Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
ARTEMIDE-HCC01
A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
1 other identifier
interventional
1,220
20 countries
220
Brief Summary
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hepatocellular-carcinoma
Started May 2025
Typical duration for phase_3 hepatocellular-carcinoma
220 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedStudy Start
First participant enrolled
May 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2030
July 14, 2026
July 1, 2026
3.9 years
March 26, 2025
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCC
OS is defined as the time from randomisation until the date of death due to any cause.
Up to approximately 6 years
Secondary Outcomes (16)
To demonstrate the efficacy of Arm B relative to Arm C by assessment of OS in participants with advanced HCC
Up to approximately 6 years
To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relative to Arm C in participants with advanced HCC
Up to approximately 6 years
To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relative to Arm C in participants with advanced HCC
Up to approximately 6 years
To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relative to Arm C in participants with advanced HCC
Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
Up to approximately 6 years
- +11 more secondary outcomes
Study Arms (3)
Arm A
EXPERIMENTALTremelimumab , rilvegostomig and bevacizumab
Arm B
EXPERIMENTALRilvegostomig, and bevacizumab
Arm C
ACTIVE COMPARATORAtezolizumab, and bevacizumab
Interventions
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic and/or unresectable HCC
- WHO/ECOG performance status of 0 or 1
- BCLC stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A
- At least one measurable target lesion
- Participants with active HBV infection must receive antiviral therapy for a minimum of 14 days prior to randomization to show evidence of HBV stabilization or signs of viral response.
- Participants with active HCV infection must be well controlled. Participants co-infected with HBV and HCV are not eligible.
- Adequate organ and bone marrow function measured during the screening period.
- Adequate organ and bone marrow function measured during the screening period
- Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
- Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.
You may not qualify if:
- Medical condition
- Any evidence of uncontrolled intercurrent diseases
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
- History of another primary malignancy
- Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
- History of active primary immunodeficiency or active infection
- History of hepatic encephalopathy
- Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
- History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 6 months prior to study randomization.
- Participants with untreated or incompletely treated varices with bleeding or high-risk (red wale signs or other high-risk factors) for bleeding.
- HCC related
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (220)
Research Site
Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85719, United States
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Los Angeles, California, 90095, United States
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Palo Alto, California, 94304, United States
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New Haven, Connecticut, 06520, United States
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Newark, Delaware, 19713, United States
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Jacksonville, Florida, 32224, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Honolulu, Hawaii, 96813, United States
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Chicago, Illinois, 60637, United States
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Indianapolis, Indiana, 46202, United States
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Shreveport, Louisiana, 71103, United States
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Detroit, Michigan, 48202, 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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New Brunswick, New Jersey, 08901, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Cleveland, Ohio, 44195, United States
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Oklahoma City, Oklahoma, 73104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Amarillo, Texas, 79124, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75390, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Tyler, Texas, 75702, United States
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Arlington, Virginia, 22201, United States
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Salem, Virginia, 24153, United States
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Seattle, Washington, 98101, United States
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Milwaukee, Wisconsin, 53226, United States
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Auchenflower, 4066, Australia
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Camperdown, 2050, Australia
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Clayton, 3168, Australia
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Heidelberg, 3084, Australia
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Shatin, 00000, Australia
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Barretos, 14784-400, Brazil
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Porto Alegre, 91350-200, Brazil
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Santa Maria, 97015-450, Brazil
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São Paulo, 04014-002, Brazil
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São Paulo, 05652-9000, Brazil
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Vitória, 29043-272, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Cambridge, Ontario, N1R 3G2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1X6, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Beijing, 100034, China
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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, 610041, China
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Chifeng, 024000, China
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Chongqing, 400010, China
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Deyang, 618000, China
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Fuzhou, 350005, China
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Guangzhou, 510060, China
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Guangzhou, 510515, China
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Guiyang, 550002, China
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Harbin, 150081, China
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Hefei, 230022, China
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Hohhot, 010020, China
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Kunming, 650118, China
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Linyi, 276000, China
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Lishui, 323000, China
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Luoyang, 471000, China
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Nanchang, 330008, China
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Nanchang, 330029, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Nantong, 226361, China
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Neijiang, 641100, 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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Shenyang, 110042, China
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Weifang, 261000, China
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Wenzhou, 325000, China
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Wuhan, 430079, China
