Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

Bookmark
Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: Dec. 4, 2025

Planned enrollment: 1100

Trial ID: NCT07221253
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

chevron Show for: Rilvegostomig (AZD2936)

TrialFetch AI Analysis

Goal: Determine whether first-line rilvegostomig plus gemcitabine and cisplatin improves efficacy and has acceptable safety compared with durvalumab plus the same chemotherapy in advanced biliary tract cancer.

Patients: Patients with previously untreated, unresectable locally advanced or metastatic intrahepatic or extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma, measurable disease, known centrally assessed PD-L1 status, and ECOG performance status 0–1. Ampullary carcinoma, prior systemic treatment for advanced disease, prior immune-checkpoint therapy, and certain active autoimmune or inflammatory conditions are excluded.

Design: Global, multicenter, randomized, open-label phase III comparison of two first-line regimens.

Treatments: The experimental arm receives intravenous rilvegostomig with gemcitabine and cisplatin; the comparator receives intravenous durvalumab with the same chemotherapy. Rilvegostomig is an investigational bispecific antibody targeting PD-1 and TIGIT to counter two inhibitory immune pathways. Early single-arm studies in non-small-cell lung cancer have shown antitumor responses, including a 29.0% response rate in checkpoint-inhibitor–naïve patients with PD-L1 TPS 1–49% and 61.8% in those with TPS ≥50%; these findings do not establish benefit in biliary tract cancer or superiority over durvalumab. Durvalumab is a PD-L1 inhibitor used with gemcitabine and cisplatin as a first-line regimen for advanced biliary tract cancer.

Outcomes: The primary endpoint is overall survival in patients with PD-L1 expression ≥1%. Secondary endpoints include overall survival in the intention-to-treat population; progression-free survival, objective response, duration of response, and time to second progression or death in both populations; adverse events; rilvegostomig pharmacokinetics and antidrug antibodies; and patient-reported pain and global health status/quality of life.

Burden on patient: Estimated moderate burden. Both arms require intravenous immunotherapy and chemotherapy visits, repeated CT or MRI scans, and safety assessments typical of intensive first-line treatment. Central PD-L1 testing requires an acceptable tumor sample, but a new biopsy is not specified. Additional pharmacokinetic and immunogenicity blood sampling, questionnaires, and follow-up after progression may add visits or time compared with routine care.

Last updated: Sep 2026

Eligibility More information

chevron Show Criteria

Sites (168)

