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A study of rilvegostomig, cisplatin, and gemcitabine compared to durvalumab and a drug combination for adults with advanced biliary tract 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 individuals with advanced Biliary Tract Cancer, which is a type of cancer that develops in the bile ducts, the tubes that carry bile from the liver to the gallbladder. The purpose of the study is to compare the effectiveness and safety of two different treatment approaches. One group will receive rilvegostomig combined with chemotherapy, while another group will receive durvalumab combined with chemotherapy. Chemotherapy refers to the use of powerful medicines to kill fast-growing cancer cells.

The treatment involves medications administered through an intravenous line, which means the medicine is delivered directly into a vein. Some participants may also be taking infliximab or mycophenolate mofetil as part of their ongoing background care. The study also involves the use of other medicines such as gemcitabine or cisplatin to compare how different drug combinations affect patients with certain levels of the PD-L1 protein, a substance found on some cancer cells that helps the immune system identify them.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and treatment assignment

    After joining the study, an assignment is made to one of two different treatment paths. this decision is made through a process called randomization, which means the treatment is assigned by chance, similar to flipping a coin.

    One path involves receiving rilvegostomig, which is given as an intravenous infusion (delivered directly into a vein through a needle or tube), combined with chemotherapy (medicine used to treat cancer).

    The other path involves receiving durvalumab, also given as an intravenous infusion, combined with chemotherapy.

  2. Step 2

    Treatment administration

    The chemotherapy used in the study includes medications such as gemcitabine and cisplatin, which are administered via intravenous use.

    The rilvegostomig or durvalumab is administered as a solution for infusion into the vein.

    Certain background medications may be used during the study, which include infliximab (given through a vein) and mycophenolate mofetil (taken by mouth).

  3. Step 3

    Monitoring and evaluation

    The effectiveness of the treatment is monitored by observing overall survival, which is the length of time a person remains alive during and after the treatment.

    The study also tracks progression-free survival, which measures the length of time during and after treatment that the cancer does not get worse.

Who can join the trial?

8 criteria

  • You must have a confirmed type of cancer called adenocarcinoma, which is a cancer that starts in the glands, located in the biliary tract (the system of tubes that carries bile). This includes cancers of the bile ducts inside or outside the liver, or cancer of the gallbladder.
  • The cancer must be unresectable, meaning it cannot be removed by surgery, and it must be either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body).
  • You must have not yet received treatment for this advanced stage of the cancer.
  • Your PD-L1 status must be known. PD-L1 is a protein found on certain cells that helps the cancer hide from the immune system. This must be tested using a proper sample of your tumor in a central laboratory.
  • The cancer must be measurable, meaning doctors can clearly see and track the size of the tumors using imaging tests like a CT scan or MRI.
  • You must have a good ECOG Performance Status of 0 or 1. This is a scale used by doctors to measure how well you can perform daily activities; a score of 0 or 1 means you are still quite active and able to function well.
  • You must have had stable health and no significant decline in your ability to function over the 2 weeks before starting the study.
  • Your bone marrow (the part of your body that makes blood cells) and your organ function (how well your vital organs like the liver or kidneys work) must be healthy and adequate.

Who cannot join the trial?

8 criteria

  • Having ampullary carcinoma, which is a type of cancer that starts in the area where the bile duct meets the small intestine.
  • Having already received any systemic therapy, which means medicine that travels through the entire body, to treat advanced or spreading biliary tract cancer that cannot be removed by surgery.
  • Having previously used any treatment that targets the immune-regulatory receptors or mechanisms, which refers to medicines that change how the body's immune system (the system that fights germs and disease) works.
  • Taking any other cancer treatments at the same time, such as chemotherapy (drugs used to kill cancer cells), radiotherapy (using radiation to treat cancer), immunotherapy (treatments that help the immune system fight cancer), biologic therapies, or hormonal therapy, other than the specific medicines being studied in this trial.
  • Having an active or past autoimmune or inflammatory disorder, which are conditions where the body's immune system attacks its own healthy cells, that requires long-term use of steroids or other immunosuppressive treatments (medicines that lower the activity of the immune system).
  • Having active or ongoing interstitial lung disease or pneumonitis, which are conditions involving inflammation or scarring in the lungs.
  • Having serious, ongoing gastrointestinal conditions (problems with the stomach or intestines) that cause diarrhea.
  • Having an active non-infectious skin disease, such as a rash, urticaria (hives), dermatitis (skin inflammation), ulceration (open sores), or psoriasis (a condition causing red, itchy, scaly skin patches), that requires medicine to be taken throughout the body.
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Investigated drugs

