510 Participants NeededMy employer runs this trial

Atebimetinib + GnP for Pancreatic Cancer

(MAPKeeper 301 Trial)

Recruiting at 47 trial locations
IS
Overseen ByImmuneering Study Team
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Immuneering Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment combination for pancreatic cancer. It tests atebimetinib with a modified version of the standard chemotherapy drugs gemcitabine and nab-paclitaxel (known as GnP) to determine if it is more effective and safe than the usual treatment. Participants should have pancreatic cancer that has metastasized and have not received prior treatment for it. The goal is to discover better options for individuals facing this challenging condition. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in pancreatic cancer care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that using atebimetinib with a modified version of gemcitabine and nab-paclitaxel (mGnP) for treating pancreatic cancer is generally safe and well-tolerated. In these studies, this combination led to a promising 94% survival rate at six months. At nine months, the survival rate was 86%, with 53% of patients experiencing no cancer progression. These results suggest that the treatment is effective and has a good safety profile. Reported side effects have not been significant, indicating that patients tolerate the treatment well.12345

Why do researchers think this study treatment might be promising for pancreatic cancer?

Atebimetinib + mGnP is unique because it combines atebimetinib with a modified version of the standard chemotherapy regimen, gemcitabine plus nab-paclitaxel (GnP), for pancreatic cancer. Unlike the standard treatment, which solely relies on these chemotherapy agents, atebimetinib introduces a new mechanism of action by potentially targeting specific pathways involved in cancer cell growth and survival. Researchers are excited about this combination because it could enhance the effectiveness of traditional chemotherapy, offering improved outcomes for patients with pancreatic cancer.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that a new treatment combining atebimetinib with a modified version of gemcitabine and nab-paclitaxel (mGnP) holds promise for pancreatic cancer. In this trial, participants will receive either the experimental combination of atebimetinib with mGnP or the standard treatment of gemcitabine and nab-paclitaxel (GnP). Studies found that the combination of atebimetinib with mGnP achieved an impressive 86% survival rate at nine months, surpassing the usual treatment with just gemcitabine and nab-paclitaxel. Additionally, 53% of patients lived without their cancer worsening for nine months. These findings suggest that atebimetinib with mGnP might be more effective at slowing pancreatic cancer than standard treatments.34678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed metastatic pancreatic adenocarcinoma who haven't had prior treatment for this cancer. Participants need to be in good physical condition, have measurable disease, and proper organ function. People with other types of pancreatic tumors or brain metastases can't join.

Inclusion Criteria

I am 18 years old or older.
I was diagnosed with metastatic pancreatic cancer at least 12 weeks ago.
I am fully active or can do light work despite my illness.
See 3 more

Exclusion Criteria

I cannot swallow pills or oral medications.
I have been diagnosed with a specific type of pancreatic cancer.
My cancer is only locally advanced and has not spread to distant parts of my body.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either atebimetinib with modified gemcitabine and nab-paclitaxel or standard gemcitabine and nab-paclitaxel

Up to approximately 2 years

Follow-up

Participants are monitored for safety, efficacy, and overall survival after treatment

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Atebimetinib
  • GnP

Trial Overview

The study compares a new drug called atebimetinib combined with modified chemotherapy (GnP) against standard GnP chemo alone as first-line treatment for advanced pancreatic cancer. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Atebimetinib + mGnPExperimental Treatment2 Interventions
Group II: GnPActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immuneering Corporation

Lead Sponsor

Trials
2
Recruited
450+

Citations

First-Line Atebimetinib Plus mGnP Yields High 9-Month OS ...

Atebimetinib combined with mGnP showed an 86% 9-month OS rate in pancreatic cancer, surpassing historical SOC data. Atebimetinib's mechanism ...

Atebimetinib (IMM-1-104) + Modified Gemcitabine/Nab- ...

As of the August 26, 2025 data cutoff, the median follow-up for overall survival (OS) was. 9.0 months as estimated by the reverse Kaplan–. Meier ...

Atebimetinib Plus SOC Chemo Improves Survival/Safety in ...

Atebimetinib with gemcitabine and nab-paclitaxel achieved 9-month OS and PFS of 86% and 53%, respectively, in patients with pancreatic cancer in ...

Atebimetinib Combination Shows Promising Survival Data ...

New trial data reveals atebimetinib combined with gemcitabine/nab-paclitaxel significantly improves survival rates in pancreatic cancer patients.

Efficacy and Safety of Combination Therapy With Immune ...

Combining ICIs with gemcitabine and nab‐paclitaxel appears feasible and safe, with signals of improved efficacy compared with chemotherapy alone ...

Release Details

Immuneering Announces Exceptional 64% Overall Survival At 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP.

Encouraging Survival, Safety Data for Atebimetinib Combo ...

Atebimetinib combined with mGnP showed 86% OS and 53% PFS at 9 months, surpassing standard benchmarks in pancreatic cancer. · The combination ...

Novel Drug Promising Clinical Trial

Progression-free survival observed at six months was 70 percent, and 53 percent at nine months. In comparison, the standard of care benchmark ...