Is NCT06005324 recruiting in Chicago, IL?

Yes, NCT06005324 is currently recruiting participants at its Chicago, IL location. This hpv-negative squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HPV-Negative Squamous Cell Carcinoma Clinical Trial in Chicago, IL

Q: How do I join the hpv-negative squamous cell carcinoma clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Who Can Participate

Inclusion Criteria

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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT06005324) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HPV-Negative Squamous Cell Carcinoma Treatment Options in Chicago, IL

If you're searching for hpv-negative squamous cell carcinoma treatment options in Chicago, IL, this clinical trial (NCT06005324) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hpv-negative squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hpv-negative squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

HPV-Negative Squamous Cell Carcinoma Clinical Trial in Chicago, IL

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