Trials / Recruiting
RecruitingNCT07221253
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,100 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rilvegostomig | Rilvegostomig IV (intravenous) Q3W |
| DRUG | Durvalumab | Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W. |
| DRUG | Gemcitabine/Cisplatin | Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle |
Timeline
- Start date
- 2025-12-04
- Primary completion
- 2029-07-04
- Completion
- 2029-07-04
- First posted
- 2025-10-27
- Last updated
- 2026-03-17
Locations
168 sites across 19 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, India, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07221253. Inclusion in this directory is not an endorsement.