Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Purpose
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
Conditions
- Pancreatic Cancer
- Pancreatic Cancer Metastatic
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma
- Pancreatic Adenocarcinoma Metastatic
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Pancreatic Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Must be ≥18 years of age - Must have confirmed diagnosis according to AJCC staging as follows: - Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Participants must be treatment naive as follows: - First-line PDAC participants will have received no previous systemic anti-cancer therapy - Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria - Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values
Exclusion Criteria
- Inability to swallow oral medications - Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma - Participants with only locally advanced disease - Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Atebimetinib + mGnP |
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma |
|
|
Active Comparator GnP |
Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma |
|
Recruiting Locations
Poudre Valley Health Care, Inc
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
Rocky Mountain Cancer Centers
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Medical Oncology Hematology Consultants
Newark, Delaware 19713
Newark, Delaware 19713
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
Florida Cancer Specialists - South
Sarasota, Florida 34239
Sarasota, Florida 34239
Florida Cancer Specialists - North
St. Petersburg, Florida 33701
St. Petersburg, Florida 33701
Florida Cancer Specialists - East
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Piedmont Cancer Institute
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Illinois Cancer Specialists
Arlington Heights, Illinois 60005
Arlington Heights, Illinois 60005
OSF Medical Center
Peoria, Illinois 61603
Peoria, Illinois 61603
Missouri Cancer Associates
Columbia, Missouri 65201
Columbia, Missouri 65201
Comprehensive Cancer Centers
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Regional Cancer Care
Belleville, New Jersey 07109
Belleville, New Jersey 07109
FirstHealth of the Carolinas
Pinehurst, North Carolina 28374
Pinehurst, North Carolina 28374
Willamette Valley Cancer Institute
Eugene, Oregon 97401
Eugene, Oregon 97401
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Avera Cancer Institute Research
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Texas Oncology - West Texas
Abilene, Texas 79606
Abilene, Texas 79606
Texas Oncology - San Antonio
San Antonio, Texas 78240
San Antonio, Texas 78240
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
University of Washington Fred Hutchinson Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
Northwest Cancer Specialists
Vancouver, Washington 98684
Vancouver, Washington 98684
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
More Details
- Status
- Recruiting
- Sponsor
- Immuneering Corporation
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with atebimetinib plus a modified schedule of gemcitabine and nab-paclitaxel will improve overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma. Patients will be randomized to one of two arms: Arm A with atebimetinib + gemcitabine and nab-paclitaxel (modified dosing schedule) or Arm B with gemcitabine and nab-paclitaxel.