ACP-196 Alone And In Combination With Pembrolizumab In Subjects With Advanced Or Metastatic Pancreatic Cancer

Study Overview

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

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

N/A

Metastatic Pancreatic Cancer

DRUG: ACP-196
DRUG: ACP-196 in combination with pembrolizumab

ACE-ST-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-28	Results First Submitted 2019-07-19	Last Update Submitted that met QC Criteria 2019-09-12
First Submitted that Met QC Criteria 2015-02-07	Results First Submitted that Met QC Criteria 2019-09-12	Last Update Posted (ACTUAL) 2019-10-01
First Posted (ACTUAL) 2015-02-12	Results First Posted 2019-10-01	Last Verified 2019-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental: Arm 1 ACP-196 alone	DRUG: ACP-196
EXPERIMENTAL: Experimental: Arm 2 ACP-196 in combination with pembrolizumab	DRUG: ACP-196 in combination with pembrolizumab

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental: Arm 1

ACP-196 alone

DRUG: ACP-196

EXPERIMENTAL: Experimental: Arm 2

ACP-196 in combination with pembrolizumab

DRUG: ACP-196 in combination with pembrolizumab

Primary Outcome Measures	Measure Description	Time Frame
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	Every 12 weeks for up to 2 years.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Merck Sharp & Dohme LLC

Investigators

STUDY_DIRECTOR: Acerta Clinical Trial, 1-888-292-9613; acertamc@dlss.com

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Clinical Trial Record