TOPAZ-1: NCT03875235: Phase 3: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer
- CTD
- Dec 15, 2022
- 2 min read
Updated: Feb 9
First Posted | 2019-03-14 |
Trial status | Active, not recruiting |
Sponsor | AstraZeneca |
Abstract Presentation | A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1. 2022 ASCO Gastrointestinal Cancers Symposium Updated overall survival (OS) from the phase III TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC) September 2022
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Peer-reviewed journal publication | Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer August,2022 Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial May 2024 Durvalumab plus chemotherapy in advanced biliary tract cancer: 3-year overall survival update from the phase III TOPAZ-1 study 2025 Nov |
Press Release | Imfinzi plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up 12 September 2022 |
FDA | FDA approves durvalumab for locally advanced or metastatic biliary tract cancer September 2, 2022 |
NCCN |
TOPAZ-1: NCT03875235: Phase 3: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer
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 |
Intervention / Treatment: |
Drug: Durvalumab Drug: Placebo |
Other Study ID Numbers: |
D933AC00001 2023-507405-34-00 ( Registry Identifier ) (REGISTRY: CTIS (EU)) 2018-004688-30 ( EudraCT Number ) |
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT03875235 |