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Study of pembrolizumab with gemcitabine and cisplatin as first treatment for patients with advanced or inoperable bile duct 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 Biliary Tract Carcinoma, a type of cancer that affects the bile ducts and gallbladder. The research evaluates the effectiveness of combining three medications: pembrolizumab (also known as KEYTRUDA), gemcitabine, and cisplatin in treating advanced or inoperable biliary tract cancer. Some participants will receive these medications, while others will receive gemcitabine and cisplatin with a placebo instead of pembrolizumab.

The purpose of this research is to determine if adding pembrolizumab to the standard treatment of gemcitabine and cisplatin helps patients live longer. The medications are given through intravenous infusion, which means they are administered directly into a vein. Pembrolizumab or placebo is given along with gemcitabine and cisplatin according to a specific schedule throughout the treatment period.

This is a double-blind study, which means neither the patients nor their doctors will know whether they are receiving pembrolizumab or placebo. The treatment will continue for several months, with regular medical check-ups to monitor the patient's health and how well the treatment is working. The study team will track how the cancer responds to treatment and any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to receive either pembrolizumab or a placebo, along with gemcitabine and cisplatin

    All medications will be given through an intravenous infusion (delivered directly into your vein)

  2. Step 2

    Treatment schedule

    You will receive treatment with gemcitabine and cisplatin, combined with either pembrolizumab or placebo

    The treatment will continue as long as your condition does not worsen and no unacceptable side effects occur

    Regular medical assessments will monitor how your body responds to the treatment

  3. Step 3

    Monitoring and assessments

    Your tumor status will be regularly evaluated using imaging scans

    The medical team will assess your overall health and monitor any side effects

    Blood tests will be performed to check your organ function

  4. Step 4

    Treatment duration

    The study is expected to continue until February 2025

    Your participation duration will depend on how your body responds to the treatment

    You may continue receiving treatment as long as it provides benefit and is well-tolerated

  5. Step 5

    Safety monitoring

    Any side effects or health changes will be carefully documented

    The medical team will regularly assess if it is safe for you to continue treatment

    Treatment may be adjusted or stopped if necessary for your safety

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of advanced biliary tract cancer (cancer in the bile ducts or gallbladder) that is either spread to other parts of the body or cannot be surgically removed
  • Must have tumors that can be measured using special imaging criteria called RECIST 1.1 (a standardized way to measure if tumors are growing, shrinking, or staying the same)
  • Can participate even with a history of hepatitis B or hepatitis C (liver infections) if other study requirements are met
  • Must be able to provide a tissue sample from the tumor, either from previous procedures or through a new biopsy (removal of a small piece of tumor tissue)
  • Must have a life expectancy of more than 3 months
  • Must have properly functioning organs
  • Must be an adult (18 years or older)
  • Can be either male or female

Who cannot join the trial?

14 criteria

  • Previous treatment with immunotherapy (treatments that help your immune system fight cancer)
  • Known active hepatitis B or C infection (liver infections)
  • Active autoimmune disease (condition where your immune system attacks healthy cells) requiring systemic treatment
  • History of organ transplant
  • Brain metastases (cancer spread to the brain) that are not stable or require steroids
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding women
  • Known allergy or sensitivity to study medications
  • Serious heart conditions in the past 6 months
  • Other active cancers requiring treatment (except non-melanoma skin cancer or cervical cancer in situ)
  • Severe kidney or liver problems
  • HIV infection (human immunodeficiency virus) that is not well controlled
  • Mental conditions that could interfere with study participation
  • Use of systemic corticosteroids (anti-inflammatory medications) or other immune-suppressing drugs
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Investigated drugs

Pembrolizumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body's natural defenses to work better against the disease. Gemcitabine is a chemotherapy medication that works by interfering with the growth of cancer cells. It prevents cancer cells from making and repairing DNA, which they need to grow and multiply. Cisplatin is also a chemotherapy medication that works by damaging the DNA of cancer cells. This prevents the cancer cells from dividing and causes them to die. It is often used in combination with other cancer treatments to increase their effectiveness. These medications are being studied in combination to treat advanced biliary tract cancer (cancer of the bile ducts). While gemcitabine and cisplatin are standard treatments for this type of cancer, adding pembrolizumab might help improve the treatment's effectiveness.

What is already known about the treatment

  • Pembrolizumab

    A prescription medication administered through intravenous infusion that belongs to the class of immunotherapy drugs known as PD-1 inhibitors. This monoclonal antibody works by helping the immune system detect and fight cancer cells by blocking the PD-1 pathway, which normally prevents T-cells from attacking other cells in the body. It is currently approved for treating various types of cancer, including being studied for biliary tract carcinoma in combination with chemotherapy agents.

  • Gemcitabine

    An intravenous chemotherapy medication belonging to the antimetabolite class of drugs that works by interfering with cancer cell DNA production and stopping tumor growth. It is commonly used in combination with other chemotherapy drugs to treat various types of cancer, including biliary tract carcinoma, and acts by replacing one of the building blocks of cellular DNA, causing cancer cell death.

  • Cisplatin

    A platinum-based chemotherapy drug administered intravenously that works by binding to cancer cell DNA, preventing cell division and leading to cell death. It belongs to the platinum-containing compounds class and is widely used in combination therapy for various cancers, including biliary tract carcinoma, though it may cause significant side effects such as kidney problems and hearing loss.

Investigated diseases

Biliary Tract Carcinoma - A type of cancer that develops in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine. This cancer begins in the cells that line the bile ducts, either inside or outside the liver. The disease typically develops slowly and may start with the abnormal growth of bile duct cells. As it progresses, it can cause the bile ducts to narrow and block the normal flow of bile. The cancer can occur in any part of the bile duct system, including the ducts inside the liver (intrahepatic), outside the liver (extrahepatic), or in the area where the ducts meet to drain into the small intestine.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506657-38-00Protocol codeMK-3475-966Estimated enrolment1 040 patientsSponsorMerck Sharp & Dohme LLC

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