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

NCT07221253 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D702NC00001
• Study Type: interventional
• Target: 1,100
• Locations: 19 countries
• Sites: 168

Brief 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.

Conditions

Biliary Tract Cancer

Keywords

Rilvegostomig; Durvalumab; Biliary Tract Cancer; Bispecific Antibody; PD-L1; TIGIT; Initially Unresectable; Recurrent; Intra-hepatic cholangiocarcinoma; Extra-hepatic cholangiocarcinoma; Gallbladder cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 4 years

Secondary Outcomes (16)

• Overall Survival in the intent to treat (ITT) population

  approximately 4 years

• Progression Free Survival (PFS) in the PDL1 ≥ 1% population

  approximately 4 years

• Progression Free Survival (PFS) in the intent to treat (ITT) population

  approximately 4 years

• Objective Response Rate (ORR) in the PDL1 ≥ 1% population

  approximately 4 years

• Objective Response Rate (ORR) in the intent to treat (ITT) population

  approximately 4 years

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Durvalumab IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Drug: Durvalumab; Drug: Gemcitabine/Cisplatin

Experimental Arm

EXPERIMENTAL

Rilvegostomig IV infusion + chemotherapy combination (Gemcitabine/Cisplatin)

Drug: Rilvegostomig; Drug: Gemcitabine/Cisplatin

Interventions

Rilvegostomig DRUG

Rilvegostomig IV (intravenous) Q3W

Also known as: AZD2936

Experimental Arm

Gemcitabine/Cisplatin DRUG

Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle

Control Arm; Experimental Arm

Durvalumab DRUG

Durvalumab 1500mg IV (intravenous) Q3W for up to 8 cycles (21days). Then Q4W.

Also known as: IMFINZI

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (168)

Research Site

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Research Site

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Research Site

Tucson, Arizona, 85719, United States

NOT YET RECRUITING

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Duarte, California, 91010, United States

RECRUITING

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Orange, California, 92868, United States

NOT YET RECRUITING

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Santa Monica, California, 90404, United States

NOT YET RECRUITING

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Stanford, California, 94305-5847, United States

NOT YET RECRUITING

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Aurora, Colorado, 80045, United States

NOT YET RECRUITING

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Hartford, Connecticut, 06102, United States

NOT YET RECRUITING

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New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

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

NOT YET RECRUITING

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

NOT YET RECRUITING

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Jacksonville, Florida, 32209, United States

NOT YET RECRUITING

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Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

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Marietta, Georgia, 30060, United States

RECRUITING

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Chicago, Illinois, 60612, United States

NOT YET RECRUITING

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Chicago, Illinois, 60637, United States

NOT YET RECRUITING

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Louisville, Kentucky, 40207, United States

NOT YET RECRUITING

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Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

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Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

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Detroit, Michigan, 48202, United States

NOT YET RECRUITING

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Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

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Omaha, Nebraska, 68198-5885, United States

NOT YET RECRUITING

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Santa Fe, New Mexico, 87505, United States

RECRUITING

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New York, New York, 10016, United States

NOT YET RECRUITING

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New York, New York, 10032, United States

NOT YET RECRUITING

Research Site

New York, New York, 10065, United States

WITHDRAWN

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Portland, Oregon, 97239, United States

NOT YET RECRUITING

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Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

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Philadelphia, Pennsylvania, 19111, United States

NOT YET RECRUITING

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Pittsburgh, Pennsylvania, 15212, United States

NOT YET RECRUITING

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Providence, Rhode Island, 02903, United States

NOT YET RECRUITING

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Sioux Falls, South Dakota, 57105, United States

RECRUITING

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Darlinghurst, 2010, Australia

RECRUITING

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Gosford, 2250, Australia

NOT YET RECRUITING

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Murdoch, 6150, Australia

NOT YET RECRUITING

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Anderlecht, 1070, Belgium

NOT YET RECRUITING

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Edegem, 2650, Belgium

NOT YET RECRUITING

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Leuven, 3000, Belgium

NOT YET RECRUITING

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Liège, 4000, Belgium

NOT YET RECRUITING

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Roeselare, 8800, Belgium

NOT YET RECRUITING

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Barretos, 14784-400, Brazil

RECRUITING

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Natal, 59075-740, Brazil

RECRUITING

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Porto Alegre, 91350-200, Brazil

