ARTEMIDE-Biliary02
Research type
Research Study
Full 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
IRAS ID
1013142
Contact name
Juliet Wou
Contact email
Eudract number
2025-523085-24
Clinicaltrials.gov Identifier
Research summary
This is a phase III study for adults with advanced biliary tract cancer (BTC).
The goal of the study is to see if an experimental medication called rilvegostomig plus chemotherapy helps people live longer than the current standard treatment, durvalumab with chemotherapy. The study will also look at how long before the cancer grows again, how much tumours shrink, how long benefits last, side effects, how the body handles the drug, whether the body forms antibodies to it, and quality of life and symptoms reported by patients. The study is also assessing whether a diagnostic test on the participant’s tumour sample, for a marker called PD-L1, can identify which patients benefit most from the treatment.
About 1,100 adults (age 18 or older) with advanced BTC will be enrolled from hospitals and research centers worldwide. The trial lasts until the cancer progresses, side effects become severe, or participants opt out.
What are the treatment groups?
Group 1: Rilvegostomig plus chemotherapy (gemcitabine and cisplatin) every 3 weeks for 8 cycles, then rilvegostomig every 3 weeks.
Group 2: Durvalumab plus chemotherapy every 3 weeks for 8 cycles, then durvalumab every 4 weeks. Treatment continues until the cancer grows, side effects are too strong, or you choose to stop.
Participant Involvement:
Eligibility: To join this trial, participants must be at least 18 years old and have advanced biliary tract cancer.
Procedures: Participants may have blood and urine tests, scans (CT/MRI), heart tests (ECG), physical exams, and possibly a tumour biopsy. Participants will also complete questionnaires about symptoms and daily life.
Potential Benefits and Risks:
A possible benefit of receiving rilvegostomig is improvement of a participant’s biliary tract cancer.
Possible risks include rashes, breathing problems, inflammation of vital organs, hormone changes, infusion reactions, and side effects from chemotherapy. The study team will monitor participants closely.REC name
London - Hampstead Research Ethics Committee
REC reference
26/LO/0050
Date of REC Opinion
26 Feb 2026
REC opinion
Further Information Favourable Opinion