A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) - AB02
Study identifier:D702NC00001
ClinicalTrials.gov identifier:NCT07221253
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
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)
Medical condition
biliary tract cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin
Sex
All
Estimated Enrollment
1100
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 04 Dec 2025
Estimated Primary Completion Date: 04 Jul 2029
Estimated Study Completion Date: 04 Jul 2029
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Control Arm Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) | Drug: Durvalumab Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W. Other Name: IMFINZI 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 Other Name: N/A |
| Experimental: Experimental Arm Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) | Drug: Rilvegostomig Rilvegostomig IV (intravenous) Q3W Other Name: AZD2936 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 Other Name: N/A |
