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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT06109779

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 155 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT06109779

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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