Bladder Cancer Clinical Trial
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) 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.
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There are 155 Locations for this study
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85054, United States
Los Angeles California, 90089, United States
Orange California, 92868, United States
Stanford California, 94305, United States
West Hollywood California, 90048, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Gainesville Florida, 32611, United States
Jacksonville Florida, 32224, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40506, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Commack New York, 11725, United States
Mineola New York, 11501, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19144, United States
Dallas Texas, 75246, United States
Tyler Texas, 75702, United States
Vancouver Washington, 98684, United States
Clayton , 3168, Australia
Murdoch , 6150, Australia
Reservoir , 3021, Australia
Westmead , 2145, Australia
Brussels , 1070, Belgium
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Natal , 59075, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 91350, Brazil
Santa Maria , 97015, Brazil
Santo Andre , 09060, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01327, Brazil
Vitória , 29043, Brazil
Vancouver British Columbia, V5Z 4, Canada
Moncton New Brunswick, E1C 6, Canada
Halifax Nova Scotia, B3H 2, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6C 2, Canada
Mississauga Ontario, L5M 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Quebec , G1R 2, Canada
Shanghai , 20003, China
Herlev , 2730, Denmark
Marseille , 13273, France
Paris Cedex 5 , 75248, France
Pessac , 33604, France
Rennes , 35000, France
Strasbourg , 67033, France
Toulouse Cedex 9 , 31059, France
Villejuif , 94800, France
Berlin , 13353, Germany
Bonn , 53127, Germany
Dortmund , 44137, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45122, Germany
Esslingen , 73730, Germany
Frankfurt , 60488, Germany
Hamburg , 22763, Germany
Heidelberg , 69120, Germany
Köln , 50937, Germany
Leipzig , 4103, Germany
Luebeck , 23538, Germany
München , 81377, Germany
München , 81737, Germany
Münster , 48149, Germany
Stuttgart , 70174, Germany
Ulm , 89081, Germany
Hong Kong , 00000, Hong Kong
Hong Kong , 0000, Hong Kong
Hong Kong , , Hong Kong
Shatin , 00000, Hong Kong
Delhi , 11008, India
Kolkata , 70009, India
Mumbai , 40001, India
Mysuru , 57001, India
New Delhi , 11007, India
New Delhi , 11008, India
Vadodara , 39176, India
Varanasi , 22100, India
Firenze , 50134, Italy
Milano , 20133, Italy
Milano , 20162, Italy
Padova , 35128, Italy
Pisa , 56126, Italy
Rozzano , 20089, Italy
Tricase, Lecce , 73039, Italy
Chuo-ku , 104-0, Japan
Kashiwa , 227-8, Japan
Kitaadachi-gun , 362-0, Japan
Nagoya-shi , 464-8, Japan
Osaka-shi , 541-8, Japan
Suita-shi , 565-0, Japan
Yokohama-shi , 241-8, Japan
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Oslo , 450, Norway
Bydgoszcz , 85-79, Poland
Katowice , 40-51, Poland
Kraków , 31-50, Poland
Lublin , 20-08, Poland
Przemysl , 37-70, Poland
Tomaszów Mazowiecki , 97-20, Poland
Warszawa , 02-03, Poland
Barcelona , 08036, Spain
Barcelona , 8035, Spain
L'Hospitalet de Llobregat , 08908, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Málaga , 29011, Spain
Pamplona , 31005, Spain
Santander , 39008, Spain
Kaohsiung , 82445, Taiwan
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan City , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
Hat Yai , 90110, Thailand
Khon Kaen , 40002, Thailand
Muang , 34000, Thailand
Muang , 50200, Thailand
Naimuang , 30000, Thailand
Sisaket , 33000, Thailand
Ankara , 06100, Turkey
Ankara , 06230, Turkey
Ankara , 06620, Turkey
Antalya , 07100, Turkey
Erzurum , 25240, Turkey
Fatih-Istanbul , 34098, Turkey
Istanbul , 34722, Turkey
Samsun , 55270, Turkey
Cambridge , CB2 0, United Kingdom
Edgbaston , B15 2, United Kingdom
Glasgow, Scotland , G12 0, United Kingdom
London , NW3 2, United Kingdom
London , W12 0, United Kingdom
London , WC1E , United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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