Clinical trial NCT06109779: Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Biliary Tract Cancer
Keywords: Adenocarcinoma of the biliary tract
Biliary tract Cancer
Gall bladder cancer
Intrahepatic Cholangiocarcinoma
Distal Cholangiocarcinoma
Perihilar Cholangiocarcinoma
Klatskin Tumors
Bile duct cancer
Immunotherapy
Cholangiocarcinoma
Rilvegostomig
S-1
Gemcitabine/cisplatin
Capecitabine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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.

Primary outcomes:
measure: Recurrence free survival (RFS) for Arm A vs. Arm B
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Overall Survival (OS) for Arm A vs. Arm B
timeFrame: up to 7 years
Other outcomes:
measure: Patient-reported tolerability Arm A vs. Arm B.
timeFrame: Up to approximately 7 years.
measure: Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.
timeFrame: Up to approximately 7years
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Duarte
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Stanford
country: United States
facility: Research Site
state: California
city: West Hollywood
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Littleton
country: United States
facility: Research Site
state: Colorado
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Kansas City
country: United States
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state: Kansas
city: Lexington
country: United States
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state: Kentucky
city: New Orleans
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state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
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state: Minnesota
city: Saint Louis
country: United States
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state: Missouri
city: Commack
country: United States
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state: New York
city: Mineola
country: United States
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state: New York
city: Philadelphia
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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country: United States
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city: Dallas
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city: Tyler
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state: Texas
city: Vancouver
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state: Washington
city: Camperdown
country: Australia
facility: Research Site
city: Clayton
country: Australia
facility: Research Site
city: Murdoch
country: Australia
facility: Research Site
city: Reservoir
country: Australia
facility: Research Site
city: Westmead
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Natal
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Santa Maria
country: Brazil
facility: Research Site
city: Santo Andre
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
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city: Sao Paulo
country: Brazil
facility: Research Site
city: Vitória
country: Brazil
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Moncton
country: Canada
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state: New Brunswick
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Brampton
country: Canada
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state: Ontario
city: Kingston
country: Canada
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state: Ontario
city: London
country: Canada
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state: Ontario
city: Mississauga
country: Canada
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state: Ontario
city: Ottawa
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Beijing
country: China
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city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
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city: Changsha
country: China
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city: Chengdu
country: China
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city: Chengdu
country: China
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city: Deyang
country: China
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city: Fuzhou
country: China
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city: Guangzhou
country: China
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city: Guangzhou
country: China
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city: Guiyang
country: China
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city: Hangzhou
country: China
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city: Harbin
country: China
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city: Hefei
country: China
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city: Hefei
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Lishui
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Shandong
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Tianjin Shi
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Paris Cedex 5
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
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city: Villejuif
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
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city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Esslingen A. N.
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
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city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Köln
country: Germany
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city: Leipzig
country: Germany
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city: Lübeck
country: Germany
facility: Research Site
city: München
country: Germany
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city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Hong Kong
country: Hong Kong
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city: Hong Kong
country: Hong Kong
facility: Research Site
city: Shatin
country: Hong Kong
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
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city: Mysuru
country: India
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city: New Delhi
country: India
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city: New Delhi
country: India
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city: Vadodara
country: India
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city: Varanasi
country: India
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Tricase, Lecce
country: Italy
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
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city: Kitaadachi-gun
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Mitaka-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Toyama-shi
country: Japan
facility: Research Site
city: Ube
country: Japan
facility: Research Site
city: Wakayama-shi
country: Japan
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city: Yokohama-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Koszalin
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Przemysl
country: Poland
facility: Research Site
city: Tomaszów Mazowiecki
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
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city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Naimuang
country: Thailand
facility: Research Site
city: Sisaket
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Erzurum
country: Turkey
facility: Research Site
city: Fatih-Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Edgbaston
country: United Kingdom
facility: Research Site
city: Glasgow, Scotland
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
References: