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NCT07562152PHASE3Recruiting

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

Immuneering Corporation

Start Date

6/1/2026

Completion Date

2/1/2029

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Atebimetinib

DRUG

GnP

DRUG

mGnP

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Conditions

Pancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Adenocarcinoma MetastaticPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma

Locations

City of Hope

Phoenix, Arizona 85338

United States

City of Hope

Duarte, California 91010

United States

Medical Oncology Hematology Consultants

Newark, Delaware 19713

United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida 34952

United States

Florida Cancer Specialists - South

Sarasota, Florida 34239

United States

Florida Cancer Specialists - North

St. Petersburg, Florida 33701

United States

Florida Cancer Specialists - East

West Palm Beach, Florida 33401

United States

Piedmont Healthcare

Atlanta, Georgia 30318

United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005

United States

City of Hope

Chicago, Illinois 60099

United States

OSF Medical Center

Peoria, Illinois 61603

United States

Maryland Oncology

Columbia, Maryland 21044

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Comprehensive Cancer Centers

Las Vegas, Nevada 89169

United States

Regional Cancer Care

Belleville, New Jersey 07109

United States

NYU Langone Health

New York, New York 10016

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Willamette Valley Cancer Institute

Eugene, Oregon 97401

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

West Cancer Center

Germantown, Tennessee 38138

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Texas Oncology - West Texas

Abilene, Texas 79606

United States

Texas Oncology - Austin

Austin, Texas 78705

United States

Texas Oncology - San Antonio

San Antonio, Texas 78240

United States

Texas Oncology Gulf Coast

Webster, Texas 77598

United States

Blue Ridge Cancer Care

Blacksburg, Virginia 24060

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Northwest Cancer Specialists

Vancouver, Washington 98684

United States

Calvary Mater Newcastle

Waratah, New South Wales 2298

Australia

Genesiscare

Waratah, New South Wales 2298

Australia

Icon Cancer Centre - Chermside

Chermside, Queensland 4032

Australia