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

NCT06109779 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D7025C000012023-506054-20-00
• Study Type: interventional
• Target: 757
• Locations: 21 countries
• Sites: 177

Brief 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.

Conditions

Biliary Tract Cancer

Keywords

Adenocarcinoma of the biliary tract; Biliary tract Cancer; Gall bladder cancer; Intrahepatic Cholangiocarcinoma; Distal Cholangiocarcinoma; Perihilar Cholangiocarcinoma; Klatskin Tumors; Bile duct cancer; Immunotherapy; Cholangiocarcinoma; Rilvegostomig; S-1; Gemcitabine/cisplatin; Capecitabine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival (OS) for Arm A vs. Arm B

  up to 7 years

Other Outcomes (2)

• Patient-reported tolerability Arm A vs. Arm B.

  Up to approximately 7 years.

• Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.

  Up to approximately 7years

Study Arms (2)

Arm A

EXPERIMENTAL

Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Drug: Rilvegostomig; Drug: Capecitabine; Drug: Gemcitabine/Cisplatin; Drug: S-1 [Tegafur/Oteracil/gimeracil]

Arm B

PLACEBO COMPARATOR

Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Drug: Placebo; Drug: Capecitabine; Drug: Gemcitabine/Cisplatin; Drug: S-1 [Tegafur/Oteracil/gimeracil]

Interventions

Rilvegostomig DRUG

Rilvegostomig IV (intravenous) Q3W

Arm A

Placebo DRUG

Placebo IV (intravenous) Q3W

Arm B

Capecitabine DRUG

Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice

Arm A; Arm B

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

Arm A; Arm B

S-1 [Tegafur/Oteracil/gimeracil] DRUG

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

Arm A; Arm B

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 (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (177)

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Birmingham, Alabama, 35233, United States

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Phoenix, Arizona, 85054, United States

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Los Angeles, California, 90089, United States

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Orange, California, 92868, United States

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Stanford, California, 94305, United States

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Aurora, Colorado, 80045, United States

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Littleton, Colorado, 80129, United States

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

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Jacksonville, Florida, 32224, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60637, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40506, United States

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New Orleans, Louisiana, 70121, United States

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Grand Rapids, Michigan, 49503, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63110, United States

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Commack, New York, 11725, United States

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Mineola, New York, 11501, United States

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Philadelphia, Pennsylvania, 19144, United States

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Dallas, Texas, 75246, United States

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Camperdown, 2050, Australia

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Clayton, 3168, Australia

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Murdoch, 6150, Australia

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Westmead, 2145, Australia

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Natal, 59075-740, Brazil

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Porto Alegre, 90035-000, Brazil

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Porto Alegre, 91350-200, Brazil

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Santa Maria, 97015-450, Brazil

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Santo André, 09060-870, Brazil

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São Paulo, 01246-000, Brazil

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São Paulo, 01327-001, Brazil

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Vitória, 29043-260, Brazil

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Vancouver, British Columbia, VSZ 4E6, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Kingston, Ontario, K7L 2V7, Canada

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London, Ontario, N6C 2R5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Beijing, 100142, China

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Beijing, CN-100730, China

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Changchun, 130021, China

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Changsha, 410013, China

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Chengdu, 610000, China

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Chengdu, 610072, China

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Deyang, 618000, China

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Fuzhou, 350005, China

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Guangzhou, 510515, China

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Guiyang, 550044, China

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Hangzhou, 310009, China

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Harbin, 150081, China

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Hefei, 230001, China

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Hefei, 230601, China

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Kunming, 650101, China

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Lanzhou, 730000, China

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Lishui, 323000, China

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Nanchang, 330006, China

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Nanjing, 2100008, China

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Nanjing, 210029, China

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Nanning, 530021, China

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Shandong, China

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Shanghai, 201114, China

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Shenyang, 110004, China

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Tianjin, 300060, China

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Wuhan, 430071, China

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Wuhan, 430079, China

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Xi'an, 710061, China

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Zhengzhou, 450008, China

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Herlev, 2730, Denmark

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Marseille, 13273, France

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Montpellier, 34295, France

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Pessac, 33604, France

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Rennes, 35000, France

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Strasbourg, 67033, France

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Toulouse, 31059, France

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Villejuif, 94800, France

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Berlin, 13353, Germany

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Bonn, 53127, Germany

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Dortmund, 44137, Germany

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Dresden, 01370, Germany

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Erlangen, 91054, Germany

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Esslingen A. N., 73730, Germany

