Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Launched by ASTRAZENECA · Oct 26, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ARTEMIDE-Biliary01 clinical trial is studying a new treatment called rilvegostomig combined with chemotherapy for patients with biliary tract cancer (BTC) after they have had surgery to remove their tumors. The goal is to see if this new treatment works better than a placebo (a substance with no active medicine) in helping patients stay cancer-free after surgery. This trial is currently recruiting participants aged 65 to 74, and both men and women can join if they have been diagnosed with specific types of BTC and have had their tumors completely or mostly removed through surgery.
To be eligible for the trial, patients need to have a confirmed diagnosis of adenocarcinoma of the biliary tract and must have had surgery recently, with no signs of cancer detected in imaging tests. Participants will need to provide a sample of their tumor from the surgery and be in good overall health to take part. Throughout the trial, participants can expect regular check-ups and monitoring to ensure their safety while they receive either the new treatment or the placebo along with standard chemotherapy. This research could help improve future treatment options for biliary tract cancer, making it an important opportunity for eligible patients.
Gender
ALL
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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Rochester, Minnesota, United States
Hong Kong, , Hong Kong
Dallas, Texas, United States
Nashville, Tennessee, United States
Birmingham, Alabama, United States
Brussels, , Belgium
Edegem, , Belgium
Mumbai, , India
Aurora, Colorado, United States
Denver, Colorado, United States
Dresden, , Germany
Chicago, Illinois, United States
Frankfurt, , Germany
Tuebingen, , Germany
Milano, , Italy
Barcelona, , Spain
Manchester, , United Kingdom
Leuven, , Belgium
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Quebec, , Canada
Padova, , Italy
Madrid, , Spain
New Orleans, Louisiana, United States
Iowa City, Iowa, United States
Philadelphia, Pennsylvania, United States
Montpellier, , France
Erlangen, , Germany
Camperdown, , Australia
Kingston, Ontario, Canada
Essen, , Germany
München, , Germany
Ankara, , Turkey
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Orange, California, United States
Philadelphia, Pennsylvania, United States
Bydgoszcz, , Poland
Saint Louis, Missouri, United States
Herlev, , Denmark
Berlin, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Mineola, New York, United States
Atlanta, Georgia, United States
Stanford, California, United States
Duarte, California, United States
Sutton, , United Kingdom
Münster, , Germany
Ulm, , Germany
Firenze, , Italy
West Hollywood, California, United States
Köln, , Germany
Cambridge, , United Kingdom
Paris Cedex 5, , France
New Delhi, , India
Samsun, , Turkey
Tyler, Texas, United States
Vancouver, Washington, United States
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Stuttgart, , Germany
Málaga, , Spain
Essen, , Germany
Madrid, , Spain
Pessac, , France
Jacksonville, Florida, United States
Moncton, New Brunswick, Canada
Shanghai, , China
Taichung, , Taiwan
Rozzano, , Italy
Bruxelles, , Belgium
Pisa, , Italy
Brampton, Ontario, Canada
Koszalin, , Poland
Birmingham, , United Kingdom
Grand Rapids, Michigan, United States
Halifax, Nova Scotia, Canada
Commack, New York, United States
Newport Beach, California, United States
Mitaka Shi, , Japan
Nagoya Shi, , Japan
Taipei, , Taiwan
Kingston, Ontario, Canada
Quebec, , Canada
Chuo Ku, , Japan
Toulouse Cedex 9, , France
Lublin, , Poland
Clayton, , Australia
Beijing, , China
Hangzhou, , China
Nanjing, , China
Nanning, , China
Dortmund, , Germany
London, , United Kingdom
Kashiwa, , Japan
Koto Ku, , Japan
Shandong, , China
Leipzig, , Germany
Bonn, , Germany
Lublin, , Poland
Marseille, , France
Changchun, , China
Xi'an, , China
Sendai Shi, , Japan
Kraków, , Poland
Santo Andre, , Brazil
Guangzhou, , China
Suita Shi, , Japan
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Gainesville, Florida, United States
Phoenix, Arizona, United States
Montpellier Cedex 5, , France
Murdoch, , Australia
Nanchang, , China
Yokohama Shi, , Japan
Changsha, , China
Nanjing, , China
Sao Paulo, , Brazil
Esslingen, , Germany
Santander, , Spain
Villejuif, , France
Kashiwa, , Japan
Harbin, , China
Zhengzhou, , China
Kitaadachi Gun, , Japan
Yokohama Shi, , Japan
Taoyuan, , Taiwan
Osaka Shi, , Japan
L'hospitalet De Llobregat, , Spain
Hat Yai, , Thailand
Naimuang, , Thailand
Antalya, , Turkey
Lübeck, , Germany
Nagoya Shi, , Japan
Tainan City, , Taiwan
Shatin, , Hong Kong
Wakayama Shi, , Japan
Westmead, , Australia
Hiroshima Shi, , Japan
Kaohsiung, , Taiwan
Khon Kaen, , Thailand
Rennes, , France
Nagoya Shi, , Japan
Samsun, , Turkey
Los Angeles, California, United States
Wuhan, , China
Hefei, , China
Lanzhou, , China
Toyama Shi, , Japan
Istanbul, , Turkey
Madrid, , Spain
Vancouver, British Columbia, Canada
Mississauga, Ontario, Canada
Katowice, , Poland
Tomaszów Mazowiecki, , Poland
Lishui, , China
Chengdu, , China
Ube, , Japan
Hamburg, , Germany
Fuzhou, , China
Santa Maria, , Brazil
Mysuru, , India
Hong Kong, , Hong Kong
Kunming, , China
Oslo, , Norway
Natal, , Brazil
Tricase, Lecce, , Italy
Warszawa, , Poland
Sisaket, , Thailand
Altamonte Springs, Florida, United States
Porto Alegre, , Brazil
Strasbourg, , France
Erzurum, , Turkey
Edgbaston, , United Kingdom
Luebeck, , Germany
Przemysl, , Poland
Vadodara, , India
Glasgow, Scotland, , United Kingdom
Shenyang, , China
Vitória, , Brazil
Varanasi, , India
Deyang, , China
Reservoir, , Australia
Chicago, Illinois, United States
Delhi, , India
Kolkata, , India
Muang, , Thailand
Fatih Istanbul, , Turkey
London, Ontario, Canada
Pamplona, , Spain
Tianjin Shi, , China
Lexington, Kentucky, United States
Samsun, , Turkey
Guiyang, , China
Dresden, , Germany
Esslingen A. N., , Germany
Münster, , Germany
Shanghai, , China
Littleton, Colorado, United States
Shenyang, , China
Oslo, , Norway
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported