ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer (KEYNOTE144)
Primary Purpose
Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACP-196
ACP-196 in combination with pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: Arm 1
Experimental: Arm 2
Arm Description
ACP-196 alone
ACP-196 in combination with pembrolizumab
Outcomes
Primary Outcome Measures
Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary Outcome Measures
Full Information
NCT ID
NCT02362048
First Posted
January 28, 2015
Last Updated
September 12, 2019
Sponsor
Acerta Pharma BV
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02362048
Brief Title
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
Acronym
KEYNOTE144
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Arm 1
Arm Type
Experimental
Arm Description
ACP-196 alone
Arm Title
Experimental: Arm 2
Arm Type
Experimental
Arm Description
ACP-196 in combination with pembrolizumab
Intervention Type
Drug
Intervention Name(s)
ACP-196
Intervention Type
Drug
Intervention Name(s)
ACP-196 in combination with pembrolizumab
Primary Outcome Measure Information:
Title
Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
Every 12 weeks for up to 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acerta Clinical Trial
Organizational Affiliation
1-888-292-9613; acertamc@dlss.com
Official's Role
Study Director
Facility Information:
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32114502
Citation
Overman M, Javle M, Davis RE, Vats P, Kumar-Sinha C, Xiao L, Mettu NB, Parra ER, Benson AB, Lopez CD, Munugalavadla V, Patel P, Tao L, Neelapu S, Maitra A. Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer. J Immunother Cancer. 2020 Feb;8(1):e000587. doi: 10.1136/jitc-2020-000587.
Results Reference
derived
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ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
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