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Frankfurt, 60488, Germany

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Hamburg, 22763, Germany

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Heidelberg, 69120, Germany

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Leipzig, 4103, Germany

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Lübeck, 23538, Germany

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München, 81377, Germany

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München, 81737, Germany

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Münster, 48129, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Hong Kong, 999077, Hong Kong

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Shatin, 00000, Hong Kong

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Delhi, 110088, India

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Kolkata, 700094, India

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Mumbai, 400012, India

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Mysuru, 570017, India

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New Delhi, 110076, India

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New Delhi, 110085, India

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Varanasi, 221005, India

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Florence, 50134, Italy

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Milan, 20133, Italy

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Milan, 20162, Italy

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Padua, 35128, Italy

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Pisa, 56126, Italy

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Rozzano, 20089, Italy

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Tricase, Lecce, 73039, Italy

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Hiroshima, 734-8551, Japan

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Kashiwa, 227-8577, Japan

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Kitaadachi-gun, 362-0806, Japan

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Kōtoku, 135-8550, Japan

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Mitaka-shi, 181-8611, Japan

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Nagoya, 464-8681, Japan

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Nagoya, 466-8560, Japan

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Osaka, 541-8567, Japan

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Sendai, 980-8574, Japan

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Suita-shi, 565-0871, Japan

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Toyama, 930-0194, Japan

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Ube, 755-8505, Japan

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Wakayama, 641-8510, Japan

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Yokohama, 236-0004, Japan

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Yokohama, 241-8515, Japan

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Oslo, 0379, Norway

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Bydgoszcz, 85-796, Poland

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Krakow, 31-501, Poland

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Lublin, 20-080, Poland

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Przemyśl, 37-700, Poland

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Warsaw, 02-034, Poland

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Seongnam-si, 13620, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Seoul, 06591, South Korea

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Barcelona, 08036, Spain

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Barcelona, 8035, Spain

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L'Hospitalet de Llobregat, 08908, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Málaga, 29011, Spain

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Pamplona, 31005, Spain

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Santander, 39008, Spain

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Kaohsiung City, 82445, Taiwan

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Kaohsiung City, 83301, Taiwan

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Taichung, 40447, Taiwan

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Tainan, 70403, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 112, Taiwan

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Taoyuan District, 333, Taiwan

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Hat Yai, 90110, Thailand

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Khon Kaen, 40002, Thailand

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Muang, 34000, Thailand

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Muang, 50200, Thailand

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Naimuang, 30000, Thailand

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Si Sa Ket, 33000, Thailand

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Ankara, 06100, Turkey (Türkiye)

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Ankara, 06230, Turkey (Türkiye)

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Antalya, 07100, Turkey (Türkiye)

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Erzurum, 25240, Turkey (Türkiye)

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Fatih-Istanbul, 34098, Turkey (Türkiye)

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Samsun, 55139, Turkey (Türkiye)

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Cambridge, CB2 0QQ, United Kingdom

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Edgbaston, B15 2WB, United Kingdom

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Glasgow, Scotland, G12 0YN, United Kingdom

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London, NW3 2QG, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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MeSH Terms

Conditions

Biliary Tract Neoplasms; Gallbladder Neoplasms; Cholangiocarcinoma; Klatskin Tumor; Bile Duct Neoplasms

Interventions

Capecitabine; Gemcitabine; Cisplatin; S 1 (combination); Tegafur

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): May 3, 2030
• Last Updated: March 4, 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

JP (15); US (22); GB (6); NO (1); IT (7); KR (6); CA (9); PL (5); BR (8); IN (7); ES (9); CN (29); DE (16); DK (1); TW (7); AU (4); BE (4); TH (6); FR (7); HK (2); TU (6)