Trial Profile

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

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 28 May 2026

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At a glance

Drugs Durvalumab (Primary) ; Cisplatin; Gemcitabine; Infliximab; Mycophenolate mofetil
Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
Focus Registrational; Therapeutic Use
Acronyms TOPAZ-1
Sponsors AstraZeneca; AstraZeneca AB; AstraZeneca KK

27 Feb 2026 Planned End Date changed from 31 Dec 2025 to 16 May 2027.
22 Jun 2025 Planned End Date changed from 31 Mar 2025 to 31 Dec 2025.
17 Jan 2025 Results of the population pharmacokinetics (PopPK) of durvalumab, and exposure-response for efficacy and safety (ERES) of TOPAZ-1 published in the Cancer Chemotherapy and Pharmacology.

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