Biliary Tract CancerPhase 3AB02NCT07221253

A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)

A Phase 3 study testing Rilvegostomig, Durvalumab and Gemcitabine/Cisplatin in people with Biliary Tract Cancer, run by AstraZeneca at 183 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Biliary Tract Cancer
What is being tested?: Rilvegostomig, Durvalumab and Gemcitabine/Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,100 participants
Where: 183 sitesin 19 countries
Study dates: 4 Dec 2025to 31 Jul 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
Adequate bone marrow and organ function.

Who cannot join

Ampullary carcinoma
Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.

Trial locations and contacts

183 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

183 sites in 19 countries

United States42 sites, 40 recruiting

Research Site
Ann Arbor, Michigan, 48109
Not yet recruiting
Research Site
Aurora, Colorado, 80045
Recruiting
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Baltimore, Maryland, 21231
Recruiting
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Birmingham, Alabama, 35233
Recruiting
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Chicago, Illinois, 60612
Not yet recruiting
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Chicago, Illinois, 60637
Recruiting
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Detroit, Michigan, 48202
Not yet recruiting
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Duarte, California, 91010
Recruiting
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Gainesville, Florida, 32610
Recruiting
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Hartford, Connecticut, 06102
Recruiting
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Houston, Texas, 77030
Not yet recruiting
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Indianapolis, Indiana, 46202
Not yet recruiting
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Jacksonville, Florida, 32224
Recruiting
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Lancaster, Pennsylvania, 17601
Recruiting
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Los Angeles, California, 90095
Recruiting
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Louisville, Kentucky, 40217
Recruiting
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Louisville, Kentucky, 40241
Withdrawn
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Marietta, Georgia, 30060
Recruiting
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Miami, Florida, 33176
Not yet recruiting
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Mineola, New York, 11501
Recruiting
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Nashville, Tennessee, 37203
Not yet recruiting
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New Haven, Connecticut, 06510
Recruiting
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New York, New York, 10016
Recruiting
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New York, New York, 10032
Recruiting
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New York, New York, 10065
Withdrawn
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Oklahoma City, Oklahoma, 73104
Not yet recruiting
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Omaha, Nebraska, 68198-5885
Not yet recruiting
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Orange, California, 92868
Recruiting
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Palo Alto, California, 94304
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Philadelphia, Pennsylvania, 19111
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Phoenix, Arizona, 85054
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Pierre, South Dakota, 57501
Recruiting
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Pittsburgh, Pennsylvania, 15212
Recruiting
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Portland, Oregon, 97239
Not yet recruiting
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Providence, Rhode Island, 02903
Recruiting
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Rochester, Minnesota, 55905
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Santa Fe, New Mexico, 87505
Recruiting
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Seattle, Washington, 98104
Not yet recruiting
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Sioux Falls, South Dakota, 57105
Recruiting
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Tucson, Arizona, 85719
Recruiting
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Washington D.C., District of Columbia, 20007
Recruiting
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Washington D.C., District of Columbia, 20037
Not yet recruiting

Other trials in United States

China22 sites, 20 recruiting

Research Site
Beijing, 100020
Recruiting
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Beijing, 102218
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Changchun, 130021
Recruiting
Research Site
Changde, 415000
Recruiting
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Changsha, 410005
Recruiting
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Changsha, 410013
Withdrawn
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Chengdu, 610078
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Fuzhou, 350005
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Guangzhou, 510515
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Hangzhou, 310022
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Hefei, 230001
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Kunming, 650101
Recruiting
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Lishui, 323000
Withdrawn
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Luoyang, 471023
Not yet recruiting
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Nanchang, 330000
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Nanning, 530000
Recruiting
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Shandong
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Shanghai, 200032
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Shenyang, 110016
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Weifang, 261000
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Wuhan, 430030
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Xi'an, 710061
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Other trials in China

Germany17 sites, 17 recruiting

Research Site
Aachen, 52074
Recruiting
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Berlin, 10365
Not yet recruiting
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Berlin, 13353
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Bonn, 53127
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Düsseldorf, 40225
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Essen, 45122
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Frankfurt, 60488
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Freiburg im Breisgau, 79106
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Hamburg, 22297
Not yet recruiting
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Hamburg, 22763
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Heidelberg, 69120
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Heilbronn, 74078
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Karlsruhe, 76133
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Magdeburg, 39120
Not yet recruiting
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München, 81675
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München, 81737
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Research Site
Ulm, 89081
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Other trials in Germany

