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Clinical Trials in the EU / 2025-523085-24-00
Authorised, recruiting Phase III

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).

2025-523085-24-00 · tracked via the Priya Life Science EU tracker
Sponsor
AstraZeneca AB
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
23/03/2026
Enrollment target
232
Sites
Germany, Poland, Italy, Belgium, France, Netherlands, Spain

Condition studied

Biliary Tract Cancer

Investigational medicinal product(s)

GEMCITABINEIMFINZI 50 mg/mL concentrate for solution for infusionINFLIXIMABCISPLATINMYCOPHENOLATE MOFETILRilvegostomig

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy

Endpoint detail

Progression Free Survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523085-24-00 on CTIS ↗ ← All trials in the EU