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Combining rilvegostomig with chemotherapy for biliary tract cancer after surgery

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)

PHASE3 · AstraZeneca · NCT06109779

This study is testing if adding a new drug called rilvegostomig to standard chemotherapy can help prevent cancer from coming back in patients with biliary tract cancer after surgery.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionschemotherapy
Locations211 sites (Birmingham, Alabama and 210 other locations)
Trial IDNCT06109779 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the effectiveness and safety of rilvegostomig in conjunction with standard chemotherapy options for patients with biliary tract cancer (BTC) who have undergone surgical resection. Participants will be randomly assigned to receive either rilvegostomig or a placebo alongside their chosen chemotherapy regimen, which may include capecitabine, S-1, or gemcitabine/cisplatin. The study aims to determine if this combination can reduce the risk of cancer recurrence in patients who are disease-free after surgery.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed adenocarcinoma of the biliary tract who have undergone complete surgical resection and are disease-free.

Not a fit: Patients with locally advanced, unresectable, or metastatic biliary tract cancer at diagnosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with biliary tract cancer by reducing recurrence rates after surgery.

How similar studies have performed: Previous studies have shown promising results with similar approaches in treating biliary tract cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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:

* 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.

Where this trial is running

Birmingham, Alabama and 210 other locations

+161 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Biliary Tract Cancer, Adenocarcinoma of the biliary tract, Biliary tract Cancer, Gall bladder cancer, Intrahepatic Cholangiocarcinoma, Distal Cholangiocarcinoma, Perihilar Cholangiocarcinoma, Klatskin Tumors

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.