Japan12 sites, 12 recruiting

Research Site
Chiba, 260-8717
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Kashiwa, 227-8577
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Kawasaki-shi, 216-8511
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Kōtoku, 135-8550
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Matsuyama, 790-0024
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Nagoya, 464-8681
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Nagoya, 466-8560
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Research Site
Osaka, 541-8567
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Research Site
Suita-shi, 565-0871
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Takatsuki-shi, 569-8686
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Ube, 755-8505
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Yokohama, 241-8515
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Other trials in Japan

South Korea9 sites, 9 recruiting

Research Site
Busan, 48108
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Daegu, 41404
Not yet recruiting
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Seongnam-si, 13496
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Seongnam-si, 13620
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06351
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Research Site
Seoul, 06591
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Other trials in South Korea

Canada8 sites, 8 recruiting

Research Site
Barrie, Ontario, L4M 6M2
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Calgary, Alberta, T2N 5G2
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Halifax, Nova Scotia, B3H 2Y9
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Montreal, Quebec, H4A 3J1
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Québec, Quebec, G1J 1Z4
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9
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Vancouver, British Columbia, VSZ 4E6
Not yet recruiting

Other trials in Canada

India8 sites, 7 recruiting

Research Site
Delhi, 110029
Not yet recruiting
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Hyderabad, 500032
Recruiting
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Kolhāpur, 416234
Withdrawn
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Kolkata, 700063
Recruiting
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Kolkata, 700160
Not yet recruiting
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Mumbai, 400012
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Nashik, 422002
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Research Site
Surat, 395002
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Other trials in India

Taiwan8 sites, 8 recruiting

Research Site
Kaohsiung City, 82445
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Kaohsiung City, 833
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Taichung, 40447
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Taichung, 40705
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Tainan, 704
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Taipei, 10002
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Taipei, 112
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Taoyuan, 333
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Other trials in Taiwan

Brazil6 sites, 6 recruiting

Research Site
Barretos, 14784-400
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Natal, 59075-740
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Porto Alegre, 91350-200
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Ribeirão Preto, 14026-040
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São Paulo, 01246-000
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Vitória, 29043-272
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Other trials in Brazil

Poland6 sites, 5 recruiting

Research Site
Koszalin, 75-581
Recruiting
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Krakow, 31-501
Recruiting
Research Site
Lodz, 92-213
Withdrawn
Research Site
Lodz, 92-213
Not yet recruiting
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Olsztyn, 10-228
Recruiting
Research Site
Warsaw, 02-034
Recruiting

Other trials in Poland

Thailand6 sites, 6 recruiting

Research Site
Bangkok, 10700
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Chiang Mai, 50200
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Hat Yai, 90110
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Khon Kaen, 40002
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Muang, 34000
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Ongkharak, 26120
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Other trials in Thailand

United Kingdom6 sites, 6 recruiting

Research Site
Birmingham, B15 2GW
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Glasgow, G12 OYN
Not yet recruiting
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Greater London, SW3 6JJ
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Leeds, LS9 7TF
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London, NW3 2QG
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Manchester, M20 4BX
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Other trials in United Kingdom

Australia5 sites, 5 recruiting

Research Site
Clayton, 3168
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Darlinghurst, 2010
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Gosford, 2250
Recruiting
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Murdoch, 6150
Recruiting
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South Brisbane, 4101
Not yet recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

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Anderlecht, 1070
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Edegem, 2650
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Leuven, 3000
Recruiting
Research Site
Liège, 4000
Recruiting
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Roeselare, 8800
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Other trials in Belgium

Italy5 sites, 5 recruiting

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Castellana Grotte, 70013
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Milan, 20132
Recruiting
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Pisa, 56126
Recruiting
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Rome, 00168
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Rozzano, 20089
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Other trials in Italy

Spain5 sites, 5 recruiting

Research Site
Barcelona, 08036
Recruiting
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L'Hospitalet de Llobregat, 08908
Recruiting
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Madrid, 28007
Recruiting
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Madrid, 28040
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Santander, 39008
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Other trials in Spain