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Xi'an, 710100, China
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Zhengzhou, 450008, China
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Clichy, 92118, France
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Lille, 59000, France
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Lyon, 69317, France
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Montpellier, 34090, France
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Nantes, 44093, France
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Nice, 06200, France
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Pessac, 33604, France
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Rennes, 35000, France
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Toulouse, 31059, France
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Aachen, 52074, Germany
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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, 01307, Germany
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Essen, 45122, Germany
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Frankfurt, 60488, Germany
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Frankfurt, 60590, Germany
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Göttingen, 37075, Germany
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Hamburg, 20246, Germany
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Hanover, 30623, Germany
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Leipzig, 4103, Germany
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Lübeck, 23538, Germany
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Magdeburg, 39120, Germany
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Moers, 47441, Germany
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München, 81377, Germany
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Regensburg, 93053, 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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Ahmedabad, 380058, India
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Bangalore, 560027, India
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Binnāguri, 734015, India
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Dehradun, 248016, India
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Delhi, 110029, India
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Hyderabad, 500032, India
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Mumbai, 400012, India
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Nashik, 422011, India
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Vadodara, 391760, India
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20162, Italy
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Palermo, 90127, Italy
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Perugia, 06132, Italy
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Pisa, 56126, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Bunkyō City, 113-8655, Japan
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Chiba, 260-8677, Japan
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Fukuoka, 811-1395, Japan
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Hiroshima, 734-8530, Japan
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Hiroshima, 734-8551, Japan
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Iizuka-shi, 820-8505, Japan
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Kashiwa, 227-8577, Japan
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Kita-gun, 761-0793, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 602-8566, Japan
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Matsuyama, 790-0024, Japan
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Mitaka-shi, 181-8611, Japan
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Morioka, 028-3695, Japan
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Musashino-shi, 180-8610, Japan
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Nagoya, 464-8681, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Saga, 849-8501, Japan
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Sapporo, 006-8555, Japan
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Sendai, 981-0914, Japan
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Suita-shi, 565-0871, Japan
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Tokyo, 104-0045, Japan
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Toyoake-shi, 470-1192, Japan
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Tsu, 514-8507, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1081HV, Netherlands
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Groningen, 9700 RB, Netherlands
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Maastricht, 6229 HX, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Utrecht, 3584 CX, Netherlands
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Gdansk, 80-214, Poland
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Koszalin, 75-581, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-228, Poland
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Warsaw, 02-034, Poland
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Busan, 48108, South Korea
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Goyang-si, 410-769, South Korea
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Gyeonggi-do, 13620, South Korea
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Seongnam-si, 463-712, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 06351, South Korea
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Seoul, 5505, South Korea
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Madrid, 28007, Spain
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Madrid, 28027, Spain
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Madrid, 28040, Spain
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Santander, 39008, Spain
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Changhua, 500, 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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Tainan County, 71044, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Dusit, 10300, Thailand
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Hat Yai, 90110, Thailand
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Muang, 40002, Thailand
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Ubonratchathani, 34000, Thailand
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Altındağ, 06230, Turkey (Türkiye)
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Ankara, 06530, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
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Istanbul, 34180, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE5 9RS, United Kingdom
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London, W12 0HS, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study will be conducted "Sponsor-blinded", Sponsor personnel directly involved in the study conduct will not have access to efficacy data aggregated by intervention arm prior to study unbinding.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2025
First Posted
April 10, 2025
Study Start
May 6, 2025
Primary Completion (Estimated)
March 16, 2029
Study Completion (Estimated)
March 15, 2030
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitmentsmade to the EFPIA PhRMA Data Sharing Principles. For details of ourtimelines, please refer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to theanonymized individual patient-level data via secure research environmentVivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individualpatient-level data from AstraZeneca group of companies sponsoredclinical trials via the request portal Vivli.org. All requests will be evaluatedas per the AZ disclosure commitment:https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does notmean all requests will be shared.