Personalized Treatment for HPV-Negative Head and Neck Cancer
This study is looking at new ways to treat locally advanced head and neck cancer that is HPV-negative (meaning it's not caused by the human papillomavirus). Researchers want to see if blood tests can help personalize your treatment. You might receive a combination of chemotherapy drugs like Paclitaxel, Carboplatin, and Cetuximab, followed by either standard or low-dose radiation. To join, you must have stage III or IV HPV-negative squamous cell carcinoma (a type of cancer) of the head and neck, and be at least 18 years old. The study aims to see how many participants complete treatment and provide blood samples, and if blood test results can predict how well the treatment works. The current recruitment status is unclear, and the study plans to enroll 36 participants.
- Study design
- This is an interventional study with a planned enrollment of 36 participants. The study does not specify a phase.
- What's involved
- You will receive induction chemotherapy and then radiation. Blood draws will be required, with the primary endpoints measured at the end of the 9-week treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at the end of the 9-week treatment period. Further follow-up is not specified.
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NCT06005324
Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of ChicagoInvestigator-initiated
~36 participants
Updated 2025-06-08 on ClinicalTrials.gov
What's tested:PaclitaxelCarboplatinCetuximabStandard Dose RadiationLow Dose RadiationCisplatin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants that complete study treatment and provide all required research blood draws.
Measured over To be measured at end of treatment period (9 weeks)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Ari Rosenberg, MD · PRINCIPAL_INVESTIGATOR · University of Chicago
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
Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.
Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.
If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
Patients must be at least 18 years of age.
Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.
No previous radiation or chemotherapy for a head and neck cancer.
No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) No surgical procedures or core-needle or excisional biopsies will occur after baseline scans are performed and measurable lesions are identified. Fine-needle aspiration can be performed (i.e., to confirm extent of baseline lymph node involvement) following discussion with PI if not performed on a target lesion.
Performance status 0-1
Normal Organ Function
Leukocytes ≥ 3000/mm3
Platelets ≥ 100,000/mm3
Absolute neutrophil count ≥ 1,500
Hemoglobin ≥ 9.0 gm/dL
Aspartate Aminotransferase (AST) ≤ 2.5x upper limit of normal
Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal
Alkaline phosphatase ≤ 2.5x upper limit of normal
Albumin \> 2.9 gm/dL
Total bilirubin ≤ 1.5 mg/dL
Creatinine clearance (CrCl) \> 45 mL/min, normal within 2 weeks prior to start of treatment (Of note, the standard Cockcroft and Gault formula must be used to calculate CrCl for enrollment or dosing)
Patients must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
Women must not be breastfeeding
Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 months after completing chemoradiation or receiving the last dose of chemoradiation, whichever occurs latest.
Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 months after completing chemoradiation or receiving the last dose of chemoradiation, whichever occurs latest.
Exclusion
Unequivocal demonstration of distant metastatic disease (M1 disease).
Unidentifiable primary site.
Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).
Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
Patients receiving other investigational agents.
Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Known history of active tuberculosis (Bacillus Tuberculosis infection).
Hypersensitivity to cetuximab or any other drug used in this protocol.
Prior systemic anti-cancer treatment within the last 8 weeks.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment.
Has a history of HIV.
Has known active Hepatitis B or Hepatitis C. If eradicated, patient is eligible.
Has received a live vaccine within 28 days of planned start of study therapy.
What this trial measures
- Percentage of participants that complete study treatment and provide all required research blood draws.To be measured at end of treatment period (9 weeks)
- Determine if ctDNA levels is predicative of disease responseTo be measured at end of treatment period (9 weeks)
Researchers will look at amount of ctDNA in the blood to determine if it correlates to disease response based on imaging results per RECIST v1.1.