Protocol No.UW26057
IMM1104-301
Principal InvestigatorUboha, Nataliya
PhaseIII
Age GroupAdult
ClinicalTrials.GovNCT07562152 (Click to jump to clinicaltrials.gov)
Management Group(s) Gastrointestinal

Title
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 Adenocarcinoma Cancer (MAPKeeper 301)

Description
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)

Objective
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Treatment 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.

Key Eligibility 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

Applicable Disease Sites
Pancreas

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital