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)

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent. - ARTEMIDE-Bil01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230509

Enrollment

750

Registered

2023-12-13

Start date

2023-12-13

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Biliary Tract Cancer

Interventions

Drug: Rilvegostomig IV (intravenous) Drug: Placebo IV (intravenous) Drug: Gemcitabine/Cisplatin IV (Intravenous) Drug: S-1 [Tegafur/Oteracil/gimeracil] (Oral)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1) - Provision of a tumor sample collected at surgical resection. - Randomization within 12 weeks after resection with adequate healing and removal of drains. - Confirmed to be disease-free by imaging within 28 days prior to randomization. - Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion criteria

Exclusion criteria: - Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis. - Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors. - Any anti-cancer therapy for BTC prior to surgery - Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease - Current or prior use of immunosuppressive medication within 14 days before the first dose - Thromboembolic event within 3 months - Active HBV or HCV infection unless treated.

Design outcomes

Primary

Measure	Time frame
Recurrence free survival (RFS) for Arm A vs. Arm B [ Time Frame: Approximately 5 years ] Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.	—

Countries

Australia, Belgium, Brazil, Canada, China, Denmark, Finland, Germany, Hong Kong, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, UK, USA

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026