Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Biliary Tract Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109779
• Other study ID #: D7025C00001
• Secondary ID: 2023-506054-20-0
• Status: Recruiting
• Phase: Phase 3
• Start date: December 4, 2023
• Est. completion date: September 30, 2030

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: September 30, 2030
• Est. primary completion date: June 29, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• 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

Country	Name	City	State
Australia	Research Site	Clayton
Australia	Research Site	Murdoch
Australia	Research Site	Reservoir
Australia	Research Site	Westmead
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Edegem
Belgium	Research Site	Leuven
Brazil	Research Site	Natal
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Santa Maria
Brazil	Research Site	Santo Andre
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Vitória
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
China	Research Site	Shanghai
Denmark	Research Site	Herlev
France	Research Site	Marseille
France	Research Site	Paris Cedex 5
France	Research Site	Pessac
France	Research Site	Rennes
France	Research Site	Strasbourg
France	Research Site	Toulouse Cedex 9
France	Research Site	Villejuif
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Dortmund
Germany	Research Site	Dresden
Germany	Research Site	Erlangen
Germany	Research Site	Essen
Germany	Research Site	Esslingen
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Köln
Germany	Research Site	Leipzig
Germany	Research Site	Luebeck
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Münster
Germany	Research Site	Stuttgart
Germany	Research Site	Ulm
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Shatin
India	Research Site	Delhi
India	Research Site	Kolkata
India	Research Site	Mumbai
India	Research Site	Mysuru
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Vadodara
India	Research Site	Varanasi
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Padova
Italy	Research Site	Pisa
Italy	Research Site	Rozzano
Italy	Research Site	Tricase, Lecce
Japan	Research Site	Chuo-ku
Japan	Research Site	Kashiwa
Japan	Research Site	Kitaadachi-gun
Japan	Research Site	Nagoya-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Suita-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Norway	Research Site	Oslo
Poland	Research Site	Bydgoszcz
Poland	Research Site	Katowice
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Przemysl
Poland	Research Site	Tomaszów Mazowiecki
Poland	Research Site	Warszawa
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	L'Hospitalet de Llobregat
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Pamplona
Spain	Research Site	Santander
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Muang
Thailand	Research Site	Muang
Thailand	Research Site	Naimuang
Thailand	Research Site	Sisaket
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Erzurum
Turkey	Research Site	Fatih-Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Samsun
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Edgbaston
United Kingdom	Research Site	Glasgow, Scotland
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Sutton
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Chicago	Illinois
United States	Research Site	Commack	New York
United States	Research Site	Dallas	Texas
United States	Research Site	Gainesville	Florida
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kansas City	Kansas
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Mineola	New York
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Orange	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Rochester	Minnesota
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Stanford	California
United States	Research Site	Tyler	Texas
United States	Research Site	Vancouver	Washington
United States	Research Site	Washington	District of Columbia
United States	Research Site	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  Hong Kong,  India,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported tolerability Arm A vs. Arm B.	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.	Up to approximately 7 years.
Other	Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.	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.	Up to approximately 7years
Primary	Recurrence free survival (RFS) for Arm A vs. Arm B	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.	Approximately 5 years
Secondary	Overall Survival (OS) for Arm A vs. Arm B	Overall survival is defined as the time from randomization until the date of death due to any cause.	up to 7 years