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A study of pumitamig and a drug combination versus nivolumab and a drug combination for patients with untreated advanced or metastatic stomach or esophageal cancer

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What is this trial about?

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

This study focuses on patients with previously untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma. This refers to a type of cancer found in the stomach, the area where the esophagus meets the stomach, or the lower part of the esophagus that has spread to other parts of the body. The purpose of the study is to compare the effectiveness and safety of different treatment combinations for this cancer.

Participants may receive a combination of the study drug pumitamig (also referred to as BNT327) and chemotherapy. The chemotherapy medications involved include oxaliplatin, fluorouracil, and capecitabine, sometimes used alongside calcium folinate. In the first part of the study, two different doses of pumitamig are tested to see which one works best. In the second part, the more effective dose is compared to a standard treatment consisting of nivolumab and chemotherapy.

The study is conducted in stages. Initially, the goal is to determine which dose of the new medicine is most effective at controlling tumor growth while minimizing side effects. Following this, the selected dose is evaluated to see if it can extend progression-free survival, which is the length of time a patient lives with the disease without it getting worse, and overall survival, which is the total length of time a patient remains alive.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in phase 2

    You will be assigned to one of two groups to receive different doses of pumitamig, which is given through an intravenous infusion (a liquid medicine delivered directly into a vein).

    The two doses available are 20 mg/ml or 50 mg/ml of pumitamig.

    The pumitamig will be used in combination with chemotherapy, which is a type of medicine used to treat cancer.

    The chemotherapy medicines involved include oxaliplatin (given as an infusion), fluorouracil (given as an injection), and capecitabine (taken by mouth).

    calcium folinate (an injection) may also be administered.

    The purpose of this stage is to determine which dose of pumitamig is more effective at controlling tumor growth and has fewer side effects.

  2. Step 2

    Participation in phase 3

    Once the most effective dose of pumitamig is identified, you may be assigned to a group that receives that specific dose combined with chemotherapy.

    This group will be compared against a group receiving nivolumab (an infusion) combined with chemotherapy.

    The goal of this stage is to see if the pumitamig and chemotherapy combination works better than the current standard treatment in controlling cancer growth.

    The effectiveness of the treatment is monitored by checking how long it takes for the cancer to grow again using radiographic imaging, such as ct scans (special pictures of the inside of the body).

Who can join the trial?

9 criteria

  • You have not yet received systemic treatment, which means medicine that travels through your entire body (like chemotherapy) to treat your cancer.
  • Your cancer is advanced or metastatic, meaning the cancer has grown or spread beyond where it first started.
  • Your cancer type is gastric cancer (stomach cancer), gastroesophageal junction cancer (where the esophagus meets the stomach), or esophageal adenocarcinoma (a type of cancer starting in the esophagus).
  • The cancer has been confirmed by a doctor using a biopsy (taking a small sample of tissue), endoscopy (using a tiny camera to look inside the body), or imaging (such as a scan).
  • Your cancer tests show PD-L1 levels of 1 or higher, which is a specific protein found on some cancer cells.
  • Your cancer is HER2-negative, meaning the cancer cells do not have high amounts of a specific protein that helps cancer grow.
  • Your cancer is measurable, which means a doctor can clearly see the size and location of the tumors on medical scans using standard measurement rules called RECIST.
  • You can be either male or female.
  • You must be within the age range specified for this study.

Who cannot join the trial?

