Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma (MAPKeeper 301)

September 17, 2026 updated by: Immuneering Corporation

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)

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Chermside, Queensland, Australia, 4032
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cancer Research South Australia
        • Contact:
    • Victoria
  • Georgia
    • TB
      • Tbilisi, TB, Georgia, 0160
        • Recruiting
        • Caucasus Medical Centre
        • Contact:
          • Study Team
      • Tbilisi, TB, Georgia, 0186
        • Recruiting
        • LTD "Multiprofile Clinic Consilium Medulla"
        • Contact:
          • Study Team
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Recruiting
        • Clearview Cancer Institute
        • Contact:
          • Ehab El-Bahesh, MD
    • Arizona
      • Phoenix, Arizona, United States, 85338
    • California
      • Duarte, California, United States, 91010
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Contact:
          • Study Team
    • Colorado
    • Delaware
    • Florida
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • Hematology Oncology Associates of the Treasure Coast
        • Contact:
      • Sarasota, Florida, United States, 34239
      • St. Petersburg, Florida, United States, 33701
      • West Palm Beach, Florida, United States, 33401
    • Georgia
    • Illinois
    • Kansas
      • Fairway, Kansas, United States, 66205
    • Maryland
    • Missouri
    • Nevada
      • Las Vegas, Nevada, United States, 89169
    • New Jersey
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Eileen O'Reilly, MD
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Contact:
    • Oregon
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37203
      • Nashville, Tennessee, United States, 37203
    • Texas
    • Virginia
    • Washington
      • Seattle, Washington, United States, 98109
      • Vancouver, Washington, United States, 98684
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atebimetinib + mGnP
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Drug: Atebimetinib
Once daily oral tablets
Drug: mGnP
Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)
Active Comparator: GnP
Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Drug: GnP
Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to approximately 2 years
The OS of participants with atebimetinib in combination with mGnP versus GnP
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to approximately 2 years
The PFS of participants with atebimetinib in combination with mGnP versus GnP
Up to approximately 2 years
Overall Response Rate (ORR)
Time Frame: Up to approximately 2 years
The ORR of participants with atebimetinib in combination with mGnP versus GnP
Up to approximately 2 years
Disease Control Rate (DCR)
Time Frame: Up to approximately 2 years
The DCR in participants with atebimetinib in combination with mGnP versus GnP
Up to approximately 2 years
Incidence of Adverse Events (AEs)
Time Frame: Up to approximately 2 years
The safety and tolerability of atebimetinib in combination with mGnP versus GnP assessed by percentage of participants with AEs based on Common Terminology Criteria for Adverse Events (CTCAE) v6
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)
Time Frame: Up to approximately 2 years
EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. Change from baseline in EORTC QLQ-C30 global health status will be assessed, with higher scores reflecting better functioning.
Up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Immuneering Corporation

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 Major Dates

Study Start (Actual)

June 5, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMM1104-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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