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Closed (no longer recruiting)Last updated: 6 October 2025

ARTEMIDE-Biliary01: This study is assessing immunotherapy compared to placebo in combination with chemotherapy in people with biliary tract cancer who have had prior surgeryA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

ARTEMIDE-Biliary01

Clinical summary

Summary

Eligible participants will be randomly assigned to one of two treatment arms.

In Arm A (Experimental) participants will receive Rilvegostomig immunotherapy plus the Investigator's choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S01).

Rilvegostomig will be administered intravenously every three weeks.

If chosen, Capecitabine will be administered orally (1250mg/m2) twice daily for 2 weeks on/1 week off in 21-day cycles or per local practice, Gemcitabine/Cisplatin will be given intravenously (1000mg/m2 plus cisplatin 25mg/m2) on Day 1 and Day 8 of each 21-day cycle, and S-1 [Tegafur/Oteracil/gimeracil] will be given orally twice daily for 4 weeks on and 2 weeks off in 42-day cycles.

In Arm B (Placebo Comparator), participants will receive a placebo IV infusion + Investigator's choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1).

Placebo IV will be given every three weeks. Chemotherapy will be administered as described above in Arm A.

Conditions

This trial is treating patients with biliary tract cancer who have had a complete resection (surgical removal of their cancer)

Eligibility

Inclusion

  • Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) 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

  • 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.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

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

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