Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

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About the study

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

EXCLUSION CRITERIA

  • Inclusion
    1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
    2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
    3. Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
    4. WHO/ECOG PS of 0 or 1

    Exclusion


    1. History of another primary malignancy
    2. Brain metastases or spinal cord compression
    3. Uncontrolled intercurrent illness
    4. Major surgical procedure within 28 days prior to the first dose of IP.
    5. Prior locoregional therapy such as radioembolization

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    Study Locations

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    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition
    Biliary Tract Neoplasms
    Age (in years)
    18 - 130
    Phase
    Phase 3
    Participants needed
    810
    Est. Completion Date
    Mar 31, 2025
    Treatment type
    Interventional

    Sponsor
    AstraZeneca
    ClinicalTrials.gov identifier
    NCT03875235
    Study number
    D933AC00001

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