Melanoma Clinical Trials

• Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx

• AJCC 8th Edition Stage III - IV disease (T1-T2/N1-N3, T3-T4/N0-N3)

• Disease (primary \& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT

• ECOG PS 0 - 2

• Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.

• Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.

• Must have normal organ and marrow function as defined below:

‣ Hemoglobin ≥ 9.0 g/dL

⁃ Absolute neutrophil count ≥ 1,500/mcL

⁃ Platelet count ≥ 100,000/mcL

⁃ Total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN)

⁃ AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN)

⁃ ALT (SGPT) ≤ 2.5 X institutional ULN

⁃ Creatinine clearance ≥ 40 mL/min/1.73 m2 for patients with a creatinine level above institutional normal

• Must have the ability to understand and the willingness to sign a written informed consent document.