Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
MAPKeeper 301
A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)
1 other identifier
interventional
510
2 countries
31
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Jun 2026
Shorter than P25 for phase_3 pancreatic-cancer
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
July 29, 2026
July 1, 2026
2 years
April 20, 2026
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
The OS of participants with atebimetinib in combination with mGnP versus GnP
Up to approximately 2 years
Secondary Outcomes (5)
Progression Free Survival (PFS)
Up to approximately 2 years
Overall Response Rate (ORR)
Up to approximately 2 years
Disease Control Rate (DCR)
Up to approximately 2 years
Incidence of Adverse Events (AEs)
Up to approximately 2 years
Quality of Life (QOL) with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Up to approximately 2 years
Study Arms (2)
Atebimetinib + mGnP
EXPERIMENTALAtebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
GnP
ACTIVE COMPARATORStandard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
City of Hope
Phoenix, Arizona, 85338, United States
City of Hope
Duarte, California, 91010, United States
Medical Oncology Hematology Consultants
Newark, Delaware, 19713, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists - South
Sarasota, Florida, 34239, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, 33701, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401, United States
Piedmont Healthcare
Atlanta, Georgia, 30318, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
City of Hope
Chicago, Illinois, 60099, United States
OSF Medical Center
Peoria, Illinois, 61603, United States
Maryland Oncology
Columbia, Maryland, 21044, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Comprehensive Cancer Centers
Las Vegas, Nevada, 89169, United States
Regional Cancer Care
Belleville, New Jersey, 07109, United States
NYU Langone Health
New York, New York, 10016, United States
Taylor Cancer Research Center
Maumee, Ohio, 43537, United States
Willamette Valley Cancer Institute
Eugene, Oregon, 97401, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology - West Texas
Abilene, Texas, 79606, United States
Texas Oncology - Austin
Austin, Texas, 78705, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78240, United States
Texas Oncology Gulf Coast
Webster, Texas, 77598, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Genesiscare
Waratah, New South Wales, 2298, Australia
Icon Cancer Centre - Chermside
Chermside, Queensland, 4032, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2026
First Posted
May 1, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
July 29, 2026
Record last verified: 2026-07