RECRUITING

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Ribeirão Preto, 14026-040, Brazil

NOT YET RECRUITING

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São Paulo, 01246-000, Brazil

RECRUITING

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Vitória, 29043-272, Brazil

RECRUITING

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Calgary, Alberta, T2N 5G2, Canada

NOT YET RECRUITING

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Vancouver, British Columbia, VSZ 4E6, Canada

NOT YET RECRUITING

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Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

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Barrie, Ontario, L4M 6M2, Canada

NOT YET RECRUITING

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Toronto, Ontario, M4N 3M5, Canada

RECRUITING

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Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

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Québec, Quebec, G1J 1Z4, Canada

NOT YET RECRUITING

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Beijing, 100020, China

NOT YET RECRUITING

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Beijing, 102218, China

NOT YET RECRUITING

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Changchun, 130021, China

NOT YET RECRUITING

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Changde, 415000, China

RECRUITING

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Changsha, 410005, China

NOT YET RECRUITING

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Changsha, 410013, China

SUSPENDED

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Chengdu, 610078, China

NOT YET RECRUITING

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Fuzhou, 350005, China

RECRUITING

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Guangzhou, 510515, China

NOT YET RECRUITING

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Hangzhou, 310022, China

NOT YET RECRUITING

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Hefei, 230001, China

RECRUITING

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Lishui, 323000, China

WITHDRAWN

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Luoyang, 471023, China

NOT YET RECRUITING

Research Site

Nanchang, 330000, China

NOT YET RECRUITING

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Nanning, 530000, China

NOT YET RECRUITING

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Shandong, China

NOT YET RECRUITING

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Shanghai, 200032, China

NOT YET RECRUITING

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Shenyang, 110016, China

NOT YET RECRUITING

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Weifang, 261000, China

NOT YET RECRUITING

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Wuhan, 430030, China

NOT YET RECRUITING

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Xi'an, 710061, China

NOT YET RECRUITING

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Clichy, 92118, France

NOT YET RECRUITING

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Grenoble, 38043, France

NOT YET RECRUITING

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Marseille, 13385, France

NOT YET RECRUITING

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Vandœuvre-lès-Nancy, 54511, France

NOT YET RECRUITING

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Aachen, 52074, Germany

NOT YET RECRUITING

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Berlin, 10365, Germany

NOT YET RECRUITING

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Berlin, 13353, Germany

NOT YET RECRUITING

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Bonn, 53127, Germany

NOT YET RECRUITING

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Düsseldorf, 40225, Germany

NOT YET RECRUITING

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Essen, 45122, Germany

NOT YET RECRUITING

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Frankfurt, 60488, Germany

NOT YET RECRUITING

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Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

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Hamburg, 20249, Germany

NOT YET RECRUITING

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Hamburg, 22763, Germany

NOT YET RECRUITING

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Heidelberg, 69120, Germany

NOT YET RECRUITING

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Heilbronn, 74078, Germany

NOT YET RECRUITING

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Karlsruhe, 76133, Germany

NOT YET RECRUITING

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Magdeburg, 39120, Germany

NOT YET RECRUITING

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München, 81737, Germany

NOT YET RECRUITING

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Ulm, 89081, Germany

NOT YET RECRUITING

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Delhi, 110029, India

NOT YET RECRUITING

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Hyderabad, 500032, India

NOT YET RECRUITING

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Kolhāpur, 416234, India

NOT YET RECRUITING

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Kolkata, 700063, India

NOT YET RECRUITING

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Mumbai, 400012, India

NOT YET RECRUITING

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Nashik, 422002, India

NOT YET RECRUITING

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Surat, 395002, India

NOT YET RECRUITING

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Castellana Grotte, 70013, Italy

NOT YET RECRUITING

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Milan, 20132, Italy

NOT YET RECRUITING

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Pisa, 56126, Italy

NOT YET RECRUITING

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Rome, 00168, Italy

NOT YET RECRUITING

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Rozzano, 20089, Italy

NOT YET RECRUITING

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Chiba, 260-8717, Japan

RECRUITING

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Kashiwa, 227-8577, Japan

NOT YET RECRUITING

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Kawasaki-shi, 216-8511, Japan

