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

Last updated: March 6, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Biliary Tract Cancer

Digestive System Neoplasms

Gall Bladder Cancer

Treatment

Placebo

Gemcitabine/Cisplatin

S-1 [Tegafur/Oteracil/gimeracil]

Clinical Study ID

NCT06109779
D7025C00001
2023-506054-20-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic orextrahepatic 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 ofdrains.

  • Confirmed to be disease-free by imaging within 28 days prior to randomization.

  • Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion

Exclusion Criteria:

  • Participants with locally-advanced, unresectable, or metastatic disease at initialdiagnosis.

  • Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrineneoplasms and nonepithelial tumors.

  • Any anti-cancer therapy for BTC prior to surgery

  • Active or prior documented autoimmune or inflammatory disorders or any severe oruncontrolled systemic disease

  • Current or prior use of immunosuppressive medication within 14 days before the firstdose

  • Thromboembolic event within 3 months

  • Active HBV or HCV infection unless treated.

Study Design

Total Participants: 750
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 04, 2023
Estimated Completion Date:
September 30, 2030

Study 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.

Connect with a study center

  • Research Site

    Camperdown, 2050
    Australia

    Active - Recruiting

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    Murdoch, 6150
    Australia

    Active - Recruiting

  • Research Site

    Reservoir, 3021
    Australia

    Site Not Available

  • Research Site

    Westmead, 2145
    Australia

    Active - Recruiting

  • Research Site

    Brussels, 1070
    Belgium

    Active - Recruiting

  • Research Site

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Research Site

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Research Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Research Site

    Natal, 59075-740
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035-000
    Brazil

    Active - Recruiting

  • Research Site

    Santa Maria, 97015-450
    Brazil

    Active - Recruiting

  • Research Site

    Santo Andre, 09060-870
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Research Site

    Vitória, 29043-260
    Brazil

    Active - Recruiting

  • Research Site

    Vancouver, British Columbia VSZ 4E6
    Canada

    Active - Recruiting

  • Research Site

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Research Site

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Research Site

    Brampton, Ontario L6R 3J7
    Canada

    Site Not Available

  • Research Site

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Research Site

    London, Ontario N6C 2R5
    Canada

    Active - Recruiting

  • Research Site

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Research Site

    Quebec, G1J 1Z4
    Canada

    Active - Recruiting

  • Research Site

    Beijing, 100142
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

    Site Not Available

  • Research Site

    Changsha, 410013
    China

    Site Not Available

  • Research Site

    Chengdu, 610072
    China

    Site Not Available

  • Research Site

    Deyang, 618000
    China

    Site Not Available

  • Research Site

    Fuzhou, 350005
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Guiyang, 550044
    China

    Site Not Available

  • Research Site

    Hangzhou, 310009
    China

    Site Not Available

  • Research Site

    Harbin, 150081
    China

    Site Not Available

  • Research Site

    Hefei, 230601
    China

    Site Not Available

  • Research Site

    Kunming, 650101
    China

    Site Not Available

  • Research Site

    Lanzhou, 730000
    China

    Site Not Available

  • Research Site

    Lishui, 323000
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330006
    China

    Site Not Available

  • Research Site

    Nanjing, 210029
    China

    Site Not Available

  • Research Site

    Nanning, 530021
    China

    Site Not Available

  • Research Site

    Shandong,
    China

    Active - Recruiting

  • Research Site

    Shanghai, 201114
    China

    Active - Recruiting

  • Research Site

    Shenyang, 110004
    China

    Site Not Available

  • Research Site

    Tianjin Shi, 300060
    China

    Site Not Available

  • Research Site

    Wuhan, 430079
    China

    Site Not Available

  • Research Site

    Xi'an, 710061
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

    Site Not Available

  • Research Site

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Research Site

    MONTPELLIER Cedex 5, 34295
    France

    Site Not Available

  • Research Site

    Marseille, 13273
    France

    Site Not Available

  • Research Site

    Montpellier, 34295
    France

    Site Not Available

  • Research Site

    Paris Cedex 5, 75248
    France

    Site Not Available

  • Research Site

    Pessac, 33604
    France

    Active - Recruiting

  • Research Site

    Rennes, 35000
    France

    Active - Recruiting

  • Research Site

    Strasbourg, 67033
    France

    Site Not Available

  • Research Site

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Research Site

    Villejuif, 94800
    France

    Active - Recruiting

  • Research Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Research Site

    Bonn, 53127
    Germany

    Active - Recruiting

  • Research Site

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Research Site

    Dresden, 01370
    Germany

    Site Not Available

  • Research Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Research Site

    Essen, 45122
    Germany

    Site Not Available

  • Research Site

    Esslingen, 73730
    Germany

    Site Not Available

  • Research Site

    Esslingen A. N., 73730
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt, 60488
    Germany

