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

a study on Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

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

Official 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 Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)

Details

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.

Keywords

Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma Metastatic, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Adenocarcinoma, mitogen-activated protein kinase (MAPK), MAPK, MEK, metastatic cancer, gemcitabine, nab-paclitaxel, nab-p, atebimetinib, KRAS, pan-RAS, Pancreatic Neoplasms, Neoplasm Metastasis, GnP, mGnP, Atebimetinib + mGnP

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must be ≥18 years of age
  • Must have confirmed diagnosis according to AJCC staging as follows:
  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego accepting new patients
    San Diego California 92037 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immuneering Corporation
ID
NCT07562152
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 510 study participants
Last Updated
Contact us about this trial