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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Camperdown, Australia, 2050
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Clayton, Australia, 3168
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Murdoch, Australia, 6150
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Westmead, Australia, 2145
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Brussels, Belgium, 1200
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Brussels, Belgium, 1070
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Natal, Brazil, 59075-740
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Porto Alegre, Brazil, 91350-200
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Porto Alegre, Brazil, 90035-000
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Santa Maria, Brazil, 97015-450
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Santo André, Brazil, 09060-870
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São Paulo, Brazil, 01246-000
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São Paulo, Brazil, 01327-001
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Vitória, Brazil, 29043-260
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British Columbia
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Vancouver, British Columbia, Canada, VSZ 4E6
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6C 2R5
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G 2M9
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Toronto, Ontario, Canada, M4N 3M5
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
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Québec, Quebec, Canada, G1J 1Z4
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Beijing, China, 100142
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Beijing, China, CN-100730
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Changchun, China, 130021
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Changsha, China, 410013
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Chengdu, China, 610000
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Chengdu, China, 610072
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Deyang, China, 618000
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Fuzhou, China, 350005
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Guangzhou, China, 510515
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Guiyang, China, 550044
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Hangzhou, China, 310009
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Harbin, China, 150081
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Hefei, China, 230001
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Hefei, China, 230601
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Kunming, China, 650101
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Lanzhou, China, 730000
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Lishui, China, 323000
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Nanchang, China, 330006
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Nanjing, China, 2100008
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Nanjing, China, 210029
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Nanning, China, 530021
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Shandong, China
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Shanghai, China, 201114
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Shenyang, China, 110004
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Tianjin, China, 300060
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Wuhan, China, 430079
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Wuhan, China, 430071
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Xi'an, China, 710061
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Zhengzhou, China, 450008
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Herlev, Denmark, 2730
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Marseille, France, 13273
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Montpellier, France, 34295
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Pessac, France, 33604
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Rennes, France, 35000
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Strasbourg, France, 67033
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Toulouse, France, 31059
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Villejuif, France, 94800
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Berlin, Germany, 13353
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Bonn, Germany, 53127
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Dortmund, Germany, 44137
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Dresden, Germany, 01370
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Erlangen, Germany, 91054
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Esslingen A. N., Germany, 73730
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Frankfurt, Germany, 60488
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Hamburg, Germany, 22763
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Heidelberg, Germany, 69120
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Leipzig, Germany, 4103
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Lübeck, Germany, 23538
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München, Germany, 81377
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München, Germany, 81737
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Münster, Germany, 48129
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Tübingen, Germany, 72076
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Ulm, Germany, 89081
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Hong Kong, Hong Kong, 999077
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Shatin, Hong Kong, 00000
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Delhi, India, 110088
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Kolkata, India, 700094
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Mumbai, India, 400012
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Mysuru, India, 570017
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New Delhi, India, 110085
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New Delhi, India, 110076
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Varanasi, India, 221005
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Florence, Italy, 50134
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Milan, Italy, 20162
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Milan, Italy, 20133
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Padova, Italy, 35128
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Pisa, Italy, 56126
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Rozzano, Italy, 20089
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Tricase, Lecce, Italy, 73039
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Hiroshima, Japan, 734-8551
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Kashiwa, Japan, 227-8577
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Kitaadachi-gun, Japan, 362-0806
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Kōtoku, Japan, 135-8550
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Mitaka-shi, Japan, 181-8611
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Nagoya, Japan, 466-8560
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Nagoya, Japan, 464-8681
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Osaka, Japan, 541-8567
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Sendai, Japan, 980-8574
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Suita-shi, Japan, 565-0871
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Toyama, Japan, 930-0194
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Ube, Japan, 755-8505
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Wakayama, Japan, 641-8510
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Yokohama, Japan, 236-0004
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Yokohama, Japan, 241-8515
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Oslo, Norway, 0379
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Bydgoszcz, Poland, 85-796
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Krakow, Poland, 31-501
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Lublin, Poland, 20-080
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Przemyśl, Poland, 37-700
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Warsaw, Poland, 02-034
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Seongnam-si, South Korea, 13620
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Seoul, South Korea, 03080
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Seoul, South Korea, 03722
