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Pancreatic CancerPhase 3MAPKeeper 301NCT07562152

Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

A Phase 3 study testing Atebimetinib, GnP and mGnP in people with Pancreatic Cancer and Pancreatic Cancer Metastatic, run by Immuneering Corporation at 76 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atebimetinib, GnP and mGnP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
76 sitesin 9 countries
Study dates
5 Jun 2026to Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

76 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Immuneering Study Team contact

860-321-1302

clinicaltrials@immuneering.com

76 sites in 9 countries

United States47 sites, 47 recruiting

  • Texas Oncology - West Texas

    Abilene, Texas, 79606

    Michole Logan, michole.logan@usoncology.com

    Recruiting

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

    Study Team, aearles@illinoiscancercare.com

    Recruiting

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318

    Katie Adams, KAdams@piedmontcancerinstitute.com

    Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30318

    Study Team, ORRTeam@piedmont.org

    Recruiting

  • Texas Oncology - Austin

    Austin, Texas, 78705

    Marian Heaven, marian.heaven@usoncology.com

    Recruiting

  • Regional Cancer Care

    Belleville, New Jersey, 07109

    Denise Johnstone, denise.johnstone@regionalcancercare.org

    Recruiting

  • Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

    Natasha Holt, natasha.holt@usoncology.com

    Recruiting

  • City of Hope

    Chicago, Illinois, 60099

    Jalene Tangen, jtangen@coh.org

    Recruiting

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219

    Study Team, cancer@UChealth.com

    Recruiting

  • Maryland Oncology

    Columbia, Maryland, 21044

    Corilynn Hughes, corilynn.hughes@usoncology.com

    Recruiting

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

    Crystal Johnson, crystal.johnson@usoncology.com

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Jalene Tangen, jtangen@coh.org

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Study Team, clinical.trial@asterahealthcare.org

    Recruiting

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

    Jeanne Schaffer, jeanne.schaffer@usoncology.com

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Study Team, VCSResearchReferrals@usoncology.com

    Recruiting

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

    Study Team, CTNurseNav@kumc.edu

    Recruiting

  • Poudre Valley Health Care, Inc

    Fort Collins, Colorado, 80528

    Study Team, OncResearch.North@uchealth.org

    Recruiting

  • West Cancer Center

    Germantown, Tennessee, 38138

    Robin Patterson, rpatterson@westclinic.com

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29605

    Kim Williams, kim.williams3@prismahealth.org

    Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

    Lisa Chapuran, lchapuran@ccihsv.com

    Recruiting

  • Comprehensive Cancer Centers

    Las Vegas, Nevada, 89169

    Lindsay Kondo, lindsay.kondo@usoncology.com

    Recruiting

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

    Jennifer Hege, jennifer.hege@usoncology.com

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Study Team, cancerconnect@uwhealth.org

    Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Stephanie Ambrose, sambrose@tcrcpt.org

    Recruiting

  • Miami Cancer Institute

    Miami, Florida, 33176

    Study Team

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Study Team, SCRI.ResearchReferrals@scresearch.net

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Catt Pecknold, cpecknold@tnonc.com

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Study Team, ct.gov@nyulangone.org

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Eileen O'Reilly, MD

    Recruiting

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19713

    Elizabeth MacWade, elizabeth.macwade@usoncology.com

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Mahdi Hassan, mhassan@unmc.edu

    Recruiting

  • OSF Medical Center

    Peoria, Illinois, 61603

    Peyton Swearingen, peyton.o.swearingen@osfhealthcare.org

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Study Team, OncTrialNow@Jefferson.edu

    Recruiting

  • City of Hope

    Phoenix, Arizona, 85338

    Study Team, phxresearch@coh.org

    Recruiting

  • FirstHealth of the Carolinas

    Pinehurst, North Carolina, 28374

    Heather Martin, hmartin@firsthealth.org

    Recruiting

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

    Christine Gerdes, cgerdes@hemoncfl.com

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97201

    Study Team, trials@ohsu.edu

    Recruiting

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78240

    Shannon Syring, shannon.syring@usoncology.com

    Recruiting

  • University of California San Diego

    San Diego, California, 92037

    Study Team, CancerCTO@health.ucsd.edu

    Recruiting

  • Florida Cancer Specialists - South

    Sarasota, Florida, 34239

    Study Team, clinicaltrials@flcancer.com

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Study Team, crp@benaroyaresearch.org

    Recruiting

  • University of Washington Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Study Team, GIResearch@fredhutch.org

    Recruiting

  • Avera Cancer Institute Research

    Sioux Falls, South Dakota, 57105

    Study Coordinator, MedOncResearch@avera.org

    Recruiting

  • Florida Cancer Specialists - North

    St. Petersburg, Florida, 33701

    Study Team, clinicaltrials@flcancer.com

    Recruiting

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

    Susan Papenfuse, susan.papenfuse@usoncology.com

    Recruiting

  • Texas Oncology Gulf Coast

    Webster, Texas, 77598

    Tara Gray, tara.gray@usoncology.com

    Recruiting

  • Florida Cancer Specialists - East

    West Palm Beach, Florida, 33401

    Study Team, clinicaltrials@flcancer.com

    Recruiting

Other trials in United States

Australia9 sites, 9 recruiting

  • Cancer Research South Australia

    Adelaide, South Australia, 5000

    Vineet Kwatra, MD, vkwatra@crsa.au

    Recruiting

  • Icon Cancer Centre - Chermside

    Chermside, Queensland, 4032

    Jesse Peet, +61 07 3737 4539, researchchermside@icon.team

    Recruiting

  • Bayside Health

    Frankston East, Victoria, 3199

    Sally Heath, sallyheath@phcn.vic.gov.au

    Recruiting

  • Nepean Cancer Care Centre

    Kingswood, New South Wales, 2747

    Study Team

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Study Team

    Recruiting

  • One Clinical Research

    Nedlands, Western Australia, 6009

    Study Team

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Kerrie Cornall, +61 04 0144 3282, kerrie.cornall@health.nsw.gov.au

