Atebimetinib plus gemcitabine and nab‑paclitaxel as first‑line treatment for metastatic pancreatic cancer
A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)
This trial will test whether adding the MAPK pathway drug atebimetinib to gemcitabine and nab‑paclitaxel helps people with newly diagnosed metastatic pancreatic ductal adenocarcinoma live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Immuneering Corporation Industry-sponsored |
| Drugs / interventions | atebimetinib |
| Locations | 6 sites (Phoenix, Arizona and 5 other locations) |
| Trial ID | NCT07562152 on ClinicalTrials.gov |
What this trial studies
This is a global, randomized, open‑label Phase 3 study that assigns patients to either atebimetinib combined with a modified schedule of gemcitabine and nab‑paclitaxel or to standard gemcitabine and nab‑paclitaxel as first‑line therapy. Eligible participants are adults with treatment‑naive metastatic pancreatic ductal adenocarcinoma, ECOG performance status 0–1, and measurable disease per RECIST v1.1. The primary outcome is overall survival, with safety and other efficacy endpoints monitored throughout treatment. The study is being run at multiple City of Hope sites in the United States.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed, treatment‑naive metastatic pancreatic ductal adenocarcinoma, ECOG 0–1, measurable disease, and adequate organ function are the intended candidates.
Not a fit: Patients with non‑adenocarcinoma pancreatic tumors (for example neuroendocrine or acinar histology), only locally advanced disease, inability to swallow oral medication, or untreated symptomatic CNS metastases are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could extend overall survival compared with the current standard gemcitabine/nab‑paclitaxel regimen.
How similar studies have performed: Previous efforts to target the MAPK/MEK pathway in pancreatic cancer have shown limited success, so combining a MEK pathway agent with frontline chemotherapy is a relatively novel approach that is not yet proven in Phase 3.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona and 5 other locations
- City of Hope — Phoenix, Arizona, United States (Recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- City of Hope — Chicago, Illinois, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Taylor Cancer Research Center — Maumee, Ohio, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Immuneering Study Team
- Email: clinicaltrials@immuneering.com
- Phone: 860-321-1302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.