Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (ARTEMIDE-Bil01)

March 3, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

757

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Research Site
      • Clayton, Australia, 3168
        • Research Site
      • Murdoch, Australia, 6150
        • Research Site
      • Westmead, Australia, 2145
        • Research Site
  • Belgium
      • Brussels, Belgium, 1200
        • Research Site
      • Brussels, Belgium, 1070
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Brazil
      • Natal, Brazil, 59075-740
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90035-000
        • Research Site
      • Santa Maria, Brazil, 97015-450
        • Research Site
      • Santo André, Brazil, 09060-870
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
      • São Paulo, Brazil, 01327-001
        • Research Site
      • Vitória, Brazil, 29043-260
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, VSZ 4E6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
      • London, Ontario, Canada, N6C 2R5
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Québec, Quebec, Canada, G1J 1Z4
        • Research Site
  • China
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, CN-100730
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Chengdu, China, 610000
        • Research Site
      • Chengdu, China, 610072
        • Research Site
      • Deyang, China, 618000
        • Research Site
      • Fuzhou, China, 350005
        • Research Site
      • Guangzhou, China, 510515
        • Research Site
      • Guiyang, China, 550044
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Hefei, China, 230001
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Kunming, China, 650101
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Lishui, China, 323000
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 2100008
        • Research Site
      • Nanjing, China, 210029
        • Research Site
      • Nanning, China, 530021
        • Research Site
      • Shandong, China
        • Research Site
      • Shanghai, China, 201114
        • Research Site
      • Shenyang, China, 110004
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Wuhan, China, 430079
        • Research Site
      • Wuhan, China, 430071
        • Research Site
      • Xi'an, China, 710061
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
  • Denmark
      • Herlev, Denmark, 2730
        • Research Site
  • France
      • Marseille, France, 13273
        • Research Site
      • Montpellier, France, 34295
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Rennes, France, 35000
        • Research Site
      • Strasbourg, France, 67033
        • Research Site
      • Toulouse, France, 31059
        • Research Site
      • Villejuif, France, 94800
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Bonn, Germany, 53127
        • Research Site
      • Dortmund, Germany, 44137
        • Research Site
      • Dresden, Germany, 01370
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Esslingen A. N., Germany, 73730
        • Research Site
      • Frankfurt, Germany, 60488
        • Research Site
      • Hamburg, Germany, 22763
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Leipzig, Germany, 4103
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
      • München, Germany, 81377
        • Research Site
      • München, Germany, 81737
        • Research Site
      • Münster, Germany, 48129
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Research Site
      • Shatin, Hong Kong, 00000
        • Research Site
  • India
      • Delhi, India, 110088
        • Research Site
      • Kolkata, India, 700094
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • Mysuru, India, 570017
        • Research Site
      • New Delhi, India, 110085
        • Research Site
      • New Delhi, India, 110076
        • Research Site
      • Varanasi, India, 221005
        • Research Site
  • Italy
      • Florence, Italy, 50134
        • Research Site
      • Milan, Italy, 20162
        • Research Site
      • Milan, Italy, 20133
        • Research Site
      • Padua, Italy, 35128
        • Research Site
      • Pisa, Italy, 56126
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
      • Tricase, Lecce, Italy, 73039
        • Research Site
  • Japan
      • Hiroshima, Japan, 734-8551
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Mitaka-shi, Japan, 181-8611
        • Research Site
      • Nagoya, Japan, 466-8560
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Toyama, Japan, 930-0194
        • Research Site
      • Ube, Japan, 755-8505
        • Research Site
      • Wakayama, Japan, 641-8510
        • Research Site
      • Yokohama, Japan, 236-0004
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
  • Norway
      • Oslo, Norway, 0379
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Research Site
      • Krakow, Poland, 31-501
        • Research Site
      • Lublin, Poland, 20-080
        • Research Site
      • Przemyśl, Poland, 37-700
        • Research Site
      • Warsaw, Poland, 02-034
        • Research Site
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 06591
        • Research Site
  • Spain
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 8035
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08908
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Málaga, Spain, 29011
        • Research Site
      • Pamplona, Spain, 31005
        • Research Site
      • Santander, Spain, 39008
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taoyuan District, Taiwan, 333
        • Research Site
  • Thailand
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Muang, Thailand, 34000
        • Research Site
      • Naimuang, Thailand, 30000
        • Research Site
      • Si Sa Ket, Thailand, 33000
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Research Site
      • Ankara, Turkey (Türkiye), 06230
        • Research Site
      • Antalya, Turkey (Türkiye), 07100
        • Research Site
      • Erzurum, Turkey (Türkiye), 25240
        • Research Site
      • Fatih-Istanbul, Turkey (Türkiye), 34098
        • Research Site
      • Samsun, Turkey (Türkiye), 55139
        • Research Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • Edgbaston, United Kingdom, B15 2WB
        • Research Site
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
    • California
      • Los Angeles, California, United States, 90089
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Littleton, Colorado, United States, 80129
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Research Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Research Site
    • New York
      • Commack, New York, United States, 11725
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Drug: Rilvegostomig
Rilvegostomig IV (intravenous) Q3W
Drug: Capecitabine
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
Drug: 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
Drug: 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
Placebo Comparator: Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Drug: Capecitabine
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
Drug: 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
Drug: 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
Drug: Placebo
Placebo IV (intravenous) Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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.
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 7 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 7 years.
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.
Up to approximately 7years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

January 2, 2029

Study Completion (Estimated)

May 3, 2030

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7025C00001
  • 2023-506054-20-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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