AuthorisedTherapeutic confirmatory (Phase III)Interventional

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)

Pancreatic cancer can be difficult to treat, especially when it has spread to other parts of the body (known as metastatic cancer). The usual treatment is chemotherapy, such as a combination of gemcitabine and nab-paclitaxel. This study, called MAPKeeper 301, is testing whether adding a new targeted drug called atebimetinib to chemotherapy works better than chemotherapy by itself. Researchers want to find out if this new combination can help people live longer and maintain a good quality of life. Participants will be placed into one of two groups: one receives standard chemotherapy, and the other receives the new drug combination. The study is open to adults aged 18 and over with advanced pancreatic ductal adenocarcinoma who meet specific health criteria.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Immuneering Corp.

Enrolment target

400

Start

17 Sep 2026

Metastatic Pancreatic Ductal Adenocarcinoma

What is this study about?

Pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer. When it is metastatic, it means cancer cells have spread from the pancreas to other organs or tissues. Finding treatments that can slow the disease down and help people live longer is an urgent priority for doctors and researchers.

Currently, many patients are offered a combination of two chemotherapy drugs called gemcitabine and nab-paclitaxel. While this can help control the cancer, doctors are searching for ways to make treatment more effective. In this Phase 3 trial, researchers are testing a new medicine called atebimetinib. Atebimetinib is designed to target specific signals inside cancer cells to help stop them from growing.

This trial is comparing two approaches. One group of patients will receive the standard chemotherapy drugs. The other group will receive atebimetinib along with a modified chemotherapy plan. By comparing these two groups, doctors can clearly see if adding the new medicine brings real benefits.

Researchers will closely track how long patients live and how well the treatment controls their cancer. They will also ask patients to complete questionnaires to measure their everyday well-being and quality of life throughout the study.

Key takeaways

Tests a new medicine, atebimetinib, combined with chemotherapy for advanced pancreatic cancer.
A Phase 3 study comparing the new drug combination against the current standard chemotherapy.
Aims to find out if the new treatment helps people live longer with a good quality of life.
Open to adults aged 18 and over diagnosed with metastatic pancreatic ductal adenocarcinoma.
Participation is entirely voluntary, with close monitoring from hospital specialists.

Who may be eligible?

This trial is for adults aged 18 and older who have been diagnosed with metastatic pancreatic ductal adenocarcinoma. This means the cancer started in the pancreas and has spread to other areas of the body.

To take part, participants usually need to be well enough to carry out everyday activities, as chemotherapy can be physically demanding. Doctors will check that your heart, liver, and kidneys are working well enough to receive treatment safely.

People who have already had certain previous treatments for advanced pancreatic cancer, or who have other serious ongoing health conditions, may not be able to join. A doctor at the study hospital will review your medical history and test results to confirm if this trial is right for you.

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.

I am aged 18 or older.
I have been diagnosed with metastatic pancreatic ductal adenocarcinoma (cancer that has spread).
I am well enough to attend regular hospital appointments for treatment and tests.
I have discussed my previous cancer treatments with my medical team.
I am willing to undergo scans, blood tests, and complete quality-of-life surveys.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned by chance (randomised) to one of two treatment groups. One group receives the standard chemotherapy drugs via a drip into a vein. The other group receives the new medicine, atebimetinib, alongside chemotherapy. You will attend regular hospital appointments to receive your treatment, have blood tests, and undergo body scans (such as CT scans) to check how the cancer is responding. You will also be asked to complete simple surveys about your symptoms and daily well-being. Treatment usually continues for as long as it helps you and side effects remain manageable, followed by regular check-ins with the research team.

Potential risks and benefits

Taking part may help control your cancer, and the results could help future patients facing the same condition. However, there is no guarantee that the new combination will work better than standard care. You may experience side effects from the chemotherapy, the new medicine, or both; these can include tiredness, nausea, low blood counts, or digestive upset. Your care team will monitor you closely and offer treatments to help manage any discomfort. Taking part is completely voluntary, and you can withdraw from the study at any time without your normal medical care being affected.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Czechia
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Unverified
Hungary
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Unverified
Belgium
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Unverified
Poland
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Unverified
Germany
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Unverified
France
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Unverified
Italy
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Unverified
Romania

Common questions

What is a Phase 3 trial?

A Phase 3 trial is a large study that tests whether a new treatment works better, or has fewer side effects, than the current standard treatment used by doctors.

Will I definitely receive the new medicine?

No. A computer randomly decides whether you receive standard chemotherapy or the new combination. This ensures the results of the study are fair and unbiased.

Do I have to pay to take part in this trial?

No. In the UK, study medicines and trial-related tests are provided free of charge, and some travel expenses may be covered.

Can I leave the study if I change my mind?

Yes. You can leave the study at any point. Your decision will never affect the quality of NHS care you receive.

Will this treatment cure my cancer?

Metastatic pancreatic cancer is very difficult to cure. The primary goal of this study is to control the cancer, help patients live longer, and maintain their quality of life.