ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer (KEYNOTE144)

Acerta Pharma

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: ACP-196; Drug: ACP-196 in combination with pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02362048

ACE-ST-003

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Experimental: Arm 1

Experimental group

Description:

ACP-196 alone

Treatment:

Drug: ACP-196

Experimental: Arm 2

Experimental group

Description:

ACP-196 in combination with pembrolizumab

Treatment:

Drug: ACP-196 in combination with pembrolizumab