Phase 3 Study Comparing Atebimetinib Plus Modified Gemcitabine and Nab-Paclitaxel Versus Standard Gemcitabine and Nab-Paclitaxel for First-Line Treatment of Metastatic Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating the combination of atebimetinib with a modified schedule of gemcitabine and nab-paclitaxel compared to the standard gemcitabine and nab-paclitaxel regimen in patients with metastatic pancreatic adenocarcinoma. This Phase 3, global, randomized, open-label study aims to determine if the new combination improves overall survival when used as a first-line treatment. The study focuses on patients who have not received prior systemic anti-cancer therapy and have measurable disease. Participants will be randomly assigned to one of two groups one group will receive atebimetinib daily by mouth along with biweekly intravenous infusions of gemcitabine and nab-paclitaxel modified dosing, while the other group will receive the standard regimen of weekly intravenous infusions of gemcitabine and nab-paclitaxel for three weeks followed by one week without treatment. Treatment continues as per the study protocol to compare these approaches. Throughout the study, participants will undergo assessments including measurements of overall survival, progression-free survival, response rates, disease control, adverse events, and quality of life using a standardized questionnaire. These evaluations will be conducted for up to approximately two years. Safety and treatment effects will be closely monitored during this time, with the entire study expected to complete by early 2029.

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