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

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: Recruiting
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: Rilvegostomig; Drug: Capecitabine; Drug: Gemcitabine/Cisplatin; Drug: S-1 [Tegafur/Oteracil/gimeracil]; Drug: Placebo

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 (Estimated): 750
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Not yet recruiting
    • Research Site
  • Murdoch, Australia, 6150
    • Recruiting
    • Research Site
  • Reservoir, Australia, 3021
    • Recruiting
    • Research Site
  • Westmead, Australia, 2145
    • Recruiting
    • Research Site
• Belgium
  • Brussels, Belgium, 1070
    • Not yet recruiting
    • Research Site
  • Bruxelles, Belgium, 1200
    • Not yet recruiting
    • Research Site
  • Edegem, Belgium, 2650
    • Not yet recruiting
    • Research Site
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • Research Site
• Brazil
  • Natal, Brazil, 59075-740
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 90035-000
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Not yet recruiting
    • Research Site
  • Santa Maria, Brazil, 97015-450
    • Recruiting
    • Research Site
  • Santo Andre, Brazil, 09060-870
    • Recruiting
    • Research Site
  • Sao Paulo, Brazil, 01246-000
    • Not yet recruiting
    • Research Site
  • Sao Paulo, Brazil, 01327-001
    • Not yet recruiting
    • Research Site
  • Vitória, Brazil, 29043-260
    • Recruiting
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Not yet recruiting
    • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Not yet recruiting
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Not yet recruiting
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • Research Site
  • Ontario
    • Kingston, Ontario, Canada, K7L 5P9
      • Recruiting
      • Research Site
    • London, Ontario, Canada, N6C 2R5
      • Not yet recruiting
      • Research Site
    • Mississauga, Ontario, Canada, L5M 2N1
      • Not yet recruiting
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Not yet recruiting
      • Research Site
• China
  • Shanghai, China, 200032
    • Not yet recruiting
    • Research Site
• Denmark
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Research Site
• France
  • Marseille, France, 13273
    • Not yet recruiting
    • Research Site
  • Paris Cedex 5, France, 75248
    • Not yet recruiting
    • Research Site
  • Pessac, France, 33604
    • Not yet recruiting
    • Research Site
  • Rennes, France, 35000
    • Not yet recruiting
    • Research Site
  • Strasbourg, France, 67033
    • Not yet recruiting
    • Research Site
  • Toulouse Cedex 9, France, 31059
    • Not yet recruiting
    • Research Site
  • Villejuif, France, 94800
    • Not yet recruiting
    • Research Site
• Germany
  • Berlin, Germany, 13353
    • Not yet recruiting
    • Research Site
  • Bonn, Germany, 53127
    • Not yet recruiting
    • Research Site
  • Dortmund, Germany, 44137
    • Not yet recruiting
    • Research Site
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Research Site
  • Erlangen, Germany, 91054
    • Not yet recruiting
    • Research Site
  • Essen, Germany, 45122
    • Not yet recruiting
    • Research Site
  • Esslingen, Germany, 73730
    • Not yet recruiting
    • Research Site
  • Frankfurt, Germany, 60488
    • Not yet recruiting
    • Research Site
  • Hamburg, Germany, 22763
    • Not yet recruiting
    • Research Site
  • Heidelberg, Germany, 69120
    • Not yet recruiting
    • Research Site
  • Köln, Germany, 50937
    • Not yet recruiting
    • Research Site
  • Leipzig, Germany, 4103
    • Not yet recruiting
    • Research Site
  • Luebeck, Germany, 23538
    • Not yet recruiting
    • Research Site
  • München, Germany, 81377
    • Not yet recruiting
    • Research Site
  • München, Germany, 81737
    • Not yet recruiting
    • Research Site
  • Münster, Germany, 48149
    • Not yet recruiting
    • Research Site
  • Stuttgart, Germany, 70174
    • Not yet recruiting
    • Research Site
  • Ulm, Germany, 89081
    • Not yet recruiting
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Research Site
  • Hong Kong, Hong Kong, 00000
    • Not yet recruiting
    • Research Site
  • Hong Kong, Hong Kong, 0000
    • Not yet recruiting
    • Research Site
  • Shatin, Hong Kong, 00000
    • Not yet recruiting
    • Research Site
• India
  • Delhi, India, 110088
    • Not yet recruiting
    • Research Site
  • Kolkata, India, 700094
    • Not yet recruiting
    • Research Site
  • Mumbai, India, 400012
    • Not yet recruiting
    • Research Site
  • Mysuru, India, 570017
    • Not yet recruiting
    • Research Site
  • New Delhi, India, 110085
    • Not yet recruiting
    • Research Site
  • New Delhi, India, 110076
    • Not yet recruiting
    • Research Site
  • Vadodara, India, 391760
    • Suspended
    • Research Site
  • Varanasi, India, 221005
    • Not yet recruiting
    • Research Site
• Italy
  • Firenze, Italy, 50134
    • Not yet recruiting
    • Research Site
  • Milano, Italy, 20133
    • Not yet recruiting
    • Research Site
  • Milano, Italy, 20162
    • Not yet recruiting
    • Research Site
  • Padova, Italy, 35128
    • Not yet recruiting
    • Research Site
  • Pisa, Italy, 56126
    • Not yet recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Not yet recruiting
    • Research Site
  • Tricase, Lecce, Italy, 73039
    • Not yet recruiting
    • Research Site
• Japan
  • Chuo-ku, Japan, 104-0045
    • Not yet recruiting
    • Research Site
  • Kashiwa, Japan, 227-8577
    • Recruiting
    • Research Site
  • Kitaadachi-gun, Japan, 362-0806
    • Recruiting
    • Research Site
  • Nagoya-shi, Japan, 464-8681
    • Not yet recruiting
    • Research Site
  • Osaka-shi, Japan, 541-8567
    • Recruiting
    • Research Site
  • Suita-shi, Japan, 565-0871
    • Recruiting
    • Research Site