NOT YET RECRUITING

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Kōtoku, 135-8550, Japan

RECRUITING

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Matsuyama, 790-0024, Japan

RECRUITING

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Nagoya, 464-8681, Japan

NOT YET RECRUITING

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Nagoya, 466-8560, Japan

NOT YET RECRUITING

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Osaka, 541-8567, Japan

NOT YET RECRUITING

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Suita-shi, 565-0871, Japan

RECRUITING

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Takatsuki-shi, 569-8686, Japan

RECRUITING

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Ube, 755-8505, Japan

RECRUITING

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Yokohama, 241-8515, Japan

RECRUITING

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Amsterdam, 1081 HV, Netherlands

NOT YET RECRUITING

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Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

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Maastricht, 6202 AZ, Netherlands

NOT YET RECRUITING

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Utrecht, 3584 CX, Netherlands

NOT YET RECRUITING

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Koszalin, 75-581, Poland

NOT YET RECRUITING

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Krakow, 30-688, Poland

NOT YET RECRUITING

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Lodz, 92-213, Poland

NOT YET RECRUITING

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Olsztyn, 10-228, Poland

NOT YET RECRUITING

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Warsaw, 02-034, Poland

NOT YET RECRUITING

Research Site

Busan, 48108, South Korea

RECRUITING

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Daegu, 41404, South Korea

NOT YET RECRUITING

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Seongnam-si, 13496, South Korea

NOT YET RECRUITING

Research Site

Seongnam-si, 13620, South Korea

RECRUITING

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Seoul, 03080, South Korea

RECRUITING

Research Site

Seoul, 03722, South Korea

NOT YET RECRUITING

Research Site

Seoul, 05505, South Korea

RECRUITING

Research Site

Seoul, 06351, South Korea

RECRUITING

Research Site

Seoul, 06591, South Korea

NOT YET RECRUITING

Research Site

Barcelona, 08036, Spain

NOT YET RECRUITING

Research Site

L'Hospitalet de Llobregat, 08908, Spain

NOT YET RECRUITING

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Madrid, 28007, Spain

NOT YET RECRUITING

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Madrid, 28040, Spain

NOT YET RECRUITING

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Santander, 39008, Spain

NOT YET RECRUITING

Research Site

Kaohsiung City, 82445, Taiwan

RECRUITING

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Kaohsiung City, 833, Taiwan

RECRUITING

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Taichung, 40447, Taiwan

RECRUITING

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Taichung, 40705, Taiwan

RECRUITING

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Tainan, 704, Taiwan

RECRUITING

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Taipei, 10002, Taiwan

RECRUITING

Research Site

Taipei, 112, Taiwan

RECRUITING

Research Site

Taoyuan District, 333, Taiwan

RECRUITING

Research Site

Bangkok, 10700, Thailand

NOT YET RECRUITING

Research Site

Chiang Mai, 50200, Thailand

RECRUITING

Research Site

Hat Yai, 90110, Thailand

NOT YET RECRUITING

Research Site

Khon Kaen, 40002, Thailand

RECRUITING

Research Site

Muang, 34000, Thailand

NOT YET RECRUITING

Research Site

Ongkharak, 26120, Thailand

NOT YET RECRUITING

Research Site

Ankara, 06100, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Erzurum, 25240, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Istanbul, 34010, Turkey (Türkiye)

NOT YET RECRUITING

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Konya, 42080, Turkey (Türkiye)

NOT YET RECRUITING

Research Site

Seyhan, 1060, Turkey (Türkiye)

NOT YET RECRUITING

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Birmingham, B15 2GW, United Kingdom

NOT YET RECRUITING

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Glasgow, G12 OYN, United Kingdom

NOT YET RECRUITING

Research Site

Greater London, SW3 6JJ, United Kingdom

NOT YET RECRUITING

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Leeds, LS9 7TF, United Kingdom

NOT YET RECRUITING

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London, NW3 2QG, United Kingdom

NOT YET RECRUITING

Research Site

Manchester, M20 4BX, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Recurrence; Gallbladder Neoplasms

Interventions

durvalumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 27, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): July 4, 2029
• Study Completion (Estimated): July 4, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

IT (5); US (33); TH (6); DE (16); NL (4); FR (4); JP (12); CN (21); ES (5); CA (8); BR (6); BE (5); AU (3); KR (9); TW (8); IN (7); TU (5); GB (6); PL (5)