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

Trial Status: Active

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

Inclusion Criteria

  • Inclusion 1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. 2. Patients with preciously 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

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Zhong Zheng
Phone: 714-456-7256

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Benjamin R. Roberts
Phone: 913-588-6939

Missouri

Saint Louis
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Siteman Cancer Center at Washington University
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: systems coordinator
Phone: 215-214-1558

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D933AC00001
  • Secondary IDs NCI-2019-06382
  • Clinicaltrials.gov ID NCT03875235