Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

1. Have histologically or cytologically-confirmed R/M HNSCC that is consideredincurable by local therapies. Subjects should not have had prior systemic therapy administered in the recurrent ormetastatic setting. Systemic therapy which was completed more than 6 months prior tosigning consent if given as part of multimodal treatment for locally advanceddisease is allowed. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, andlarynx. Subjects may not have a primary tumor site of nasopharynx (any histology).

2. Be willing and able to provide written informed consent for the trial.

3. Have results from testing of PD-L1 status.

4. Be ≥ 20 years of age on day of signing informed consent.

5. Have measurable disease based on RECIST 1.1. Lesions situated in a previouslyirradiated area are considered measurable if progression has been demonstrated insuch lesions.

6. Have a performance status of 0 or 1 on the ECO G Performance Scale.

7. Have adequate organ function.

8. Have results from testing of HPV status for oropharyngeal cancer.

9. Female subjects of childbearing potential should have a negative blood pregnancytest within 72 hours prior to receiving the first dose of study medication.

10. Female subjects of childbearing potential should be willing to use 2 methods ofbirth control or be surgically sterile or abstain from heterosexual activity for thecourse of the study through 180 days after the last dose of study medication.

11. Male subjects should agree to use an adequate method of contraception starting withthe first dose of study therapy through 180 days after the last dose of studytherapy.

Exclusion Criteria:

1. Has disease that is suitable for local therapy administered with curative intent.

2. Has a life expectancy of less than 3 months and/ or has rapidly progressing diseasein the opinion of the treating investigator.

3. Has received prior systemic anti-cancer therapy including radiation therapy, othernon-systemic therapy or investigational agents within 4 weeks prior to the firstdose of trial treatment.

4. Is currently participating and receiving study therapy or has participated in astudy of an investigational agent and received study therapy, or used aninvestigational device, any of which occurred within 4 weeks of the first dose oftreatment.

5. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (usingprednisolone ≥ 10mg per day) or any other form of immunosuppressive therapy within 7days prior to the first dos e of trial treatment.

6. Has a diagnosed and/or treated additional malignancy within 2 years prior torandomization with the exception of curatively treated basal cell carcinoma of theskin, squamous cell carcinoma of the skin, curatively resected esophageal cancer,curatively resected in situ cervical cancer, and curatively resected in situ cancer.

7. Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.

8. Active autoimmune disease that has required systemic treatment in past 2 years (i.e.with use of disease modifying agents, corticosteroids or immunosuppressive drugs).

9. Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis. Pneumonitis include active radiation pneumonitis.

10. Has an active infection requiring systemic therapy.

11. Has received prior therapy with an anti-PD-1, a nti-PD-L1, or anti-CTLA-4 agent.

12. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Hasknown active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA isdetected).