A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers
Details
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
Eligibility
You can join if...
Inclusion Criteria
Participants must be 18 years of age or older at the time of screening
Participants must have histologically confirmed, unresectable advanced or metastatic biliary tract cancer including choloangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma, and ampulla of Vater (AoV) carcinoma
Participants must have body weight of greater than 30 kg
Exclusion Criteria
Participants with known allergy or hypersensitivity to any of the study intervention or any of the study intervention excipients
Participants who have participated in another clinical study with a study intervention administered in the last 3 months
Participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to use effective birth control from screening to 90 days after the last dose of study intervention with durvalumab or up to the end of the period specified in the US package insert for each relevant gemcitabine-based chemotherapy, whichever is longer