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A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
Sponsor: AstraZeneca
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2025-12-04
Completion Date
2029-07-04
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Rilvegostomig
Rilvegostomig IV (intravenous) Q3W
Durvalumab
Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
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
Locations (168)
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Birmingham, Alabama, United States
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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 District, 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
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Ongkharak, Thailand
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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