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

Purpose

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Conditions

  • Pancreatic Cancer
  • Pancreatic Cancer Metastatic
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Pancreatic Adenocarcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Atebimetinib + mGnP 		Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
  • Drug: Atebimetinib
    Once daily oral tablets
  • Drug: mGnP
    Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)
Active Comparator
GnP 		Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
  • Drug: Atebimetinib
    Once daily oral tablets
  • Drug: GnP
    Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion
  • Drug: mGnP
    Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)

Recruiting Locations

City of Hope
Phoenix, Arizona 85338
Contact:
Khaled Abouelezz, MD
phxresearch@coh.org

City of Hope
Duarte, California 91010
Contact:
Jalene Tangen
jtangen@coh.org

Piedmont Healthcare
Atlanta, Georgia 30318
Contact:
Eyal Meiri, MD

City of Hope
Chicago, Illinois 60099
Contact:
Jalene Tangen
jtangen@coh.org

OSF Medical Center
Peoria, Illinois 61603
Contact:
Peyton Swearingen
peyton.o.swearingen@osfhealthcare.org

Missouri Cancer Associates
Columbia, Missouri 65201
Contact:
Crystal Johnson
crystal.johnson@usoncology.com

Comprehensive Cancer Centers
Las Vegas, Nevada 89169
Contact:
Lindsay Kondo
lindsay.kondo@usoncology.com

Regional Cancer Care
Belleville, New Jersey 07109
Contact:
Denise Johnstone
denise.johnstone@regionalcancercare.org

NYU Langone Health
New York, New York 10016
Contact:
Study Team
ct.gov@nyulangone.org

Taylor Cancer Research Center
Maumee, Ohio 43537
Contact:
Stephanie Ambrose
sambrose@tcrcpt.org

Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Contact:
Zuly Delgado
Zuleika.delgado@jefferson.edu

Sarah Cannon Research Institute
Nashville, Tennessee 37203
Contact:
Meredith Pelster, MD
SCRI.ResearchReferrals@scresearch.net

Texas Oncology - San Antonio
San Antonio, Texas 78240
Contact:
Angel Mier-Hicks, MD

Texas Oncology Gulf Coast
Webster, Texas 77598
Contact:
Tara Gray
tara.gray@usoncology.com

Blue Ridge Cancer Care
Blacksburg, Virginia 24060
Contact:
Natasha Holt
natasha.holt@usoncology.com

More Details

Status
Recruiting
Sponsor
Immuneering Corporation

Study Contact

Immuneering Study Team
860-321-1302
clinicaltrials@immuneering.com

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.