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Seoul, South Korea, 05505
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Seoul, South Korea, 06351
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Seoul, South Korea, 06591
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Barcelona, Spain, 08036
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Barcelona, Spain, 8035
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L'Hospitalet de Llobregat, Spain, 08908
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Madrid, Spain, 28041
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Madrid, Spain, 28040
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Madrid, Spain, 28007
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Málaga, Spain, 29011
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Pamplona, Spain, 31005
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Santander, Spain, 39008
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Kaohsiung City, Taiwan, 82445
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Kaohsiung City, Taiwan, 83301
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 70403
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 112
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Taoyuan, Taiwan, 333
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Hat Yai, Thailand, 90110
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Khon Kaen, Thailand, 40002
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Muang, Thailand, 50200
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Muang, Thailand, 34000
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Naimuang, Thailand, 30000
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Si Sa Ket, Thailand, 33000
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Ankara, Turkey (Türkiye), 06100
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Ankara, Turkey (Türkiye), 06230
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Antalya, Turkey (Türkiye), 07100
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Erzurum, Turkey (Türkiye), 25240
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Fatih-Istanbul, Turkey (Türkiye), 34098
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Samsun, Turkey (Türkiye), 55139
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Cambridge, United Kingdom, CB2 0QQ
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Edgbaston, United Kingdom, B15 2WB
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Glasgow, Scotland, United Kingdom, G12 0YN
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London, United Kingdom, NW3 2QG
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Manchester, United Kingdom, M20 4BX
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Sutton, United Kingdom, SM2 5PT
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Alabama
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Birmingham, Alabama, United States, 35233
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Arizona
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Phoenix, Arizona, United States, 85054
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California
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Los Angeles, California, United States, 90089
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Orange, California, United States, 92868
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Stanford, California, United States, 94305
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Colorado
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Aurora, Colorado, United States, 80045
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Littleton, Colorado, United States, 80129
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
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Florida
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Jacksonville, Florida, United States, 32224
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Georgia
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Atlanta, Georgia, United States, 30322
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Illinois
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Chicago, Illinois, United States, 60637
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Iowa
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Iowa City, Iowa, United States, 52242
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Kansas
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Kansas City, Kansas, United States, 66160
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Kentucky
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Lexington, Kentucky, United States, 40506
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Louisiana
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New Orleans, Louisiana, United States, 70121
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Michigan
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Grand Rapids, Michigan, United States, 49503
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Minnesota
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Rochester, Minnesota, United States, 55905
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Missouri
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St Louis, Missouri, United States, 63110
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New York
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Commack, New York, United States, 11725
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Mineola, New York, United States, 11501
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19144
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Texas
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Dallas, Texas, United States, 75246
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic 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 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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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Experimental: Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
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Rilvegostomig IV (intravenous) Q3W
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 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] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles
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Placebo Comparator: Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
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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 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] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles
Placebo IV (intravenous) Q3W
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recurrence free survival (RFS) for Arm A vs. Arm B
Time Frame: Approximately 5 years
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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.
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Approximately 5 years
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Survival (OS) for Arm A vs. Arm B
Time Frame: up to 7 years
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Overall survival is defined as the time from randomization until the date of death due to any cause.
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up to 7 years
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient-reported tolerability Arm A vs. Arm B.
Time Frame: Up to approximately 7 years.
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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.
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Up to approximately 7 years.
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Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.
Time Frame: Up to approximately 7years
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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.
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Up to approximately 7years
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Biliary Tract Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Bile Duct Diseases
- Gallbladder Diseases
- Biliary Tract Neoplasms
- Cholangiocarcinoma
- Bile Duct Neoplasms
- Klatskin Tumor
- Gallbladder Neoplasms
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Nucleic Acids, Nucleotides, and Nucleosides
- Inorganic Chemicals
- Chlorine Compounds
- Nitrogen Compounds
- Deoxycytidine
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Nucleosides
- Uracil
- Pyrimidinones
- Platinum Compounds
- Deoxyribonucleosides
- Fluorouracil
- Capecitabine
- Gemcitabine
- Cisplatin
- Tegafur
- S 1 (combination)
Other Study ID Numbers
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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