A Global Phase III Study of Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer

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

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 study

5. Prior locoregional therapy such as radioembolization