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Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Sponsor: AstraZeneca
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
760
Start Date
2023-12-04
Completion Date
2030-05-03
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Rilvegostomig
Rilvegostomig IV (intravenous) Q3W
Placebo
Placebo IV (intravenous) Q3W
Capecitabine
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
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
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
Locations (176)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Orange, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Littleton, Colorado, 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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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Commack, New York, United States
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Mineola, New York, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Camperdown, Australia
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Clayton, Australia
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Murdoch, Australia
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Westmead, Australia
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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Natal, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Santa Maria, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Vitória, Brazil
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Ottawa, 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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Changsha, China
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Chengdu, China
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Chengdu, China
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Deyang, China
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Fuzhou, China
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Guangzhou, China
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Guiyang, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Hefei, China
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Kunming, China
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Lanzhou, China
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Lishui, China
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Nanchang, China
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Nanjing, China
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Nanjing, 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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Tianjin, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Zhengzhou, China
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Herlev, Denmark
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Marseille, France
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Montpellier, France
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Pessac, France
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Rennes, France
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Strasbourg, France
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Toulouse, France
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Villejuif, France
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Berlin, Germany
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Bonn, Germany
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Dortmund, Germany
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Dresden, Germany
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Erlangen, Germany
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Esslingen A. N., Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Lübeck, Germany
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München, Germany
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München, Germany
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Münster, Germany
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Tübingen, Germany
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Ulm, Germany