Actively Recruiting
Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
Led by University of Chicago · Updated on 2025-06-08
36
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.
CONDITIONS
Official Title
Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathologically confirmed locally advanced, non-metastatic, 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 6 unstained 5 micron slides or a new biopsy prior to enrollment.
- Patients must be at least 18 years of age.
- Measurable disease by RECIST 1.1 criteria.
- No previous radiation or chemotherapy for head and neck cancer.
- No complete surgical resection for head and neck cancer within 8 weeks of enrollment (biopsies allowed under conditions).
- Performance status 0-1.
- Normal organ function with specified blood counts and liver/kidney parameters.
- Signed informed consent.
- Women of childbearing potential must have a negative pregnancy test within 24 hours prior to starting study drug.
- Women must not be breastfeeding.
- Women of childbearing potential and sexually active men must agree to contraception during treatment and for 5 months after last dose.
You will not qualify if you...
- Presence of distant metastatic disease (M1).
- Unidentifiable primary tumor site.
- Medical illnesses that impair therapy tolerance or survival, including active infections, immunodeficiency, severe heart or lung conditions, or psychiatric/social issues limiting compliance.
- Prior surgical therapy beyond biopsies or organ-sparing procedures without residual measurable tumor.
- Participation in other investigational treatments.
- Immunodeficiency diagnosis or systemic steroid/immunosuppressive therapy within 7 days before treatment.
- History of active tuberculosis.
- Hypersensitivity to cetuximab or other protocol drugs.
- Prior systemic anti-cancer treatment within 8 weeks.
- Active additional malignancy requiring treatment, except certain skin cancers or in situ cervical cancer.
- History of HIV infection.
- Known active Hepatitis B or C (eradicated cases allowed).
- Receipt of live vaccine within 28 days before starting study therapy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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