Turkey (Türkiye)5 sites, 5 recruiting

Research Site
Ankara, 06100
Recruiting
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Erzurum, 25240
Recruiting
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Istanbul, 34010
Recruiting
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Konya, 42080
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Seyhan, 1060
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Other trials in Turkey (Türkiye)

France4 sites, 4 recruiting

Research Site
Clichy, 92118
Recruiting
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Grenoble, 38043
Recruiting
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Marseille, 13385
Recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
Recruiting

Other trials in France

Netherlands4 sites, 3 recruiting

Research Site
Amsterdam, 1081 HV
Recruiting
Research Site
Groningen, 9713 GZ
Recruiting
Research Site
Maastricht, 6202 AZ
Recruiting
Research Site
Utrecht, 3584 CX
Withdrawn

Other trials in Netherlands

About this study

Official title: 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)

Conditions: Biliary Tract Cancer
Being tested: Rilvegostomig, Durvalumab, Gemcitabine/Cisplatin
Keywords: Rilvegostomig, Durvalumab, Biliary Tract Cancer, Bispecific Antibody, PD-L1, TIGIT, Initially Unresectable, Recurrent, Intra-hepatic cholangiocarcinoma, Extra-hepatic cholangiocarcinoma, Gallbladder cancer
Medical subject headings: Biliary Tract Neoplasms, Recurrence, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RilvegostomigDrug
Also called AZD2936
Rilvegostomig IV (intravenous) Q3W
DurvalumabDrug
Also called IMFINZI
Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.
Gemcitabine/CisplatinDrug
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Study groups in NCT07221253
Study group	Role	What they receive
Control Arm	Active comparator	Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) Receives: Drug: Durvalumab; Drug: Gemcitabine/Cisplatin
Experimental Arm	Experimental	Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin) Receives: Drug: Rilvegostomig; Drug: Gemcitabine/Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS) in the PDL1 ≥ 1% population
Overall Survival is defined as time from randomization until the date of death due to any cause.
Measured: approximately 4 years

Secondary outcomes (16)

Overall Survival in the intent to treat (ITT) population
Overall Survival is defined as time from randomization until the date of death due to any cause.
Measured: approximately 4 years
Progression Free Survival (PFS) in the PDL1 ≥ 1% population
PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression), whichever occurs first.
Measured: approximately 4 years
Progression Free Survival (PFS) in the intent to treat (ITT) population
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.
Measured: approximately 4 years
Objective Response Rate (ORR) in the PDL1 ≥ 1% population
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.
Measured: approximately 4 years
Objective Response Rate (ORR) in the intent to treat (ITT) population
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR using RECIST 1.1.
Measured: approximately 4 years
Duration of Response (DoR) in the PDL1 ≥ 1% population
DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.
Measured: approximately 4 years
Duration of Response (DoR) in the intent to treat (ITT) population
DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression), whichever occurs first.
Measured: approximately 4 years
Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
Measured: approximately 4 years
Time to Second Progression or death (PFS2) in the intent to treat (ITT) population
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
Measured: approximately 4 years
Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy
Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs and SAEs as assessed by CTCAE v5.0.
Measured: approximately 4 years
Immunogenicity of Rilvegostomig
Presence of ADA for rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).
Measured: approximately 4 years
PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough)
Lowest observed plasma concentration of the study drug (Ctrough) prior to next dose
Measured: Up to 12 weeks after disease progression
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of rilvegostomig
Measured: Up to 12 weeks after disease progression
Serum rilvegostomig concentration
To assess drug exposure (serum concentration) of IV rilvegostomig.
Measured: Up to 12 weeks after disease progression
Assess patient reported biliary tract cancer symptoms (pain)
Patient reported biliary tract cancer symptoms (pain) will be evaluated by the proportion of randomized patients with maintained or improved pain as assessed by the EORTC Item Library 445 and EORTC Item Library 446 (custom questionnaires that include measures of pain-in back, in stomach area, during the night; min/max values from 1-4, with higher scores indicating a worse outcome).
Measured: Up to 12 weeks post disease progression
Assess patient reported global health status/quality of life (GHS/QoL)
Patient reported GHS/QoL will be evaluated by the proportion of randomized patients with maintained or improved GHS/QoL as assessed by the EORTC Item Library 172 (custom questionnaire that includes measures of overall health and overall quality of life; min/max values from 1-7, with higher scores indicating a better outcome).
Measured: Up to 12 weeks post disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202531 Jul 2029

