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

3 1 1 1

What is this study about?

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.

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 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 baseline assessments

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

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 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 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 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 Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
ELBLANDKLINIKEN Stiftung & Co. KG Riesa Germany
Centre Hospitalier Universitaire De Nantes Nantes France
University Hospital Olomouc Olomouc Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Technische Universität München – Klinikum Rechts der Isar Munich Germany
Hpqftqt Pxgsp Jdwi Mwfwpk Lyon France
Chgiweb Uukkumnmqsy Dx Nzrprto Madrid Spain
Ijupqixl Pwbxswkeayndmnc Ckvrwk Cdjnvt Marseille France
Hrmfygla Vziq dkcxgoce Barcelona Spain
Fjxybypm Tvhmzvduudh nweduwoto Prague Czechia
Vymfym duh Rjqkb Ukyalxevnx Hrclslvd Sevilla Spain
Hfhabkuh Cwrkol Do Bwjhhmllm Barcelona Spain
Sqjwblurvuly Hcjphjkgf Glvg Heilbronn Germany
Fvreyher Noaiekixm Btge Brno Czechia
Bkrnobhb Ugbckcpftt Hhglcera Cgdlpj Besançon France
Kftmgtxv dcb Ubcjhyqyzfgw Mwpribqe Agx Munich Germany
Cnxzoi Lsau Bkwwba Lyon France
Udzfzulgqa Os Avswgyv Edegem Belgium
Clhyux Hqlzqvqfsqv Uxkdqkqmxnofh Dl Ppawclqi Poitiers France
Kcivfuhlrztq Mlzlqoeqffumulnzv gfkie Hamburg Germany
Hbytdnij Uctdnbjhnfpiv 1s Dg Oexewcj Madrid Spain
Iwnqvoxa Canuzv Ddmrlyuzugoytveme L'hospitalet De Llobregat Spain
Fboufysbv Pqlz Lj Ixzktqkdbborp Bogvfojuk Dge Hlyrpaap Uitnjkvmwkqcq Lo Psz Madrid Spain
Iwwojl Bonheiden Belgium
Pvuscm Sual Skorzewo Poland
Nevblegh Igotuoky Osaxllszh Ipy Muqwb Sdlmlquzzalismgskvenusvzhnve Ixebmeck Bmpaiske Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.10.2026
Czechia Czechia
Not yet recruiting
01.10.2026
France France
Not yet recruiting
01.10.2026
Germany Germany
Not yet recruiting
01.10.2026
Poland Poland
Not yet recruiting
01.10.2026
Spain Spain
Not yet recruiting
01.10.2026

Trial locations

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.

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 ID:
2026-525617-31-00
Protocol code:
IMM1104-301
NCT ID:
NCT07562152
Trial Phase:
Therapeutic confirmatory (Phase III)

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