  • Yokohama-shi, Japan, 241-8515
    • Recruiting
    • Research Site
• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 13620
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Research Site
• Norway
  • Oslo, Norway, 450
    • Not yet recruiting
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-796
    • Not yet recruiting
    • Research Site
  • Katowice, Poland, 40-514
    • Not yet recruiting
    • Research Site
  • Kraków, Poland, 31-501
    • Not yet recruiting
    • Research Site
  • Lublin, Poland, 20-081
    • Not yet recruiting
    • Research Site
  • Przemysl, Poland, 37-700
    • Not yet recruiting
    • Research Site
  • Tomaszów Mazowiecki, Poland, 97-200
    • Not yet recruiting
    • Research Site
  • Warszawa, Poland, 02-034
    • Not yet recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Research Site
  • Barcelona, Spain, 8035
    • Not yet recruiting
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08908
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Research Site
  • Málaga, Spain, 29011
    • Not yet recruiting
    • Research Site
  • Pamplona, Spain, 31005
    • Not yet recruiting
    • Research Site
  • Santander, Spain, 39008
    • Not yet recruiting
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 82445
    • Not yet recruiting
    • Research Site
  • Kaohsiung, Taiwan, 83301
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40705
    • Not yet recruiting
    • Research Site
  • Taichung, Taiwan, 40447
    • Not yet recruiting
    • Research Site
  • Tainan City, Taiwan, 70403
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10002
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 112
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
• Thailand
  • Hat Yai, Thailand, 90110
    • Not yet recruiting
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Not yet recruiting
    • Research Site
  • Muang, Thailand, 50200
    • Recruiting
    • Research Site
  • Muang, Thailand, 34000
    • Not yet recruiting
    • Research Site
  • Naimuang, Thailand, 30000
    • Not yet recruiting
    • Research Site
  • Sisaket, Thailand, 33000
    • Not yet recruiting
    • Research Site
• Turkey
  • Ankara, Turkey, 06620
    • Not yet recruiting
    • Research Site
  • Ankara, Turkey, 06230
    • Not yet recruiting
    • Research Site
  • Ankara, Turkey, 06100
    • Not yet recruiting
    • Research Site
  • Antalya, Turkey, 07100
    • Not yet recruiting
    • Research Site
  • Erzurum, Turkey, 25240
    • Not yet recruiting
    • Research Site
  • Fatih-Istanbul, Turkey, 34098
    • Not yet recruiting
    • Research Site
  • Istanbul, Turkey, 34722
    • Not yet recruiting
    • Research Site
  • Samsun, Turkey, 55270
    • Not yet recruiting
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Not yet recruiting
    • Research Site
  • Edgbaston, United Kingdom, B15 2WB
    • Not yet recruiting
    • Research Site
  • Glasgow, Scotland, United Kingdom, G12 0YN
    • Not yet recruiting
    • Research Site
  • London, United Kingdom, NW3 2QG
    • Not yet recruiting
    • Research Site
  • London, United Kingdom, W12 0HS
    • Withdrawn
    • Research Site
  • London, United Kingdom, WC1E 6BT
    • Not yet recruiting
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Not yet recruiting
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Not yet recruiting
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Not yet recruiting
      • Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Not yet recruiting
      • Research Site
  • California
    • Los Angeles, California, United States, 90089
      • Not yet recruiting
      • Research Site
    • Orange, California, United States, 92868
      • Not yet recruiting
      • Research Site
    • Stanford, California, United States, 94305
      • Not yet recruiting
      • Research Site
    • West Hollywood, California, United States, 90048
      • Not yet recruiting
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Not yet recruiting
      • Research Site
  • Florida
    • Gainesville, Florida, United States, 32611
      • Withdrawn
      • Research Site
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Not yet recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Not yet recruiting
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Not yet recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Research Site
  • New York
    • Commack, New York, United States, 11725
      • Not yet recruiting
      • Research Site
    • Mineola, New York, United States, 11501
      • Not yet recruiting
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Not yet recruiting
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19144
      • Not yet recruiting
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Not yet recruiting
      • Research Site
    • Tyler, Texas, United States, 75702
      • Not yet recruiting
      • Research Site
  • Washington
    • Vancouver, Washington, United States, 98684
      • Not yet recruiting
      • Research Site

Participation Criteria

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) 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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.	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.	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

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): September 30, 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): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Capecitabine; Immunotherapy; S-1; Cholangiocarcinoma; Gall bladder cancer; Intrahepatic Cholangiocarcinoma; Bile duct cancer; Perihilar Cholangiocarcinoma; Rilvegostomig; Adenocarcinoma of the biliary tract; Biliary tract Cancer; Distal Cholangiocarcinoma; Klatskin Tumors; Gemcitabine/cisplatin
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Tegafur; Gemcitabine
• 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