Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Public ClinicalTrials.gov record NCT03875235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03875235
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AstraZeneca
- Industry
- Enrollment
- 810 participants
Conditions and interventions
Conditions
Interventions
- Durvalumab Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 15, 2019
- Primary completion
- Aug 10, 2021
- Completion
- May 15, 2027
- Last update posted
- Mar 18, 2026
2019 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Los Angeles | California | 90027 | — |
| Research Site | Orange | California | 92868 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Fort Myers | Florida | 33905 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Westwood | Kansas | 66205 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Burlington | Massachusetts | 01805 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | Chapel Hill | North Carolina | 27514 | — |
| Research Site | Portland | Oregon | 97213 | — |
| Research Site | Philadelphia | Pennsylvania | 19111 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 111 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03875235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2026 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03875235 live on ClinicalTrials.gov.