  • Rilvegostomig

    is the experimental treatment being tested in this study. It is given through an intravenous infusion and is intended to work alongside chemotherapy to treat advanced biliary tract cancer.

  • Durvalumab

    is a medication used as a comparison in this trial. It is an immunotherapy delivered through an intravenous infusion that helps the body's immune system recognize and attack cancer cells, and it is administered in combination with chemotherapy.

  • Gemcitabine

    is a type of chemotherapy medication given through an intravenous infusion to help kill cancer cells.

  • Cisplatin

    is a chemotherapy medication administered through an intravenous infusion used to treat cancer by interfering with the growth of cancer cells.

  • Infliximab

    is a medication used as background therapy, which is typically used to manage inflammation or immune responses, and is given through an intravenous infusion.

  • Mycophenolate mofetil

    is a medication used as background therapy that works by suppressing the immune system, and it is taken orally.

What is already known about the treatment

  • Gemcitabine

    This medication is an anticancer drug administered through an intravenous infusion into the bloodstream. It is widely used in medical practice to treat various types of cancer, including those found in the bile ducts. The drug works by interfering with the building blocks of DNA, which prevents cancer cells from copying their genetic material and multiplying. It is classified as a chemotherapy agent or antimetabolite.

  • Durvalumab

    This medicine is provided as a concentrated solution for infusion directly into a vein. It is an established immunotherapy used to treat several advanced cancers by helping the body's own immune system recognize and attack cancer cells. At a molecular level, it blocks a specific protein on immune cells that cancer often uses to hide from the body's defenses. It belongs to a class of drugs known as immune checkpoint inhibitors.

  • Infliximab

    This drug is administered through an intravenous injection to treat various inflammatory conditions. It is a well-known medication used to manage diseases like rheumatoid arthritis and Crohn's disease. It works by targeting and neutralizing a specific protein in the body that causes inflammation, thereby reducing swelling and pain. This medication is classified as a monoclonal antibody.

  • Mycophenolate mofetil

    This medication is taken orally in pill or capsule form. It is commonly used in medicine to prevent the body from rejecting transplanted organs and to treat certain autoimmune diseases. The drug works by blocking the production of specific cells that the immune system uses to attack foreign substances or its own tissues. It is classified as an immunosuppressant.

  • Cisplatin

    This is a chemotherapy medication that is given through an intravenous infusion. It is a standard treatment used in medical settings for many different types of solid tumors. The drug works by attaching itself to the DNA inside cancer cells, which causes damage that leads to cell death. It is categorized as a platinum-based chemotherapy agent.

  • Rilvegostomig

    This experimental drug is administered as a solution for infusion through a vein. It is currently being studied in clinical trials and is not yet a standard treatment in medical practice. It is designed to work by blocking specific signals that cancer cells need to grow and develop new blood vessels to feed the tumor. This substance is classified as a targeted therapy.

Investigated diseases

Biliary Tract Cancer - This is a type of cancer that starts in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can develop in the ducts inside the liver or in the ducts outside the liver. The disease typically progresses as abnormal cells grow uncontrollably within these channels. As the cancer grows, it can block the flow of bile through the body. This progression can lead to changes in how the liver functions and how the digestive system processes nutrients.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523085-24-00Protocol codeD702NC00001Estimated enrolment1 100 patientsSponsorAstraZeneca AB

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).