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

ClinicalTrials.gov Identifier
NCT03875235
Institution Name
AstraZeneca
Institution Phone
(877) 240-9479
Institution Website
https://astrazeneca.com
Principal Investigator
AstraZeneca Clinical Study Information Center
Principal Investigator Phone
(877) 240-9479
Principal Investigator Email
information.center@astrazeneca.com
Additional Principal Investigators
Please refer to Clinicaltrial.gov and contact AstraZeneca Cancer Study Locator Service (1-877-400-4656 AstraZeneca@emergingmed.com)
Study Coordinator
TBD
Additional Study Coordinators
Please refer to Clinicaltrial.gov and contact AstraZeneca Cancer Study Locator Service (1-877-400-4656 AstraZeneca@emergingmed.com)
Study Overview
This is a Phase III Study of Durvalumab (Immunotherapy) in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers. Chemotherapy (Gemcitabine plus Cisplatin) is the standard of care for advanced biliary tract cancer.
Enrollment Information
474
Study Start Date
20190416
Study End Date
20220325
Study Purpose

  • The purpose of the study is to find out if durvalumab (immunotherapy) in combination with gemcitabine plus cisplatin will work for the treatment of advanced biliary tract cancers.
Inclusion Criteria

  • Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.

  • Patients with preciously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.

  • 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.

  • WHO/ECOG PS of 0 or 1
Exclusion Criteria

  • History of another primary malignancy

  • Brain metastases or spinal cord compression

  • Uncontrolled intercurrent illness

  • Major surgical procedure within 28 days prior to the first dose of IP

  • Prior locoregional therapy such as radioembolization
Financial Assistance Available
Yes