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New treatment option for Head and Neck Cancer
Official title A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer
ClinicalTrials.gov ID: NCT04722523
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral...
- 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...
- Disease must be amenable to surgical resection.
- The patient must be a surgical candidate.
- Hemoglobin \> 9.0 g/dL
You likely can't join if
- 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...
- Conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressant medications...
- Receipt of live attenuated vaccine within 30 days prior initiating treatment on study.
- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
See the full eligibility 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...
- 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 \ 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Intrauterine device; intrauterine hormone-releasing system
- Bilateral tubal ligation
- Vasectomized partner and/or
- Sexual abstinence
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.