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

> **NCT03875235** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **AstraZeneca** · enrollment: 810 (actual)

## Conditions studied

- Biliary Tract Neoplasms

## Interventions

- **DRUG:** Durvalumab
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03875235
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-04-16
- **Primary completion:** 2021-08-11
- **Final completion:** 2027-05-16
- **Target enrollment:** 810 (ACTUAL)
- **Last updated:** 2026-03-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03875235

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03875235, "Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT03875235. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*