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Not yet recruitingLast updated: 6 July 2026

MAPKeeper 301: Is adding targeted therapy to standard chemotherapy safe and effective for people with metastatic pancreatic cancer?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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

MAPKeeper 301

Clinical summary

Summary

The trial is testing whether adding a targeted drug called atebimetinib to standard chemotherapy improves outcomes.

Participants are randomly assigned (by chance) to one of two groups:

  • New treatment group: atebimetinib + chemotherapy (gemcitabine and nab-paclitaxel)
  • Standard treatment group: chemotherapy alone (gemcitabine and nab-paclitaxel)

The goal is to see if the new combination helps people live longer compared to standard treatment.

Who can take part?
You may be eligible if you:

  • are aged 18 years or older
  • are diagnosed with metastatic pancreatic adenocarcinoma
  • have not yet had treatment for their advanced cancer. Treatment for an earlier stage of cance rmay be permitted.

Key exclusions include:

  • Cancer that has not spread (only locally advanced or localised)
  • Certain rare pancreatic cancer types
  • Some serious medical conditions (e.g. uncontrolled brain metastases)

Conditions

This trial is treating people with metastatic pancreatic cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Immuneering Corporation

Scientific 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)

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