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Phase 3 Study of atebimetinib with gemcitabine and paclitaxel versus gemcitabine and paclitaxel in patients with metastatic pancreatic cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The disease being studied is Metastatic Pancreatic Ductal Adenocarcinoma, a cancer that has spread beyond the pancreas. The treatment under investigation combines an oral medicine called atebimetinib with two chemotherapy drugs given through a vein: gemcitabine and nab-paclitaxel. The chemotherapy drugs work by stopping cancer cells from growing, while the oral medicine targets a specific pathway that helps tumors grow.

The purpose of the study is to determine whether adding the oral medicine to the standard chemotherapy improves overall survival, meaning the length of time patients live after starting treatment. Participants will be randomly assigned to receive either the three‑drug combination or the standard two‑drug chemotherapy alone, and the trial is open‑label so both doctors and participants know which treatment is given.

After enrollment, participants will receive the assigned treatment in cycles that repeat every few weeks, with regular check‑ups to monitor health and any side effects. Blood tests, imaging scans such as CT (a type of X‑ray picture) and questionnaires about daily living will be used to follow progress throughout the study period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After agreeing to join the study, you sign a consent form that explains the purpose of the trial, the treatments you will receive, and your rights as a participant.

  2. Step 2

    Randomization to treatment group

    The study team assigns you to one of two groups: the test group, which receives atebimetinib together with modified gemcitabine and nab-paclitaxel, or the comparator group, which receives only gemcitabine and nab-paclitaxel.

  3. Step 3

    Baseline assessments

    Before starting treatment, you undergo blood tests, imaging scans, and other examinations to document the current status of your disease.

  4. Step 4

    First treatment cycle

    On the first day of the cycle you receive two intravenous (through a vein) infusions:

    gemcitabine 1000 mg per square meter of body surface area (mg/m2) given by infusion,

    nab-paclitaxel 125 mg per square meter (mg/m2) given by infusion.

    If you are in the test group, you also start taking atebimetinib 320 mg by mouth (oral tablet) each day.

  5. Step 5

    Subsequent treatment cycles

    The same set of medications is repeated in each cycle according to the study schedule, which is defined by the trial protocol.

    Each cycle continues until the protocol specifies a stop, such as disease progression, unacceptable side effects, or the end of the planned treatment period.

  6. Step 6

    Regular monitoring visits

    Throughout the study you attend scheduled visits for blood work, imaging, and clinical evaluation to monitor how the disease is responding and to check for side effects.

  7. Step 7

    End of treatment and final follow‑up

    When treatment is stopped, you continue to have follow‑up visits as outlined in the protocol to assess long‑term outcomes and overall survival.

Who can join the trial?

6 criteria

  • Be 18 years of age or older at the time you sign the consent form.
  • Have a confirmed diagnosis of metastatic pancreatic cancer that was identified at least 12 weeks before screening, using the American Joint Committee on Cancer (AJCC) staging system (a method doctors use to describe how far the cancer has spread).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (a scale that measures how well you can perform daily activities; 0 means fully active, 1 means you are restricted but can still do light work).
  • Be treatment‑naive for pancreatic cancer, meaning you have not received any previous systemic anti‑cancer therapy such as chemotherapy.
  • Show measurable disease, meaning at least one tumor can be measured according to RECIST v1.1 criteria (standard rules doctors use to track tumor size).
  • Have adequate organ function, including liver function, blood clotting ability, and other laboratory values, as defined by the study (your kidneys, liver, and blood must be working well enough for the treatment).

Who cannot join the trial?

4 criteria

  • Having a type of pancreatic cancer that is not the usual kind, such as squamous (cancer of flat cells), adenosquamous (cancer with both gland‑like and flat cells), neuroendocrine (also called carcinoid or islet‑cell cancer, which arises from hormone‑producing cells), or acinar (cancer that starts in the cells that make digestive enzymes).
  • Having only localized advanced disease, which means the cancer has grown but has not spread to distant parts of the body.
  • Having cancer that has spread to the central nervous system (CNS) – the brain or spinal cord – and that is causing symptoms, has not been treated, or is getting worse (actively progressing).
  • Being unable to swallow medicines taken by mouth (oral medications).
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Investigated drugs

  • Atebimetinib

    is an oral medicine that targets specific proteins inside cancer cells. In this study it is given as a pill and is combined with other chemotherapy drugs to see if it can help patients with metastatic pancreatic cancer live longer.

  • Gemcitabine

    is a chemotherapy drug that is given through a vein (IV). It works by stopping cancer cells from growing and dividing. In the trial it is used both alone with another chemotherapy drug and together with atebimetinib to compare which approach works better.

  • Paclitaxel (nab‑paclitaxel)

    is a chemotherapy drug that is also given by IV. It is attached to a protein called albumin, which helps it reach the tumor more effectively. In this study it is used together with gemcitabine, and the combination is tested with and without atebimetinib.

What is already known about the treatment

  • Gemcitabine

    This drug is given by intravenous infusion, where the medicine is poured into a vein. It is an approved chemotherapy that is widely used and described in many medical studies. It is mainly used to treat pancreatic, lung, breast and bladder cancers. It works by acting like a building block of DNA, stopping cancer cells from copying their genetic material, and is classified as an antimetabolite chemotherapy.

  • Paclitaxel

    This medicine is also administered by intravenous infusion, delivered directly into the bloodstream. It is a well‑known, approved cancer drug that appears in a large amount of clinical literature. It is used for many solid tumors such as breast, ovarian, lung and pancreatic cancers. It works by binding to cell structures called microtubules and keeping them rigid, which blocks cell division, and it belongs to the taxane class of chemotherapy agents.

  • Atebimetinib

    This medication is taken as an oral tablet that patients swallow with water. It is a newer targeted therapy that has been approved for some skin cancers and is currently being studied for pancreatic cancer. It is intended for cancers that rely on the MAPK signaling pathway. It works by blocking the MEK enzymes that send growth signals inside the cell, and it is classified as a MEK inhibitor, a type of targeted anticancer drug.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma - It is a cancer that begins in the cells lining the pancreatic ducts. Over time it spreads from the pancreas to distant organs such as the liver, lungs, or peritoneum. The disease often grows without obvious symptoms at first, then may cause abdominal discomfort, weight loss, or changes in digestion. As more sites become involved, the tumor burden increases and can affect the normal function of those organs. The spread continues progressively, leading to a broader distribution of cancer throughout the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525617-31-00Protocol codeIMM1104-301Estimated enrolment510 patients

sourced from the EU Clinical Trials Register and site verification

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