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NCT Number: NCT06109779

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Biliary Tract Cancer Adenocarcinoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Gallbladder Neoplasms Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Camperdown, Australia

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About this study

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with curative intent. This study will be conducted in patients with BTC who are at risk of recurrence after resection with curative intent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rilvegostomig

Drug

Rilvegostomig IV (intravenous) Q3W

Placebo

Drug

Placebo IV (intravenous) Q3W

Capecitabine

Drug

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

Drug

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]

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Survival (OS) for Arm A vs. Arm B

    Time frame: up to 7 years

    Overall survival is defined as the time from randomization until the date of death due to any cause.

Other outcomes

  1. Patient-reported tolerability Arm A vs. Arm B.

    Time frame: Up to approximately 7 years.

    Patient-reported tolerability is a multi-component endpoint defined as the proportion of participants in each arm reporting side effect bother, clinically meaningful impact on physical functioning and descriptive data on treatment-related symptoms.

  2. Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.

    Time frame: Up to approximately 7years

    Progression-free survival following recurrence is defined as the time from randomization until the earliest progression event after the start of the first subsequent therapy or death.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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 (ARTEMIDE-Biliary01)

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Oct 31, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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