Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Recruiting · NCT07562152 · Interventional (participants receive a specific treatment) · Lead sponsor: Immuneering Corporation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
41 locations listed across 23 US states.
- Clearview Cancer Institute - Huntsville, Alabama, United States
- City of Hope - Phoenix, Arizona, United States
- City of Hope - Duarte, California, United States
- Poudre Valley Health Care, Inc - Fort Collins, Colorado, United States
- Rocky Mountain Cancer Centers - Lone Tree, Colorado, United States
- Medical Oncology Hematology Consultants - Newark, Delaware, United States
- Hematology Oncology Associates of the Treasure Coast - Port Saint Lucie, Florida, United States
- Florida Cancer Specialists - South - Sarasota, Florida, United States
- Florida Cancer Specialists - North - St. Petersburg, Florida, United States
- Florida Cancer Specialists - East - West Palm Beach, Florida, United States
- Piedmont Cancer Institute - Atlanta, Georgia, United States
- Piedmont Healthcare - Atlanta, Georgia, United States
- Illinois Cancer Specialists - Arlington Heights, Illinois, United States
- City of Hope - Chicago, Illinois, United States
- OSF Medical Center - Peoria, Illinois, United States
- Maryland Oncology - Columbia, Maryland, United States
- Missouri Cancer Associates - Columbia, Missouri, United States
- Comprehensive Cancer Centers - Las Vegas, Nevada, United States
- Regional Cancer Care - Belleville, New Jersey, United States
- NYU Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- FirstHealth of the Carolinas - Pinehurst, North Carolina, United States
- Taylor Cancer Research Center - Maumee, Ohio, United States
- Willamette Valley Cancer Institute - Eugene, Oregon, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- Avera Cancer Institute Research - Sioux Falls, South Dakota, United States
- West Cancer Center - Germantown, Tennessee, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- Texas Oncology - West Texas - Abilene, Texas, United States
- Texas Oncology - Austin - Austin, Texas, United States
- Texas Oncology - San Antonio - San Antonio, Texas, United States
- Texas Oncology Gulf Coast - Webster, Texas, United States
- Blue Ridge Cancer Care - Blacksburg, Virginia, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- University of Washington Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Northwest Cancer Specialists - Vancouver, Washington, United States
- University of Wisconsin Carbone Cancer Center - Madison, Wisconsin, United States
- Calvary Mater Newcastle - Waratah, New South Wales, Australia
- Genesiscare - Waratah, New South Wales, Australia
- Icon Cancer Centre - Chermside - Chermside, Queensland, Australia
- Princess Alexandra Hospital - Woolloongabba, Queensland, Australia