RecruitingPhase 3NCT07221253

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

Sponsor

AstraZeneca

Enrollment

1,100 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer

Summary

The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ARTEMIDE-Biliary02) is comparing two immunotherapy approaches — rilvegostomig versus durvalumab — combined with chemotherapy as the first treatment for advanced bile duct cancer (cholangiocarcinoma) or gallbladder cancer that cannot be surgically removed. **You may be eligible if...** - You have been confirmed by biopsy to have advanced bile duct or gallbladder cancer that cannot be removed with surgery - You have not yet received any treatment for the advanced/metastatic stage - Your tumor's PD-L1 status has been tested at a central lab - Your tumor has measurable lesions on imaging - Your overall health score (ECOG) is 0 or 1 (fully active or slightly restricted) - Your organ function (blood, liver, kidneys) is adequate **You may NOT be eligible if...** - Your cancer is ampullary carcinoma (a nearby but different type of cancer) - You have already received treatment for advanced/unresectable disease - Your overall health has recently declined significantly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRilvegostomig

Rilvegostomig IV (intravenous) Q3W

DRUGDurvalumab

Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.

DRUGGemcitabine/Cisplatin

Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Locations(168)

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Duarte, California, United States

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Orange, California, United States

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Santa Monica, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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Omaha, Nebraska, United States

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Santa Fe, New Mexico, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Sioux Falls, South Dakota, United States

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Darlinghurst, Australia

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Gosford, Australia

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Murdoch, Australia

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Anderlecht, Belgium

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Edegem, Belgium

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Leuven, Belgium

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Liège, Belgium

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Roeselare, Belgium

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Barretos, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Ribeirão Preto, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Beijing, China

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Beijing, China

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Changchun, China

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Changde, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Hefei, China

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Lishui, China

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Luoyang, China

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Nanchang, China

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Nanning, China

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Shandong, China

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Shanghai, China

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Shenyang, China

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Weifang, China

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Wuhan, China

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Xi'an, China

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Clichy, France

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Grenoble, France

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Marseille, France

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Vandœuvre-lès-Nancy, France

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Aachen, Germany

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Berlin, Germany

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Berlin, Germany

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Bonn, Germany

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Düsseldorf, Germany

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Essen, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Hamburg, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Karlsruhe, Germany

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Magdeburg, Germany

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München, Germany

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Ulm, Germany

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Delhi, India

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Hyderabad, India

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Kolhāpur, India

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Kolkata, India

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Mumbai, India

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Nashik, India

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Surat, India

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Castellana Grotte, Italy

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Milan, Italy

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Pisa, Italy

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Rome, Italy

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Rozzano, Italy

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Chiba, Japan

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Kashiwa, Japan

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Kawasaki-shi, Japan

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Kōtoku, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Nagoya, Japan

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Osaka, Japan

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Suita-shi, Japan

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Takatsuki-shi, Japan

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Ube, Japan

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Yokohama, Japan

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Amsterdam, Netherlands

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Groningen, Netherlands

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Maastricht, Netherlands

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Utrecht, Netherlands

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Koszalin, Poland

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Krakow, Poland

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Lodz, Poland

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Olsztyn, Poland

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Warsaw, Poland

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Busan, South Korea

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Daegu, South Korea

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Seongnam-si, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Madrid, Spain

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Santander, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Hat Yai, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

Research Site

Ongkharak, Thailand

Research Site

Ankara, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Konya, Turkey (Türkiye)

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Seyhan, Turkey (Türkiye)

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Birmingham, United Kingdom

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Glasgow, United Kingdom

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Greater London, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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NCT07221253

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