Atebimetinib plus gemcitabine and nab‑paclitaxel as first‑line treatment for metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• City of Hope
  Phoenix, Arizona, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• University of California San Diego
  San Diego, California, United States Recruiting
• Poudre Valley Health Care, Inc
  Fort Collins, Colorado, United States Recruiting
• Rocky Mountain Cancer Centers
  Lone Tree, Colorado, United States Recruiting

+26 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Immuneering Study Team
• Email: clinicaltrials@immuneering.com
• Phone: 860-321-1302

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.