10 criteria

  • You cannot participate if you have cancer that has spread to the central nervous system, which is the part of the body that includes the brain and spinal cord, unless it has been properly treated and your nerve functions have returned to normal for at least 2 weeks.
  • You cannot participate if you are taking corticosteroids, which are medicines used to reduce swelling or inflammation, unless you have stopped them or your dose has been stable or decreasing at a low level for at least 2 weeks.
  • You cannot participate if you have significant heart disease, such as a heart attack (damage to the heart muscle due to lack of blood), unstable angina (chest pain that occurs unpredictably or at rest), arterial thrombosis (a blood clot in an artery), or a stroke (a sudden interruption of blood flow to the brain) within the last 6 months.
  • You cannot participate if you have uncontrolled high blood pressure, meaning your blood pressure readings remain high despite taking the best possible medicine.
  • You cannot participate if you have congenital long QT syndrome, which is an electrical problem in the heart that can cause irregular heartbeats that you are born with.
  • You cannot participate if you have major blood clotting disorders, such as hemophilia, which is a condition where the blood does not clot normally.
  • You cannot participate if you have a history of deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot that travels to the lungs), or other significant blood clots within the last 3 months, unless you have been fully treated or are taking medicine to prevent clots.
  • You cannot participate if you have had an abdominal fistula (an abnormal connection or tunnel between organs in the abdomen) or a gastrointestinal perforation (a hole made in the wall of the stomach or intestines) within the last 6 months.
  • You cannot participate if you have had major surgery, an open biopsy (the removal of tissue through a large incision for testing), or a significant injury within the last 28 days.
  • You cannot participate if you are expected to need major surgery while you are taking part in the study.
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Investigated drugs

  • Calcium folinate

    is a medication used in this trial to support the body during treatment.

  • Nivolumab

    is a type of immunotherapy used as a comparison treatment to help the immune system recognize and fight cancer cells.

  • Pumitamig

    is an investigational medicine being tested in combination with chemotherapy to see how well it helps control cancer growth.

  • Oxaliplatin

    is a chemotherapy drug used to help kill cancer cells.

  • Fluorouracil

    is a chemotherapy drug used to help kill cancer cells.

  • Capecitabine

    is a chemotherapy medication taken by mouth to help treat cancer.

What is already known about the treatment

  • Calcium folinate

    This medication is administered as a solution through an injection. It is a well-established substance used in medical practice to help reduce the harmful side effects of certain chemotherapy drugs. It works by protecting healthy cells from the toxic effects of treatment by supporting essential chemical processes within the cells. This drug is classified as a vitamin derivative used to support cell function during cancer therapy.

  • Nivolumab

    This medication is given as a liquid concentrate through an intravenous infusion into the vein. It is a widely used, approved treatment for various types of cancer. The drug works by blocking a specific protein on immune cells that prevents them from attacking cancer, thereby helping the body's own immune system recognize and fight the tumor. It is classified as an immunotherapy agent.

  • Pumitamig

    This medication is provided as a concentrate for intravenous infusion into the bloodstream. It is currently being studied in clinical trials to determine its effectiveness in treating advanced cancers. The drug works by targeting specific proteins on the surface of cancer cells to help trigger an immune response against them. It is classified as an antibody-based therapy.

  • Oxaliplatin

    This medication is administered as a solution through an intravenous infusion. It is a standard, widely used component in many chemotherapy regimens. It works by binding to the DNA inside cancer cells, which prevents the cells from copying their genetic material and causes them to die. This drug is classified as a platinum-based chemotherapy agent.

  • Fluorouracil

    This medication is given as a solution through an injection or infusion. It is a common and well-known medicine used to treat many types of cancer. It works by interfering with the production of DNA and RNA, which stops cancer cells from growing and dividing. This substance is classified as an antimetabolite chemotherapy drug.

  • Capecitabine

    This medication is taken orally in pill form. It is an established and commonly used treatment for several types of solid tumors. Once inside the body, it is converted into an active form that interferes with the DNA production of cancer cells to stop their growth. It is classified as an oral chemotherapy agent.

Investigated diseases

Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus - This is a type of cancer that begins in the glandular cells that line the inner surfaces of the stomach, the area where the esophagus meets the stomach, or the esophagus. The disease occurs when these cells grow uncontrollably and form abnormal masses. In advanced or metastatic stages, the cancer has spread from its original location to other parts of the body. As it progresses, the tumor cells continue to multiply and may invade nearby tissues or travel through the blood and lymphatic systems.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-523263-37-00Protocol codeCA2660004Estimated enrolment690 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).