Sort by distance to:
Clear

Research Site

Darlinghurst, 2010, Australia

No email / No phone

Status: Recruiting

Research Site

Vitória, 29043-272, Brazil

No email / No phone

Status: Recruiting

Research Site

Porto Alegre, 91350-200, Brazil

No email / No phone

Status: Recruiting

Research Site

Natal, 59075-740, Brazil

No email / No phone

Status: Recruiting

Research Site

Barretos, 14784-400, Brazil

No email / No phone

Status: Recruiting

Research Site

São Paulo, 01246-000, Brazil

No email / No phone

Status: Recruiting

Research Site

Halifax, Nova Scotia, B3H 2Y9, Canada

No email / No phone

Status: Recruiting

Research Site

Toronto, Ontario, M5G 2M9, Canada

No email / No phone

Status: Recruiting

Research Site

Toronto, Ontario, M4N 3M5, Canada

No email / No phone

Status: Recruiting

Research Site

Fuzhou, 350005, China

No email / No phone

Status: Recruiting

Research Site

Hefei, 230001, China

No email / No phone

Status: Recruiting

Research Site

Changde, 415000, China

No email / No phone

Status: Recruiting

Research Site

Takatsuki-shi, 569-8686, Japan

No email / No phone

Status: Recruiting

Research Site

Ube, 755-8505, Japan

No email / No phone

Status: Recruiting

Research Site

Yokohama, 241-8515, Japan

No email / No phone

Status: Recruiting

Research Site

Chiba, 260-8717, Japan

No email / No phone

Status: Recruiting

Research Site

Kōtoku, 135-8550, Japan

No email / No phone

Status: Recruiting

Research Site

Matsuyama, 790-0024, Japan

No email / No phone

Status: Recruiting

Research Site

Suita-shi, 565-0871, Japan

No email / No phone

Status: Recruiting

Research Site

Seoul, 03080, South Korea

No email / No phone

Status: Recruiting

Research Site

Seoul, 05505, South Korea

No email / No phone

Status: Recruiting

Research Site

Seoul, 06351, South Korea

No email / No phone

Status: Recruiting

Research Site

Busan, 48108, South Korea

No email / No phone

Status: Recruiting

Research Site

Seongnam-si, 13620, South Korea

No email / No phone

Status: Recruiting

Research Site

Taichung, 40705, Taiwan

No email / No phone

Status: Recruiting

Research Site

Kaohsiung City, 82445, Taiwan

No email / No phone

Status: Recruiting

Research Site

Kaohsiung City, 833, Taiwan

No email / No phone

Status: Recruiting

Research Site

Taichung, 40447, Taiwan

No email / No phone

Status: Recruiting

Research Site

Tainan, 704, Taiwan

No email / No phone

Status: Recruiting

Research Site

Taipei, 10002, Taiwan

No email / No phone

Status: Recruiting

Research Site

Taipei, 112, Taiwan

No email / No phone

Status: Recruiting

Research Site

Taoyuan District, 333, Taiwan

No email / No phone

Status: Recruiting

Research Site

Khon Kaen, 40002, Thailand

No email / No phone

Status: Recruiting

Research Site

Chiang Mai, 50200, Thailand

No email / No phone

Status: Recruiting

Research Site

Duarte, California, 91010, United States

No email / No phone

Status: Recruiting

Research Site

Marietta, Georgia, 30060, United States

No email / No phone

Status: Recruiting

Research Site

Santa Fe, New Mexico, 87505, United States

No email / No phone

Status: Recruiting

Research Site

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

Research Site

Murdoch, 6150, Australia

No email / No phone

Status: Not yet recruiting

Research Site

Gosford, 2250, Australia

No email / No phone

Status: Not yet recruiting

Research Site

Anderlecht, 1070, Belgium

No email / No phone

Status: Not yet recruiting

Research Site

Roeselare, 8800, Belgium

No email / No phone

Status: Not yet recruiting

Research Site

Liège, 4000, Belgium

No email / No phone

Status: Not yet recruiting

Research Site

Leuven, 3000, Belgium

No email / No phone

Status: Not yet recruiting

Research Site

Edegem, 2650, Belgium

No email / No phone

Status: Not yet recruiting

Research Site

Ribeirão Preto, 14026-040, Brazil

No email / No phone

Status: Not yet recruiting

Research Site

Calgary, Alberta, T2N 5G2, Canada

No email / No phone

Status: Not yet recruiting

Research Site

Vancouver, British Columbia, VSZ 4E6, Canada

No email / No phone

Status: Not yet recruiting

Research Site

Barrie, Ontario, L4M 6M2, Canada

No email / No phone

Status: Not yet recruiting

Research Site

Québec, Quebec, G1J 1Z4, Canada

No email / No phone

Status: Not yet recruiting

Research Site

Montreal, Quebec, H4A 3J1, Canada

No email / No phone

Status: Not yet recruiting

Research Site

Xi'an, 710061, China

No email / No phone

Status: Not yet recruiting

Research Site

Wuhan, 430030, China

No email / No phone

Status: Not yet recruiting

Research Site

Weifang, 261000, China

No email / No phone

Status: Not yet recruiting

Research Site

Shenyang, 110016, China

No email / No phone

Status: Not yet recruiting

Research Site

Shanghai, 200032, China

No email / No phone

Status: Not yet recruiting

Research Site

Shandong, China

No email / No phone

Status: Not yet recruiting

Research Site

Nanning, 530000, China

No email / No phone

Status: Not yet recruiting

Research Site

