RecruitingPHASE3INTERVENTIONAL

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

This clinical trial is looking at a new treatment approach for pancreatic cancer that has spread to other parts of the body. It combines a new drug called atebimetinib with a commonly used chemotherapy called GnP. Researchers want to find out if this combination is more effective than GnP chemotherapy on its own for patients who are starting their first treatment for this type of cancer. The main goal is to see if patients live longer with the new combination and to check for any side effects. This is a Phase 3 study, meaning it's a later stage of testing, comparing the new treatment against the current standard care.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Immuneering Corporation

Enrolment target

510

Start

05 Jun 2026

Estimated completion

01 Feb 2029

Pancreatic Cancer Pancreatic Cancer Metastatic PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Ductal Adenocarcinoma Pancreatic Adenocarcinoma Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma

What is this study about?

This study is for people who have pancreatic cancer that has spread to other parts of the body. This is often called 'metastatic' cancer. The aim is to see if a new medicine, called atebimetinib, can improve treatment when given alongside a standard chemotherapy called GnP.

Pancreatic cancer treatment often involves chemotherapy to help slow down the disease. In this trial, researchers are comparing the usual GnP chemotherapy against a combination of atebimetinib plus a slightly adjusted schedule of GnP. They want to find out if this new combination helps patients live longer and if it's safe. This is a 'first-line' treatment study, which means it's for people who haven't had other cancer treatments yet.

By taking part, you would be helping doctors understand if this new combination could become a better treatment option in the future. The study is a 'Phase 3' trial, which is the final stage of testing a new treatment before it can be considered for wider use.

Key takeaways

This study is testing a new drug (atebimetinib) with chemotherapy for pancreatic cancer that has spread.
It's for people starting their first treatment for this type of cancer.
You would be randomly assigned to either the new combination or standard chemotherapy.
The main goal is to see if the new combination helps people live longer and is safe.
Taking part means regular hospital visits, tests, and careful monitoring.

Who may be eligible?

To join this study, you must be at least 18 years old and have a confirmed diagnosis of pancreatic cancer that has spread. This means the cancer has moved from the pancreas to other areas of your body. Importantly, you must not have received any previous cancer treatment for your pancreatic cancer.

Your general health also needs to be good enough to take part. This will be checked by the study doctors through various tests. You must also have cancer that can be measured, so doctors can see if the treatment is working.

There are also some reasons why you might not be able to join. For example, if your cancer is only in the local area around the pancreas and hasn't spread, or if you have certain other types of pancreatic cancer that are not the focus of this study. You also wouldn't be able to join if you can't swallow medicines whole, or if you have untreated brain tumours that are causing symptoms or getting worse.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your doctor confirmed you have pancreatic cancer that has spread?
Have you NOT had any other anti-cancer treatment for your pancreatic cancer yet?
Are you able to swallow tablets whole?
Are you generally well enough to manage daily activities without much help?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will receive the new medicine atebimetinib along with chemotherapy (gemcitabine and nab-paclitaxel, with a slightly adjusted schedule). The other group will receive the standard chemotherapy (gemcitabine and nab-paclitaxel) on its own. You won't be able to choose which group you are in, and neither will your doctor.

The study involves regular visits to the hospital for your treatment, blood tests, scans, and check-ups to monitor your health and how you're responding to the treatment. You would take the new medicine atebimetinib as tablets, if you're in that group, and the chemotherapy would be given intravenously (into a vein). The study team will explain the full schedule of visits and treatments. You will be followed up by the study team for some time after your main treatment ends to see how you are doing. The total duration of your involvement, including follow-up, will be explained by the study team.

Potential risks and benefits

Potential benefits of taking part could include receiving a new treatment that might be more effective than current standard care, and closer monitoring of your health during the study. However, there's no guarantee the new treatment will work for you, and it may not be better than existing treatments. Potential risks include side effects from the new drug atebimetinib and the chemotherapy, which will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (63)

Clearview Cancer Institute
Verified postcode
Huntsville, United States· Recruiting
City of Hope
Verified postcode
Phoenix, United States· Recruiting
City of Hope
Verified postcode
Duarte, United States· Recruiting
University of California San Diego
Verified postcode
San Diego, United States· Recruiting
Poudre Valley Health Care, Inc
Verified postcode
Fort Collins, United States· Recruiting
Rocky Mountain Cancer Centers
Verified postcode
Lone Tree, United States· Recruiting
Medical Oncology Hematology Consultants
Verified postcode
Newark, United States· Recruiting
Hematology Oncology Associates of the Treasure Coast
Verified postcode
Port Saint Lucie, United States· Recruiting
Florida Cancer Specialists - South
Verified postcode
Sarasota, United States· Recruiting
Florida Cancer Specialists - North
Verified postcode
St. Petersburg, United States· Recruiting
Florida Cancer Specialists - East
Verified postcode
West Palm Beach, United States· Recruiting
Piedmont Cancer Institute
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is 'metastatic pancreatic cancer'?

This means the pancreatic cancer has spread from where it started to other parts of your body.

What is 'first-line treatment'?

This is the first treatment you receive for your cancer, before any other specific anti-cancer drugs have been tried.

What does 'randomised' mean?

It means you will be put into one of two treatment groups by chance, like drawing lots or flipping a coin. Neither you nor your doctor can choose the group.

What is a 'Phase 3' study?

This is the final stage of testing a new treatment before it can be considered for wider use. It compares the new treatment against the best current treatment.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving.

How to find out more

Immuneering Study Team

clinicaltrials@immuneering.com 860-321-1302 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.