ARTEMIDE-Biliary01
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo-Controlled,Multicenter, Global Study of Rilvegostomig in Combination WithChemotherapy as Adjuvant Treatment After Resection of BiliaryTract Cancer With Curative Intent (ARTEMIDE-Biliary01)
IRAS ID
1008884
Contact name
Ghada Chaabani
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Trial Background: Surgery offers a chance of cure to some patients with biliary tract cancer (BTC).
This is usually followed by chemotherapy to reduce the risk of BTC coming back. This trial is testing, if the study drug rilvegostomig together with chemotherapy can further reduce the risk of BTC coming back.
Rilvegostomig functions by helping the immune system to find and remove tumor cells by blocking proteins called PD-1 and TIGIT. Tumor cells normally use these proteins to avoid being killed by immune cells.
Primary Question: Does rilvegostomig with chemotherapy help participants live longer without their cancer coming back after surgery compared with a placebo with chemotherapy?
Trial Population: Participants will be 18 years of age or older whose BTC has been removed by surgery within 12 weeks prior to joining this trial. People whose cancer has spread to other parts of the body or that cannot be completely removed by surgery cannot participate in this trial.
Study Procedures: This study will enroll approximately 750 patients globally.
Participants will receive standard chemotherapy (selected by the study doctor) for up to 6 months and rilvegostomig or placebo for up to 1 year. After that, participants will visit the study site every few months to check if their cancer has come back and how they are doing. Overall, participants will be in the trial for up to approximately 6 years and 9 months.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0007
Date of REC Opinion
7 Feb 2024
REC opinion
Further Information Favourable Opinion