Is NCT04722523 recruiting in Harrison, NY?

Yes, NCT04722523 is currently recruiting participants at its Harrison, NY location. This head and neck cancer clinical trial is actively enrolling qualified participants.

How do I join the head and neck cancer clinical trial in Harrison?

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

Is participation in this Harrison 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.

Head and Neck Cancer Clinical Trial in Harrison, NY

About This Head and Neck Cancer Study in Harrison

The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx

Clinical stage T1, N2-3; T2, N1-3, T3/T4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET/CT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +/- chemotherapy. ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy.

Disease must be amenable to surgical resection.

The patient must be a surgical candidate.

Hemoglobin \> 9.0 g/dL

Absolute neutrophil count (ANC) \>1.5 x 10\^9/L

Platelet count \>100 x 10\^9/L

Serum creatinine \<1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) \>30 mL/min

Adequate hepatic function:

Total bilirubin \<1.5 x upper limit of normal ULN)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \< 3 x ULN

Alkaline phosphatase (ALP) \<2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin \<3x ULN. Upper central must be documented appropriately as past medical history.

Men and woman \>18 years old

Eastern cooperative oncology group performance status \< 1

Exclusion Criteria

Prior radiation and systemic therapy for a head and neck cancer.

Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate.

Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years. Exceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted.

Conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study.

Receipt of live attenuated vaccine within 30 days prior initiating treatment on study.

Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.

Any infection requiring hospitalization and/or intravenous antibiotic therapy within 2 weeks of the start of treatment.

Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.

Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection monitoring will be performed per local standards

Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months be on the last dose of Cemiplimab.

Patients were HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.

History of immune-related pneumonitis with the last 5 years.

History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of leuko-corticoids to assist with management.

Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.

Patients with a history of solid organ transplant (exception: corneal transplant)

Any medical comorbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that in the opinion of the investigator renders the patient unsuitable for participation in a clinical trial due to high safety risks.

Women with a positive serum or urine beta-hCG pregnancy test at screening/baseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible.

Breast-feeding women

Women of childbearing potential who are sexually active and aren't willing to practice highly effective contraception prior to the first dose of Cemiplimab, during the study, and for at least 180 days after the last dose. Highly effective contraceptive measures include:

Stable use of combined estrogen and progesterone containing hormonal contraception or progesterone and-only hormonal contraception associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening

Intrauterine device; intrauterine hormone-releasing system

Bilateral tubal ligation

Vasectomized partner and/or

Sexual abstinence

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 Harrison?

Yes, this clinical trial (NCT04722523) has an active research site in Harrison, NY 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.

Head and Neck Cancer Treatment Options in Harrison, NY

If you're searching for head and neck cancer treatment options in Harrison, NY, this clinical trial (NCT04722523) 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 Harrison research site is actively enrolling participants for this clinical trial. You'll receive care from experienced head and neck cancer 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 head and neck cancer clinical trials near you to find additional studies recruiting in your area.

Head and Neck Cancer Clinical Trial in Harrison, NY

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