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Clinical Trials in South Korea / NCT06109779
Active, not recruiting Phase 3

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

NCT06109779 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-12-04
Last updated
2026-07-10

Condition(s) studied

Biliary Tract Cancer

Investigational drug(s) / intervention(s)

Rilvegostomig →PlaceboCapecitabine →Gemcitabine/Cisplatin →S-1 [Tegafur/Oteracil/gimeracil] →

Rilvegostomig: Rilvegostomig IV (intravenous) Q3W

Placebo: Placebo IV (intravenous) Q3W

Capecitabine: Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice

Gemcitabine/Cisplatin: Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

S-1 [Tegafur/Oteracil/gimeracil]: S-1 \[Tegafur/Oteracil/gimeracil\] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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: * 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.

Primary outcome measure(s)

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

Trial sites (177)

FacilityCityRegionStatus
Research Site Birmingham Alabama
Research Site Phoenix Arizona
Research Site Los Angeles California
Research Site Orange California
Research Site Stanford California
Research Site Aurora Colorado
Research Site Littleton Colorado
Research Site Washington D.C. District of Columbia
Research Site Jacksonville Florida
Research Site Atlanta Georgia
Research Site Chicago Illinois
Research Site Iowa City Iowa
Research Site Kansas City Kansas
Research Site Lexington Kentucky
Research Site New Orleans Louisiana
Research Site Grand Rapids Michigan
Research Site Rochester Minnesota
Research Site St Louis Missouri
Research Site Commack New York
Research Site Mineola New York
Research Site Philadelphia Pennsylvania
Research Site Dallas Texas
Research Site Camperdown Australia
Research Site Clayton Australia
Research Site Murdoch Australia
Research Site Westmead Australia
Research Site Brussels Belgium
Research Site Brussels Belgium
Research Site Edegem Belgium
Research Site Leuven Belgium
Research Site Natal Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Santa Maria Brazil
Research Site Santo André Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Vitória Brazil
Research Site Vancouver British Columbia
Research Site Halifax Nova Scotia

+ 137 more sites — see the full list on the official registry below.

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A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) Recruiting
Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC Recruiting
Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab Recruiting
Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer Recruiting
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer Recruiting
Official registry record

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

View NCT06109779 on ClinicalTrials.gov ↗ ← All trials in South Korea