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TOPAZ-1: Durvalumab plus gemcitabine/cisplatin vs placebo plus gemcitabine/cisplatin in first-line advanced biliary tract cancer

2023-507405-34-00Phase 3Authorised

Sponsor
AstraZeneca
Start
Jun 2024
Modality
PD-1/PD-L1 Inhibitors → Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
17
01

Overview

Phase 3, randomised, double-blind trial in biliary cancer, cholangiocarcinoma (CCA) and gallbladder cancer comparing Durvalumab + gemcitabine + cisplatin with Placebo + gemcitabine + cisplatin (2 arms). Primary endpoint: Overall survival. Planned start Jun 2024; status: authorised.

02

Drugs

durvalumab
03

Conditions

biliary cancercholangiocarcinoma (CCA)gallbladder cancer

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