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Recruiting

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

NCT07562152 · Immuneering Corporation
In plain English

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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)
About this study
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.
Eligibility criteria
Inclusion Criteria: * Must be ≥18 years of age * Must have confirmed diagnosis according to AJCC staging as follows: * Metastatic pancreatic adenocarcinoma at least 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
Enrollment target: 510 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06
Estimated completion: 2029-02
Last updated: 2026-06-04
Interventions
Drug: AtebimetinibDrug: GnPDrug: mGnP
Primary outcomes
  • Overall Survival (Up to approximately 2 years)
Sponsor
Immuneering Corporation · industry
Contacts & investigators
ContactImmuneering Study Team · contact · clinicaltrials@immuneering.com · 860-321-1302
All locations (10)
City of HopeRecruiting
Phoenix, Arizona, United States
City of HopeRecruiting
Duarte, California, United States
Piedmont HealthcareRecruiting
Atlanta, Georgia, United States
City of HopeRecruiting
Chicago, Illinois, United States
Missouri Cancer AssociatesRecruiting
Columbia, Missouri, United States
Comprehensive Cancer CentersRecruiting
Las Vegas, Nevada, United States
Regional Cancer CareRecruiting
Belleville, New Jersey, United States
NYU Langone HealthRecruiting
New York, New York, United States
Taylor Cancer Research CenterRecruiting
Maumee, Ohio, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma · TrialPath