TOPAZ-1 — Durvalumab Plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer

Phase 3 · 2022 · Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer

Design

Double-blind trial randomizing untreated advanced biliary tract cancer to durvalumab or placebo added to gemcitabine-cisplatin.

Population

Previously untreated, unresectable or metastatic biliary tract cancer (intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer).

Primary Endpoint

overall survival (OS)

Key Result

Median OS 12.8 vs 11.5 months (HR 0.80); 24-month OS 24.9% vs 10.4%.

Guideline Impact

NCCN category 1 first-line for advanced biliary tract cancer