A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506054-20-00

Acronym

D7025C00001

Enrollment

182

Registered

2024-05-03

Start date

2024-06-05

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma or muscle invasive gallbladder cancer GBC)

Brief summary

Recurrence free survival (RFS) for Arm A vs. Arm B

Detailed description

Overall Survival (OS) for Arm A vs. Arm B, Patient-reported tolerability Arm A vs. Arm B, Progression Free Survival (PFS) following recurrence Arm A vs. Arm B

Interventions

DRUGRilvegostomig

DRUGTEGAFUR

DRUGGLUCOSE

DRUGINFLIXIMAB

DRUGCAPECITABINE

DRUGCISPLATIN

DRUGMYCOPHENOLATE MOFETIL

DRUGGEMCITABINE

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence free survival (RFS) for Arm A vs. Arm B	—

Secondary

Measure	Time frame
Overall Survival (OS) for Arm A vs. Arm B, Patient-reported tolerability Arm A vs. Arm B, Progression Free Survival (PFS) following recurrence Arm A vs. Arm B	—

Countries

Belgium, Denmark, France, Germany, Italy, Norway, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026