Nanchang, 330000, China

No email / No phone

Status: Not yet recruiting

Research Site

Luoyang, 471023, China

No email / No phone

Status: Not yet recruiting

Research Site

Hangzhou, 310022, China

No email / No phone

Status: Not yet recruiting

Research Site

Beijing, 100020, China

No email / No phone

Status: Not yet recruiting

Research Site

Beijing, 102218, China

No email / No phone

Status: Not yet recruiting

Research Site

Changchun, 130021, China

No email / No phone

Status: Not yet recruiting

Research Site

Changsha, 410005, China

No email / No phone

Status: Not yet recruiting

Research Site

Chengdu, 610078, China

No email / No phone

Status: Not yet recruiting

Research Site

Guangzhou, 510515, China

No email / No phone

Status: Not yet recruiting

Research Site

Clichy, 92118, France

No email / No phone

Status: Not yet recruiting

Research Site

Grenoble, 38043, France

No email / No phone

Status: Not yet recruiting

Research Site

Marseille, 13385, France

No email / No phone

Status: Not yet recruiting

Research Site

Vandœuvre-lès-Nancy, 54511, France

No email / No phone

Status: Not yet recruiting

Research Site

Hamburg, 20249, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Hamburg, 22763, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Heidelberg, 69120, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Heilbronn, 74078, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Karlsruhe, 76133, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Magdeburg, 39120, Germany

No email / No phone

Status: Not yet recruiting

Research Site

München, 81737, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Ulm, 89081, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Aachen, 52074, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Berlin, 10365, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Berlin, 13353, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Düsseldorf, 40225, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Bonn, 53127, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Essen, 45122, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Frankfurt, 60488, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Freiburg im Breisgau, 79106, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Delhi, 110029, India

No email / No phone

Status: Not yet recruiting

Research Site

Hyderabad, 500032, India

No email / No phone

Status: Not yet recruiting

Research Site

Kolhāpur, 416234, India

No email / No phone

Status: Not yet recruiting

Research Site

Kolkata, 700063, India

No email / No phone

Status: Not yet recruiting

Research Site

Mumbai, 400012, India

No email / No phone

Status: Not yet recruiting

Research Site

Nashik, 422002, India

No email / No phone

Status: Not yet recruiting

Research Site

Surat, 395002, India

No email / No phone

Status: Not yet recruiting

Research Site

Rome, 00168, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Pisa, 56126, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Milan, 20132, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Castellana Grotte, 70013, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Rozzano, 20089, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Kawasaki-shi, 216-8511, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Kashiwa, 227-8577, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Nagoya, 464-8681, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Nagoya, 466-8560, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Osaka, 541-8567, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Amsterdam, 1081 HV, Netherlands

No email / No phone

Status: Not yet recruiting

Research Site

Utrecht, 3584 CX, Netherlands

No email / No phone

Status: Not yet recruiting

Research Site

Maastricht, 6202 AZ, Netherlands

No email / No phone

Status: Not yet recruiting

Research Site

Groningen, 9713 GZ, Netherlands

No email / No phone

Status: Not yet recruiting

Research Site

Warsaw, 02-034, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Olsztyn, 10-228, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Koszalin, 75-581, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Lodz, 92-213, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Krakow, 30-688, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Seoul, 06591, South Korea

No email / No phone

Status: Not yet recruiting

Research Site

Daegu, 41404, South Korea

No email / No phone

Status: Not yet recruiting

Research Site

Seongnam-si, 13496, South Korea

No email / No phone

Status: Not yet recruiting

Research Site

Seoul, 03722, South Korea

No email / No phone

Status: Not yet recruiting

Research Site

Santander, 39008, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Madrid, 28040, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Madrid, 28007, Spain

No email / No phone

Status: Not yet recruiting

Research Site

L'Hospitalet de Llobregat, 08908, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Barcelona, 08036, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Muang, 34000, Thailand

