gastrointestinal (GI) disorders including history of:
GI perforation within 1 year prior to study drug administration;
GI bleeding within 3 months prior to the initiation of study drug;
Acute pancreatitis within 3 months prior to the initiation of study drug;
Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and/or the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study drug administration; and/or
Cirrhosis.
Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than 1 week prior to the initiation of study drug.
Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction. However, patients with treated hepatitis C in complete remission and off therapy for \> 1 year are eligible.
Second primary invasive malignancy that has not been in remission for greater than 2 years. Exceptions include: non-melanoma skin cancer; cervical carcinoma in situ; squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score \< 6); resected melanoma in situ; or favourable prognosis (\<10% relapse risk) thyroid cancer.
Prior treatment of the head and neck region with radiation therapy.
History of major surgery within 4 weeks prior to the initiation of study drug administration. A diagnostic needle or excisional biopsy is not considered major surgery.
Any serious underlying medical condition that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site.
Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-101.
Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. Vaccination for COVID-19 is allowed within one week prior to initiation of study drug administration.
Active or recent history of uncontrolled alcohol or other substance abuse within 3 months prior to the initiation of study drug administration.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.
What this trial measures
- Number of treatment-related adverse eventsFrom start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
- Number of adverse eventsFrom start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months
- Treatment-related delays in start of standard of care therapyFrom start of treatment through start of standard of care therapy (estimated to be 2 weeks)
-Defined as \>7 days of treatment-related delay from the planned date of surgery or initiation of definitive-chemoradiation therapy.
- Change in frequency of HPV16 E711-20-specific CD8+ T cells in peripheral blood samplesThrough 12 month follow-up
* Determined by IFN γ ELISpot for detection of HPV16 E711-20-specific T cells * Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
- Change in frequency of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytesThrough 12 month follow-up
* Determined by multiparameter flow cytometry * Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
- Change in frequency of HPV16 E711-20-specific CD8+ T cells in tumor samplesBaseline, day -2 or -1 before start of standard of care therapy
- Activation markers of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytesThrough 12 month follow-up
- Proliferative status of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytesThrough 12 month follow-up