ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria:

• Men and women ≥ 18 years of age
• ECOG performance status of 0 or 1
• Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
• Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy

Exclusion Criteria:

• Prior malignancy (other than pancreatic cancer), 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 (CNS) metastases and/or carcinomatous meningitis
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction
• Breastfeeding or pregnant

AE collected time frame was From the date of the first dose of study drug, through the treatment phase, and within 30 days following the last dose of Acalabrutinib or within 90 days following the last dose of Pembrolizumab.

Subjects with multiple events for a given preferred term (PT) were counted only once for each PT. If the same event term was reported more than once for a subject, only the event with the highest grade was included.