Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
810actual
Sites
126
Countries
Argentina, Bulgaria, Chile +14
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-04-16 | actual | When the study began enrolling |
| Primary completion | 2021-08-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-05-16 | estimated | The whole study's end, after follow-up |
| First posted | 2019-03-14 | actual | When this record first appeared on the registry |
| Results posted | 2023-04-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Biliary Tract Neoplasms
Interventions
- Drug: Durvalumab
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFOverall Survival (OS)
measured From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)
Overall Survival (OS) Rate at 18 Months
measured From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
Overall Survival (OS) Rate at 24 Months
measured From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-03-01 · 2.2 MB · Prot_003.pdf
Statistical Analysis Planposted 2021-10-12 · 1.4 MB · SAP_004.pdf
Publications
- PMID 42424063 — linked by the registry
- PMID 40622010 — linked by the registry
- PMID 40381735 — linked by the registry
- PMID 38823398 — linked by the registry
- PMID 38697156 — linked by the registry
- PMID 38661512 — linked by the registry
- PMID 38319896 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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