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 (TOPAZ-1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507405-34-00

Acronym

D933AC00001

Enrollment

125

Registered

2024-06-05

Start date

2019-08-07

Completion date

Unknown

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line patients with advanced biliary tract cancers (BTC)

Brief summary

Overall survival

Detailed description

Progression-free survival (PFS), ORR (Objective response rate) , and Duration of response (DoR) according to RECIST 1.1using Investigator assessments, ORR and DoR according to RECIST 1.1 using BICR assessments, EORTC QLQ-C30: Global health status/QoL and impacts (eg, physical function); multi-term symptoms (eg, fatigue); and single items (eg, appetite loss, insomnia). EORTC QLQ-BIL21: Single-item symptoms (eg, abdominal pain [item 42], pruritus [item 36], jaundice [item 35]), Association of PD-L1 expression level with PFS, ORR, DoR, and DCR (Disease control rate) according to RECIST 1.1 using Investigator assessments and OS (Overall survival), Serum concentration of durvalumab (peak and trough concentrations), Presence of ADAs for durvalumab (confirmatory results: positive or negative)

Interventions

DRUGCISPLATIN

DRUGINFLIXIMAB

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGGEMCITABINE

DRUGMYCOPHENOLATE MOFETIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression-free survival (PFS), ORR (Objective response rate) , and Duration of response (DoR) according to RECIST 1.1using Investigator assessments, ORR and DoR according to RECIST 1.1 using BICR assessments, EORTC QLQ-C30: Global health status/QoL and impacts (eg, physical function); multi-term symptoms (eg, fatigue); and single items (eg, appetite loss, insomnia). EORTC QLQ-BIL21: Single-item symptoms (eg, abdominal pain [item 42], pruritus [item 36], jaundice [item 35]), Association of PD-L1 expression level with PFS, ORR, DoR, and DCR (Disease control rate) according to RECIST 1.1 using Investigator assessments and OS (Overall survival), Serum concentration of durvalumab (peak and trough concentrations), Presence of ADAs for durvalumab (confirmatory results: positive or negative)	—

Measure

Time frame

—

Countries

Bulgaria, France, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026