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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Radiation Therapy and Pembrolizumab or Cisplatin in Treating Patients with Stage III / IV p16 Positive Head and Neck Squamous Cell Carcinoma

This phase II trial studies how well radiation therapy works when given with pembrolizumab or cisplatin in treating patients with stages III / IV p16-positive head and neck squamous cell carcinoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving pembrolizumab during and after radiation therapy or cisplatin during radiation therapy works better in treating participants with head and neck squamous cell carcinoma.
Head/Neck
Phase II
Adults
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics, Radiotherapy
Cisplatin, MK-3475, Pembrolizumab (MK-3475)
Gibson, Mike
National
Vanderbilt University
05-21-2020
Treatment
VICCHN1966
NCT03383094

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Informed consent for participation

p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity

High-intermediate risk disease, defined as: * T1-T3 N2 M0 or T3 N1 M0 or any stage III (T4 or N3) p16+ squamous cell carcinoma of the oropharynx (The American Joint Committee on Cancer [AJCC] 8th edition staging system) * T1-2 N1-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the hypopharynx or larynx * T1-2 N2-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the nasopharynx * Inoperable T4 N0-3 M0 (stage IVA-IVB) p16+ squamous cell carcinoma of the oral cavity

Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 28 days prior to registration)

Platelets >= 100,000 cells/mm^3 (obtained within 28 days prior to registration)

Hemoglobin (Hgb) >= 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable (obtained within 28 days prior to registration)

Serum creatinine = 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula (obtained within 28 days prior to registration)

Bilirubin
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
Female subject of childbearing potential should have a negative pregnancy test within 14 days prior to receiving the first dose of study medication

Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject)

Male subjects must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject)



Exclusion Criteria:

Prior malignancy within the past 3 years (except non-melanomatous skin cancer and early stage treated prostate cancer)

Eastern Cooperative Oncology Group (ECOG) performance status >= 2

Prior head and neck radiation, chemotherapy, or immunotherapy

Prior oncologic (radical) surgery to the primary site

Documented evidence of distant metastases

Severe, active co-morbidity defined as follows * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol

Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment

Psychiatric/social situations that would limit compliance with study requirements

Hypersensitivity to pembrolizumab or any of its excipients

Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Known history of, or any evidence of active, non-infectious pneumonitis

Active infection requiring systemic therapy

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies); test only as clinically indicated

Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); test only as clinically indicated

Has received a live vaccine within 30 days of planned start of study therapy * Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

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