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Active, not recruiting Phase 3 Interventional Results available

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

ClinicalTrials.gov ID: NCT03875235

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.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 4:04 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).

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

Interventions

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 16, 2019 (Actual)
Primary completion
Aug 11, 2021 (Actual)
Completion
May 16, 2027 (Estimated)
Last update posted
Aug 26, 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 Aug 26, 2026 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03875235 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →