drugset / Trial / NCT07221253

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

NCT07221253

Phase 3 Recruiting 1100 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.

Timeline

Start
2025-12-04
Primary completion
2029-07-31
Completion
2029-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Rilvegostomig Other / unclassified Intravenous
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications