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

RecruitingPhase 3

Sponsor: Immuneering Corporation

Conditions: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma

Interventions: Atebimetinib, GnP, mGnP

Countries: United States, Australia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (30)

Phoenix, Arizona, United States
Duarte, California, United States
Newark, Delaware, United States
Port Saint Lucie, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Columbia, Maryland, United States
Columbia, Missouri, United States
Las Vegas, Nevada, United States
Belleville, New Jersey, United States
New York, New York, United States
Maumee, Ohio, United States
Eugene, Oregon, United States
Philadelphia, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Blacksburg, Virginia, United States
Fairfax, Virginia, United States
Vancouver, Washington, United States
Waratah, New South Wales, Australia
Chermside, Queensland, Australia