First posted27 Oct 2025
Study start4 Dec 2025
Primary completion31 Jul 2029 (estimated)
Study completion31 Jul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07221253
Sponsor's protocol ID: D702NC00001
Acronym: AB02
Status last verified: Sep 2026
First submitted: 1 Oct 2025
Last updated: 28 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Enrolling by invitationPhase 2
Vedotin for Injection in Second-line or Later Treatment of Advanced Biliary Tract Cancer
Biliary Tract Neoplasms
RecruitingPhase 2
Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node Metastases
Biliary Tract Cancer (BTC), Surgery
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma

All Biliary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07221253
Acronym / sponsor ID: AB02 / D702NC00001
Conditions: Biliary Tract Cancer
Keywords: Rilvegostomig, Durvalumab, Biliary Tract Cancer, Bispecific Antibody, PD-L1, TIGIT, Initially Unresectable, Recurrent
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,100 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Dec 2025 (actual)
Primary completion: 31 Jul 2029 (estimated)
Study completion: 31 Jul 2029 (estimated)
First posted: 27 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control Arm	Active comparator	Drug: Durvalumab, Drug: Gemcitabine/CisplatinDurvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)
Experimental Arm	Experimental	Drug: Rilvegostomig, Drug: Gemcitabine/CisplatinRilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting
Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.

Key exclusion criteria (6 listed)

Ampullary carcinoma
Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.
Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.
Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RilvegostomigAlso: AZD2936Rilvegostomig IV (intravenous) Q3W	Drug	Experimental Arm
DurvalumabAlso: IMFINZIDurvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.	Drug	Control Arm
Gemcitabine/CisplatinGemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle	Drug	Control Arm, Experimental Arm

Primary outcome

Overall Survival (OS) in the PDL1 ≥ 1% population
Time frame: approximately 4 years
Overall Survival is defined as time from randomization until the date of death due to any cause.

16 secondary outcomes

Overall Survival in the intent to treat (ITT) population
Time frame: approximately 4 years
Progression Free Survival (PFS) in the PDL1 ≥ 1% population
Time frame: approximately 4 years
Progression Free Survival (PFS) in the intent to treat (ITT) population
Time frame: approximately 4 years
Objective Response Rate (ORR) in the PDL1 ≥ 1% population
Time frame: approximately 4 years
Objective Response Rate (ORR) in the intent to treat (ITT) population
Time frame: approximately 4 years
Duration of Response (DoR) in the PDL1 ≥ 1% population
Time frame: approximately 4 years
Duration of Response (DoR) in the intent to treat (ITT) population
Time frame: approximately 4 years
Time to Second Progression or death (PFS2) in the PDL1 ≥ 1% population
Time frame: approximately 4 years
Time to Second Progression or death (PFS2) in the intent to treat (ITT) population
Time frame: approximately 4 years
Assess the safety and tolerability of rilvegostomig in combination with chemotherapy vs durvalumab in combination with chemotherapy
Time frame: approximately 4 years
Immunogenicity of Rilvegostomig
Time frame: approximately 4 years
PK of rilvegostomig: Lowest observed concentration of study drug before the next dose is administered (Ctrough)
Time frame: Up to 12 weeks after disease progression
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Time frame: Up to 12 weeks after disease progression
Serum rilvegostomig concentration
Time frame: Up to 12 weeks after disease progression
Assess patient reported biliary tract cancer symptoms (pain)
Time frame: Up to 12 weeks post disease progression
Assess patient reported global health status/quality of life (GHS/QoL)
Time frame: Up to 12 weeks post disease progression

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

183 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilvegostomig, Durvalumab and Gemcitabine/Cisplatin in people with Biliary Tract Cancer, run by AstraZeneca at 183 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, China, Germany, Japan, South Korea and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in the PDL1 ≥ 1% population (time frame: approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07221253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.