No email / No phone

Status: Not yet recruiting

Research Site

Ongkharak, 26120, Thailand

No email / No phone

Status: Not yet recruiting

Research Site

Bangkok, 10700, Thailand

No email / No phone

Status: Not yet recruiting

Research Site

Hat Yai, 90110, Thailand

No email / No phone

Status: Not yet recruiting

Research Site

Seyhan, 1060, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Research Site

Konya, 42080, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Research Site

Ankara, 06100, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Research Site

Erzurum, 25240, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Research Site

Istanbul, 34010, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Research Site

Manchester, M20 4BX, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Birmingham, B15 2GW, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Glasgow, G12 OYN, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Greater London, SW3 6JJ, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Leeds, LS9 7TF, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

London, NW3 2QG, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Birmingham, Alabama, 35233, United States

No email / No phone

Status: Not yet recruiting

Research Site

Phoenix, Arizona, 85054, United States

No email / No phone

Status: Not yet recruiting

Research Site

Tucson, Arizona, 85719, United States

No email / No phone

Status: Not yet recruiting

Research Site

Santa Monica, California, 90404, United States

No email / No phone

Status: Not yet recruiting

Research Site

Orange, California, 92868, United States

No email / No phone

Status: Not yet recruiting

Research Site

Stanford, California, 94305-5847, United States

No email / No phone

Status: Not yet recruiting

Research Site

Aurora, Colorado, 80045, United States

No email / No phone

Status: Not yet recruiting

Research Site

Hartford, Connecticut, 06102, United States

No email / No phone

Status: Not yet recruiting

Research Site

New Haven, Connecticut, 06510, United States

No email / No phone

Status: Not yet recruiting

Research Site

Washington D.C., District of Columbia, 20037, United States

No email / No phone

Status: Not yet recruiting

Research Site

Washington D.C., District of Columbia, 20007, United States

No email / No phone

Status: Not yet recruiting

Research Site

Jacksonville, Florida, 32209, United States

No email / No phone

Status: Not yet recruiting

Research Site

Jacksonville, Florida, 32224, United States

No email / No phone

Status: Not yet recruiting

Research Site

Chicago, Illinois, 60612, United States

No email / No phone

Status: Not yet recruiting

Research Site

Chicago, Illinois, 60637, United States

No email / No phone

Status: Not yet recruiting

Research Site

Louisville, Kentucky, 40207, United States

No email / No phone

Status: Not yet recruiting

Research Site

Baltimore, Maryland, 21205, United States

No email / No phone

Status: Not yet recruiting

Research Site

Ann Arbor, Michigan, 48109, United States

No email / No phone

Status: Not yet recruiting

Research Site

Detroit, Michigan, 48202, United States

No email / No phone

Status: Not yet recruiting

Research Site

Rochester, Minnesota, 55905, United States

No email / No phone

Status: Not yet recruiting

Research Site

Omaha, Nebraska, 68198-5885, United States

No email / No phone

Status: Not yet recruiting

Research Site

New York, New York, 10032, United States

No email / No phone

Status: Not yet recruiting

Research Site

New York, New York, 10016, United States

No email / No phone

Status: Not yet recruiting

Research Site

Portland, Oregon, 97239, United States

No email / No phone

Status: Not yet recruiting

Research Site

Pittsburgh, Pennsylvania, 15212, United States

No email / No phone

Status: Not yet recruiting

Research Site

Philadelphia, Pennsylvania, 19111, United States

No email / No phone

Status: Not yet recruiting

Research Site

Philadelphia, Pennsylvania, 19104, United States

No email / No phone

Status: Not yet recruiting

Research Site

Providence, Rhode Island, 02903, United States

No email / No phone

Status: Not yet recruiting

Research Site

Lishui, 323000, China

No email / No phone

Status: Withdrawn

Research Site

New York, New York, 10065, United States

No email / No phone

Status: Withdrawn

Research Site

Changsha, 410013, China

No email / No phone

Status: SUSPENDED

Back to trials list