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 at least 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Atebimetinib + mGnP |
Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma |
|
|
Active Comparator GnP |
Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma |
|
Recruiting Locations
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Meredith Pelster, MD
Meredith Pelster, MD
More Details
- Status
- Recruiting
- Sponsor
- Immuneering Corporation
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.