    Recruiting

  • Genesiscare

    Waratah, New South Wales, 2298

    Kim Bloomfield, +61 02 4632 5500, kim.bloomfield@genesicare.com.au

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Ann-Marie Forsyth, ann-marie.forsyth@healthqld.gov.au

    Recruiting

Other trials in Australia

United Kingdom5 sites, 5 recruiting

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, COV, CV2 2DX

    Study Team, research.enquiries@uhcw.nhs.uk

    Recruiting

  • University College London Hospitals

    London, LND, NW1 2BU

    Study Team

    Recruiting

  • Imperial College Healthcare NHS

    London, LND, W12 0HS

    Michela Cicchetti, michela.cicchetti@nhs.net

    Recruiting

  • Scri Uk, Ltd

    London, LND, W1G 6AF

    Study Team

    Recruiting

  • The Christie NHS Foundation

    Manchester, MAN, M20 4BX

    Jessica Jones, jessica.jones136@nhs.net

    Recruiting

Other trials in United Kingdom

Hungary4 sites, 4 recruiting

  • BKVMK

    Budapest, BD, 6000

    Study Team

    Recruiting

  • Pankreasz Betegsegek Intezete, Semmelweis University

    Budapest, BU, 1083

    Study Team

    Recruiting

  • Orszagos Onkologiai Intezet

    Budapest, BU, 1122

    Study Team

    Recruiting

  • University of Debrecen

    Debrecen, H-4032

    Study Team

    Recruiting

Other trials in Hungary

Georgia3 sites, 3 recruiting

  • Institute of Clinical Oncology

    Tbilisi, TB, 0159

    Study Team

    Recruiting

  • Caucasus Medical Centre

    Tbilisi, TB, 0160

    Nino Khunashvili, ninokhunashvili.2@gmail.com

    Recruiting

  • LTD "Multiprofile Clinic Consilium Medulla"

    Tbilisi, TB, 0186

    Tamta Makharadze, MD, tamta.makharadze@gmail.com

    Recruiting

Other trials in Georgia

Germany2 sites, 2 recruiting

  • SLK-Kliniken Heilbronn GMBH

    Heilbronn, Baden-Wurttemberg, 74078

    Josef Huber, MD, josef.huber@slk-kliniken.ed

    Recruiting

  • Elblandklinikum Riesa

    Riesa, Saxony, 01589

    Study Team

    Recruiting

Other trials in Germany

Poland2 sites, 2 recruiting

  • Pratia Poznan

    Poznan, 60-192

    Study Team

    Recruiting

  • Pratia S.A.

    Wroclaw, 50-019

    Study Team

    Recruiting

Other trials in Poland

Romania2 sites, 2 recruiting

  • FutureMeds SRL - Galati

    Galati, GL, 800183

    Mihai Mutică, mihai.mutica@futuremeds.com

    Recruiting

  • SC Sigmedical S.R.L

    Suceava, 720214

    Study Team

    Recruiting

Other trials in Romania

Spain2 sites, 2 recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008

    Study Team, ensayoscun@unav.es

    Recruiting

  • Instituto de Investigacion Sanitaria de Aragon (IIS-A)

    Zaragoza, 50009

    Study Team

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Atebimetinib, GnP, mGnP
Keywords
mitogen-activated protein kinase (MAPK), MAPK, MEK, metastatic cancer, gemcitabine, nab-paclitaxel, nab-p, atebimetinib, KRAS, pan-RAS
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtebimetinibDrug

    Once daily oral tablets

  • GnPDrug

    Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

  • mGnPDrug

    Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)

Study groups in NCT07562152
Study groupRoleWhat they receive
Atebimetinib + mGnPExperimentalAtebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Receives: Drug: Atebimetinib; Drug: mGnP
GnPActive comparatorStandard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Receives: Drug: GnP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    The OS of participants with atebimetinib in combination with mGnP versus GnP

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    The PFS of participants with atebimetinib in combination with mGnP versus GnP

    Measured: Up to approximately 2 years

  2. Overall Response Rate (ORR)

    The ORR of participants with atebimetinib in combination with mGnP versus GnP

    Measured: Up to approximately 2 years

  3. Disease Control Rate (DCR)

    The DCR in participants with atebimetinib in combination with mGnP versus GnP

    Measured: Up to approximately 2 years

  4. Incidence of Adverse Events (AEs)

    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

    Measured: Up to approximately 2 years

  5. Quality of Life (QOL) with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    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.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start5 Jun 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
570 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07562152
Sponsor's protocol ID
IMM1104-301
Acronym
MAPKeeper 301
Status last verified
Nov 2026
First submitted
20 Apr 2026
Last updated
6 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atebimetinib, GnP and mGnP in people with Pancreatic Cancer and Pancreatic Cancer Metastatic, run by Immuneering Corporation at 76 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Australia, United Kingdom, Hungary, Georgia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Immuneering Study Team (860-321-1302, clinicaltrials@immuneering.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07562152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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