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

17. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

510

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • New South Wales
      • Waratah, New South Wales, Australien, 2298
      • Waratah, New South Wales, Australien, 2298
    • Queensland
      • Chermside, Queensland, Australien, 4032
      • Woolloongabba, Queensland, Australien, 4102
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekruttering
        • Cancer Research South Australia
        • Kontakt:
    • Victoria
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35805
        • Rekruttering
        • Clearview Cancer Institute
        • Kontakt:
          • Ehab El-Bahesh, MD
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85338
    • California
      • Duarte, California, Forenede Stater, 91010
      • San Diego, California, Forenede Stater, 92037
        • Rekruttering
        • University of California San Diego
        • Kontakt:
          • Study Team
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80528
      • Lone Tree, Colorado, Forenede Stater, 80124
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
    • Florida
      • Port Saint Lucie, Florida, Forenede Stater, 34952
        • Rekruttering
        • Hematology Oncology Associates of the Treasure Coast
        • Kontakt:
      • Sarasota, Florida, Forenede Stater, 34239
      • St. Petersburg, Florida, Forenede Stater, 33701
      • West Palm Beach, Florida, Forenede Stater, 33401
    • Georgia
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
      • Chicago, Illinois, Forenede Stater, 60099
      • Peoria, Illinois, Forenede Stater, 61603
    • Kansas
      • Fairway, Kansas, Forenede Stater, 66205
        • Rekruttering
        • University of Kansas Cancer Center
        • Kontakt:
    • Maryland
    • Missouri
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
    • New Jersey
    • New York
      • New York, New York, Forenede Stater, 10016
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
          • Eileen O'Reilly, MD
    • North Carolina
      • Pinehurst, North Carolina, Forenede Stater, 28374
    • Ohio
      • Maumee, Ohio, Forenede Stater, 43537
        • Rekruttering
        • Taylor Cancer Research Center
        • Kontakt:
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
      • Nashville, Tennessee, Forenede Stater, 37203
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Abilene, Texas, Forenede Stater, 79606
      • Austin, Texas, Forenede Stater, 78705
      • San Antonio, Texas, Forenede Stater, 78240
      • Webster, Texas, Forenede Stater, 77598
    • Virginia
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Rekruttering
        • University of Washington Fred Hutchinson Cancer Center
        • Kontakt:
      • Vancouver, Washington, Forenede Stater, 98684
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
  • Georgien
    • TB
      • Tbilisi, TB, Georgien, 0160
        • Rekruttering
        • Caucasus Medical Centre
        • Kontakt:
          • Study Team
      • Tbilisi, TB, Georgien, 0186
        • Rekruttering
        • LTD "Multiprofile Clinic Consilium Medulla"
        • Kontakt:
          • Study Team

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Atebimetinib + mGnP
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Medicin: Atebimetinib
Once daily oral tablets
Medicin: mGnP
Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)
Aktiv komparator: GnP
Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Medicin: GnP
Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Up to approximately 2 years
The OS of participants with atebimetinib in combination with mGnP versus GnP
Up to approximately 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Immuneering Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMM1104-301

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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