    Active - Recruiting

  • Research Site

    Hamburg, 22763
    Germany

    Active - Recruiting

  • Research Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Research Site

    Köln, 50937
    Germany

    Site Not Available

  • Research Site

    Leipzig, 4103
    Germany

    Site Not Available

  • Research Site

    Luebeck, 23538
    Germany

    Site Not Available

  • Research Site

    Lübeck, 23538
    Germany

    Site Not Available

  • Research Site

    München, 81737
    Germany

    Active - Recruiting

  • Research Site

    Münster, 48129
    Germany

    Site Not Available

  • Research Site

    Stuttgart, 70174
    Germany

    Site Not Available

  • Research Site

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Research Site

    Ulm, 89081
    Germany

    Active - Recruiting

  • Research Site

    Hong Kong, 999077
    Hong Kong

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  • Research Site

    Shatin, 00000
    Hong Kong

    Active - Recruiting

  • Research Site

    Delhi, 110088
    India

    Active - Recruiting

  • Research Site

    Kolkata, 700094
    India

    Active - Recruiting

  • Research Site

    Mumbai, 400012
    India

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  • Research Site

    Mysuru, 570017
    India

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  • Research Site

    New Delhi, 110076
    India

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  • Research Site

    Vadodara, 391760
    India

    Suspended

  • Research Site

    Varanasi, 221005
    India

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  • Research Site

    Firenze, 50134
    Italy

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  • Research Site

    Milano, 20133
    Italy

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  • Research Site

    Padova, 35128
    Italy

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  • Research Site

    Pisa, 56126
    Italy

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  • Research Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Research Site

    Tricase, Lecce, 73039
    Italy

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Research Site

    Hiroshima-shi, 734-8551
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 227-8577
    Japan

    Active - Recruiting

  • Research Site

    Kitaadachi-gun, 362-0806
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Mitaka-shi, 181-8611
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 464-8681
    Japan

    Active - Recruiting

  • Research Site

    Osaka-shi, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Sendai-shi, 980-8574
    Japan

    Active - Recruiting

  • Research Site

    Suita-shi, 565-0871
    Japan

    Active - Recruiting

  • Research Site

    Toyama-shi, 930-0194
    Japan

    Active - Recruiting

  • Research Site

    Ube, 755-8505
    Japan

    Active - Recruiting

  • Research Site

    Wakayama-shi, 641-8510
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Seongnam-si, 13620
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Oslo, 450
    Norway

    Active - Recruiting

  • Research Site

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Research Site

    Katowice, 40-514
    Poland

    Active - Recruiting

  • Research Site

    Koszalin, 75-581
    Poland

    Active - Recruiting

  • Research Site

    Kraków, 31-501
    Poland

    Active - Recruiting

  • Research Site

    Lublin, 20-080
    Poland

    Active - Recruiting

  • Research Site

    Przemysl, 37-700
    Poland

    Active - Recruiting

  • Research Site

    Tomaszów Mazowiecki, 97-200
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-034
    Poland

    Active - Recruiting

  • Research Site

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Research Site

    L'Hospitalet de Llobregat, 08908
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28007
    Spain

    Active - Recruiting

  • Research Site

    Málaga, 29011
    Spain

    Active - Recruiting

  • Research Site

    Pamplona, 31005
    Spain

    Active - Recruiting

  • Research Site

    Santander, 39008
    Spain

    Active - Recruiting

  • Research Site

    Kaohsiung, 82445
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Research Site

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Research Site

    Muang, 34000
    Thailand

    Active - Recruiting

  • Research Site

    Naimuang, 30000
    Thailand

    Active - Recruiting

  • Research Site

    Sisaket, 33000
    Thailand

    Active - Recruiting

  • Research Site

    Ankara, 06620
    Turkey

    Site Not Available

  • Research Site

    Antalya, 07100
    Turkey

    Site Not Available

  • Research Site

    Erzurum, 25240
    Turkey

    Site Not Available

  • Research Site

    Fatih-Istanbul, 34098
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34722
    Turkey

    Site Not Available

  • Research Site

    Samsun, 55139
    Turkey

    Site Not Available

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Edgbaston, B15 2WB
    United Kingdom

    Active - Recruiting

  • Research Site

    Glasgow, Scotland, G12 0YN
    United Kingdom

    Active - Recruiting

  • Research Site

    London, WC1E 6BT
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Research Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Research Site

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Research Site

    Duarte, California 91010
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • Research Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Research Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Research Site

    Stanford, California 94305
    United States

    Active - Recruiting

  • Research Site

    West Hollywood, California 90048
    United States

    Site Not Available

  • Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Research Site

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • Research Site

    Littleton, Colorado 80129
    United States

    Active - Recruiting

  • Research Site

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Research Site

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Research Site

    Gainesville, Florida 32611
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Research Site

    Lexington, Kentucky 40506
    United States

    Active - Recruiting

  • Research Site

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site

    Commack, New York 11725
    United States

    Active - Recruiting

  • Research Site

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Research Site

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Research Site

    Vancouver, Washington 98684
    United States

    Active - Recruiting

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