Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

17. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

510

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Rekruttering
        • Icon Cancer Centre - Chermside
        • Ta kontakt med:
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Rekruttering
        • Cancer Research South Australia
        • Ta kontakt med:
    • Victoria
      • Frankston East, Victoria, Australia, 3199
  • Forente stater
    • Alabama
      • Huntsville, Alabama, Forente stater, 35805
        • Rekruttering
        • Clearview Cancer Institute
        • Ta kontakt med:
          • Ehab El-Bahesh, MD
    • Arizona
      • Phoenix, Arizona, Forente stater, 85338
    • California
      • Duarte, California, Forente stater, 91010
        • Rekruttering
        • City of Hope
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92037
        • Rekruttering
        • University of California San Diego
        • Ta kontakt med:
          • Study Team
    • Colorado
      • Fort Collins, Colorado, Forente stater, 80528
      • Lone Tree, Colorado, Forente stater, 80124
    • Delaware
      • Newark, Delaware, Forente stater, 19713
    • Florida
      • Port Saint Lucie, Florida, Forente stater, 34952
        • Rekruttering
        • Hematology Oncology Associates of the Treasure Coast
        • Ta kontakt med:
      • Sarasota, Florida, Forente stater, 34239
      • St. Petersburg, Florida, Forente stater, 33701
      • West Palm Beach, Florida, Forente stater, 33401
    • Georgia
      • Atlanta, Georgia, Forente stater, 30318
      • Atlanta, Georgia, Forente stater, 30318
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
      • Chicago, Illinois, Forente stater, 60099
        • Rekruttering
        • City of Hope
        • Ta kontakt med:
      • Peoria, Illinois, Forente stater, 61603
    • Kansas
      • Fairway, Kansas, Forente stater, 66205
        • Rekruttering
        • University of Kansas Cancer Center
        • Ta kontakt med:
    • Maryland
    • Missouri
      • Columbia, Missouri, Forente stater, 65201
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89169
    • New Jersey
    • New York
      • New York, New York, Forente stater, 10016
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Ta kontakt med:
          • Eileen O'Reilly, MD
    • North Carolina
      • Pinehurst, North Carolina, Forente stater, 28374
    • Ohio
      • Maumee, Ohio, Forente stater, 43537
        • Rekruttering
        • Taylor Cancer Research Center
        • Ta kontakt med:
    • Oregon
      • Eugene, Oregon, Forente stater, 97401
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57105
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
      • Nashville, Tennessee, Forente stater, 37203
      • Nashville, Tennessee, Forente stater, 37203
    • Texas
      • Abilene, Texas, Forente stater, 79606
      • Austin, Texas, Forente stater, 78705
      • San Antonio, Texas, Forente stater, 78240
      • Webster, Texas, Forente stater, 77598
    • Virginia
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • University of Washington Fred Hutchinson Cancer Center
        • Ta kontakt med:
      • Vancouver, Washington, Forente stater, 98684
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
  • Georgia
    • TB
      • Tbilisi, TB, Georgia, 0160
        • Rekruttering
        • Caucasus Medical Centre
        • Ta kontakt med:
          • Study Team
      • Tbilisi, TB, Georgia, 0186
        • Rekruttering
        • LTD "Multiprofile Clinic Consilium Medulla"
        • Ta kontakt med:
          • Study Team

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Atebimetinib + mGnP
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
Legemiddel: Atebimetinib
Once daily oral tablets
Legemiddel: 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
Legemiddel: GnP
Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Immuneering Corporation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

20. april 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IMM1104-301

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere