Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

- Men and women ≥ 18 years of age

- Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC
of the oral cavity, oropharynx, hypopharynx, and larynx that that has either
progressed during or after platinum-based chemotherapy administered for metastatic
disease or has recurred during or within 6 months after the completion of
platinum-based neoadjuvant or adjuvant therapy

- Presence of radiographically measurable disease as defined by RECIST 1.1

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Prior malignancy (other than HNSCC), except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
subject has been disease free for ≥ 2 years or which will not limit survival to < 2
years

- Known central nervous system metastases and/or carcinomatous meningitis

- A life-threatening illness, medical condition (including psychiatric conditions) or
organ system dysfunction which, in the investigator's opinion, could compromise the
subject's safety

- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
congestive heart failure, or myocardial infarction within 6 months of starting study
drug