This trial is active, not recruiting.

Condition metastatic pancreatic cancer
Treatments acp-196, acp-196 in combination with pembrolizumab
Phase phase 2
Targets BTK, PD-1
Sponsor Acerta Pharma BV
Collaborator Merck Sharp & Dohme Corp.
Start date April 2015
End date May 2017
Trial size 76 participants
Trial identifier NCT02362048, ACE-ST-003


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
ACP-196 alone
ACP-196 in combination with pembrolizumab
acp-196 in combination with pembrolizumab

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (AEs)
time frame: 52 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.
Location data was received from the National Cancer Institute and was last updated in April 2016.