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A Study of BMS-986504 Combined with Nab-Paclitaxel and Gemcitabine for Patients with Untreated Metastatic Pancreatic Cancer with MTAP Gene Deletion

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What is this trial about?

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

This study involves people with pancreatic ductal adenocarcinoma that has spread to other parts of the body and has not been treated yet. Pancreatic ductal adenocarcinoma is a type of cancer that starts in the pancreas, an organ that helps with digestion and blood sugar control. The study specifically looks at tumors that have a particular genetic change called homozygous MTAP deletion, which means a specific gene is missing in both copies within the cancer cells. The treatments being studied include BMS-986504, which is also known as MRTX1719, along with two other cancer medicines called nab-paclitaxel and gemcitabine. Some people in the study will receive BMS-986504 combined with nab-paclitaxel and gemcitabine, while others will receive placebo combined with nab-paclitaxel and gemcitabine. BMS-986504 is given as a tablet by mouth, while nab-paclitaxel and gemcitabine are given through a vein.

The purpose of the study is to test whether BMS-986504 combined with nab-paclitaxel and gemcitabine can help people live longer and delay the time until the cancer gets worse compared to placebo combined with nab-paclitaxel and gemcitabine. The study will also look at whether the combination treatment can shrink tumors and control tumor growth. People joining the study must have their cancer confirmed through tissue samples and must have evidence of the MTAP deletion in their tumor. The cancer must have spread to other parts of the body with at least one area that can be measured on scans.

During the study, people will be randomly assigned to receive either BMS-986504 or placebo, both given together with nab-paclitaxel and gemcitabine. The study will track how long it takes for the cancer to worsen on scans and how long people survive. Researchers will also measure how much tumors shrink, how long any shrinkage lasts, and how many people experience tumor control or shrinkage. People in the study must not have received any cancer treatment for their spread disease before joining, although they may have received up to one cycle of nab-paclitaxel and gemcitabine before being assigned to a treatment group.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is similar to flipping a coin and ensures fairness in the study.

    One group will receive BMS-986504 (also called MRTX1719) combined with nab-paclitaxel (a protein-bound form of the chemotherapy drug paclitaxel) and gemcitabine (another chemotherapy drug).

    The other group will receive a placebo (an inactive substance with no medication) combined with nab-paclitaxel and gemcitabine.

    You will not know which group you are assigned to during the study.

  2. Step 2

    Receiving oral medication

    You will take either BMS-986504 tablets or placebo tablets by mouth, depending on your assigned group.

    The tablets are film-coated, which means they have a smooth outer layer for easier swallowing.

    You will need to take these tablets according to the schedule provided by the study staff.

  3. Step 3

    Receiving intravenous chemotherapy

    Regardless of your group assignment, you will receive two chemotherapy medications through a vein: nab-paclitaxel and gemcitabine.

    Nab-paclitaxel is a form of paclitaxel that is bound to albumin, a protein that helps deliver the medication to cancer cells.

    Gemcitabine is a chemotherapy drug that interferes with cancer cell growth.

    These medications will be administered by infusion into your vein at the study site.

  4. Step 4

    Regular monitoring and assessments

    Throughout the study, you will undergo regular medical assessments to monitor your condition and response to treatment.

    Imaging scans will be performed periodically to evaluate whether the cancer is growing, shrinking, or staying the same size.

    These assessments help determine the effectiveness of the treatment and monitor for any changes in your disease.

  5. Step 5

    Continuation of treatment

    You will continue receiving the assigned treatment combination according to the study protocol.

    The duration of treatment will depend on how your body responds to the therapy and whether your disease remains stable or improves.

    Treatment may continue for an extended period as long as it is beneficial and tolerable for you.

  6. Step 6

    Study completion

    The study is expected to continue until approximately May 2029.

    Your participation may end earlier or later depending on your individual response to treatment and overall health status.

    Final assessments will be conducted to evaluate the overall outcomes of the treatment you received.

Who can join the trial?

5 criteria

  • You must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma, which means cancer that started in the tubes of the pancreas and has spread to other parts of the body. This diagnosis must be confirmed by examining tissue or cells under a microscope.
  • Your tumor tissue must show a specific genetic change called homozygous MTAP deletion or MTAP loss. This means that both copies of a particular gene called MTAP are missing or not working in your cancer cells.
  • You must have cancer that has spread to other parts of the body with at least one tumor that can be measured on scans according to specific measurement rules called RECIST v1.1.
  • You must not have received any previous cancer treatment for your cancer that has spread, meaning this would be your first treatment for the advanced disease. However, you may have received up to one cycle of standard treatment with nab-paclitaxel and gemcitabine, which are chemotherapy medicines, before joining the study.
  • You must be older than 18 years of age at the time you sign the consent form to participate in the study.

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria information, it is not possible to list specific conditions or situations that would prevent participation in this clinical trial
  • Typically, exclusion criteria may include things like other serious medical conditions, certain medications being taken, previous treatments, or laboratory test results that fall outside acceptable ranges, but these specific details are not available in the provided information
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Investigated drugs

  • BMS-986504

    is an investigational medication being tested in combination with other cancer drugs. This medication is specifically being studied for patients with a certain type of pancreatic cancer that has a specific genetic characteristic called homozygous MTAP deletion. The purpose of testing this medication is to see if it can help slow down the growth and spread of cancer and help patients live longer when used together with other treatments.

  • Nab-paclitaxel

    is a chemotherapy medication used to treat various types of cancer, including pancreatic cancer. It works by stopping cancer cells from dividing and growing. This medication is delivered in a special form that uses tiny particles to help the drug reach cancer cells more effectively.

  • Gemcitabine

    is a chemotherapy medication commonly used to treat pancreatic cancer and other types of cancer. It works by interfering with the growth of cancer cells, which slows down or stops their spread in the body. This medication is often used in combination with other cancer treatments.

What is already known about the treatment

BMS-986504 – BMS-986504 is an investigational medication currently being studied in clinical trials for the treatment of metastatic pancreatic cancer that has a specific genetic change called homozygous MTAP deletion. This experimental drug is given in combination with two other cancer medications, Nab-paclitaxel and Gemcitabine, and is being tested to see if it can slow down cancer growth and help patients live longer compared to standard treatment alone. The medication targets a molecular weakness created by the missing MTAP gene, which makes cancer cells more vulnerable to certain treatments. It is still in the research phase and has not yet been approved for regular medical use.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that starts in the cells lining the ducts of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar control. The cancer begins when cells in these ducts start growing abnormally and uncontrollably. As the disease progresses, the cancer cells spread beyond the pancreas to other parts of the body, such as the liver, lungs, or distant lymph nodes, which is called metastasis. This spreading occurs through the bloodstream or lymphatic system. The tumor can grow larger in the pancreas itself while also forming new tumors in distant organs. Symptoms may include abdominal pain, weight loss, jaundice (yellowing of the skin and eyes), loss of appetite, and digestive problems as the disease advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522598-12-00Protocol codeCA240-0030Estimated enrolment470 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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