Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma (ARTEMIDE-HCC01)

May 7, 2026 updated by: AstraZeneca

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

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

Study Overview

Status

Recruiting

Conditions

Hepatocellular Carcinoma

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the efficacy and tolerability of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line treatment in participants with advanced HCC. The study comprises 2 parts - a safety lead-in and a randomised period. Prior to the start of the randomised period of the study, a single-arm safety lead-in period will be applied to evaluate the safety and tolerability of rilvegostomig in combination with bevacizumab and tremelimumab.

Study Type

Interventional

Enrollment (Estimated)

1220

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Australia
- - Auchenflower, Australia, 4066
    - Recruiting
    - Research Site
  - Camperdown, Australia, 2050
    - Recruiting
    - Research Site
  - Clayton, Australia, 3168
    - Not yet recruiting
    - Research Site
  - Heidelberg, Australia, 3084
    - Recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Santa Maria, Brazil, 97015-450
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04014-002
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05652-9000
    - Recruiting
    - Research Site
  - Vitória, Brazil, 29043-272
    - Recruiting
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Not yet recruiting
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Not yet recruiting
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Recruiting
    - Research Site
  - Brampton, Ontario, Canada, L6R 3J7
    - Not yet recruiting
    - Research Site
  - Cambridge, Ontario, Canada, N1R 3G2
    - Not yet recruiting
    - Research Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Withdrawn
    - Research Site
  - Toronto, Ontario, Canada, M5G 1X6
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H2X 0A9
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1J 1Z4
    - Recruiting
    - Research Site
China
- - Beijing, China, 100142
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100034
    - Not yet recruiting
    - Research Site
  - Beijing, China, CN-100730
    - Not yet recruiting
    - Research Site
  - Changchun, China, 130021
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Not yet recruiting
    - Research Site
  - Chifeng, China, 024000
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400010
    - Not yet recruiting
    - Research Site
  - Deyang, China, 618000
    - Recruiting
    - Research Site
  - Fuzhou, China, 350005
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Recruiting
    - Research Site
  - Guiyang, China, 550002
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Hefei, China, 230022
    - Recruiting
    - Research Site
  - Hohhot, China, 010020
    - Not yet recruiting
    - Research Site
  - Kunming, China, 650118
    - Not yet recruiting
    - Research Site
  - Linyi, China, 276000
    - Recruiting
    - Research Site
  - Lishui, China, 323000
    - Recruiting
    - Research Site
  - Luoyang, China, 471000
    - Recruiting
    - Research Site
  - Nanchang, China, 330029
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330008
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Not yet recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Nantong, China, 226361
    - Recruiting
    - Research Site
  - Neijiang, China, 641100
    - Not yet recruiting
    - Research Site
  - Shandong, China
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 201114
    - Recruiting
    - Research Site
  - Shenyang, China, 110042
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110004
    - Not yet recruiting
    - Research Site
  - Weifang, China, 261000
    - Not yet recruiting
    - Research Site
  - Wenzhou, China, 325000
    - Recruiting
    - Research Site
  - Wuhan, China, 430079
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710100
    - Not yet recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Not yet recruiting
    - Research Site
France
- - Clichy, France, 92118
    - Not yet recruiting
    - Research Site
  - Lille, France, 59000
    - Not yet recruiting
    - Research Site
  - Lyon, France, 69317
    - Recruiting
    - Research Site
  - Nantes, France, 44093
    - Not yet recruiting
    - Research Site
  - Nice, France, 06200
    - Not yet recruiting
    - Research Site
  - Pessac, France, 33604
    - Recruiting
    - Research Site
  - Rennes, France, 35000
    - Not yet recruiting
    - Research Site
  - Toulouse, France, 31059
    - Not yet recruiting
    - Research Site
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Research Site
  - Berlin, Germany, 13353
    - Not yet recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Recruiting
    - Research Site
  - Dortmund, Germany, 44137
    - Recruiting
    - Research Site
  - Dresden, Germany, 01307
    - Recruiting
    - Research Site
  - Essen, Germany, 45122
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60488
    - Recruiting
    - Research Site
  - Frankfurt, Germany, 60590
    - Recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Suspended
    - Research Site
  - Hamburg, Germany, 20246
    - Not yet recruiting
    - Research Site
  - Hanover, Germany, 30623
    - Recruiting
    - Research Site
  - Leipzig, Germany, 4103
    - Not yet recruiting
    - Research Site
  - Lübeck, Germany, 23538
    - Not yet recruiting
    - Research Site
  - Magdeburg, Germany, 39120
    - Recruiting
    - Research Site
  - Moers, Germany, 47441
    - Recruiting
    - Research Site
  - München, Germany, 81377
    - Not yet recruiting
    - Research Site
  - Regensburg, Germany, 93053
    - Withdrawn
    - Research Site
  - Ulm, Germany, 89081
    - Not yet recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Research Site
  - Shatin, Hong Kong, 00000
    - Recruiting
    - Research Site
India
- - Ahmedabad, India, 380058
    - Not yet recruiting
    - Research Site
  - Bangalore, India, 560027
    - Withdrawn
    - Research Site
  - Binnāguri, India, 734015
    - Not yet recruiting
    - Research Site
  - Dehradun, India, 248016
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Hyderabad, India, 500032
    - Not yet recruiting
    - Research Site
  - Mumbai, India, 400012
    - Not yet recruiting
    - Research Site
  - Nashik, India, 422011
    - Not yet recruiting
    - Research Site
  - Vadodara, India, 391760
    - Not yet recruiting
    - Research Site
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - Research Site
  - Milan, Italy, 20132
    - Recruiting
    - Research Site
  - Milan, Italy, 20162
    - Not yet recruiting
    - Research Site
  - Palermo, Italy, 90127
    - Not yet recruiting
    - Research Site
  - Perugia, Italy, 06132
    - Not yet recruiting
    - Research Site
  - Pisa, Italy, 56126
    - Recruiting
    - Research Site
  - Roma, Italy, 00168
    - Not yet recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8655
    - Recruiting
    - Research Site
  - Chiba, Japan, 260-8677
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 811-1395
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8551
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8530
    - Recruiting
    - Research Site
  - Iizuka-shi, Japan, 820-8505
    - Recruiting
    - Research Site
  - Kashiwa, Japan, 227-8577
    - Recruiting
    - Research Site
  - Kita-gun, Japan, 761-0793
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0017
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Recruiting
    - Research Site
  - Kyoto, Japan, 602-8566
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 790-0024
    - Recruiting
    - Research Site
  - Mitaka-shi, Japan, 181-8611
    - Recruiting
    - Research Site
  - Morioka, Japan, 028-3695
    - Recruiting
    - Research Site
  - Musashino-shi, Japan, 180-8610
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Okayama, Japan, 700-8558
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Saga, Japan, 849-8501
    - Recruiting
    - Research Site
  - Sapporo, Japan, 006-8555
    - Recruiting
    - Research Site
  - Sendai, Japan, 981-0914
    - Recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Recruiting
    - Research Site
  - Tokyo, Japan, 104-0045
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
  - Tsu, Japan, 514-8507
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 232-0024
    - Recruiting
    - Research Site
Netherlands
- - Amsterdam, Netherlands, 1081HV
    - Not yet recruiting
    - Research Site
  - Groningen, Netherlands, 9700 RB
    - Recruiting
    - Research Site
  - Maastricht, Netherlands, 6229 HX
    - Recruiting
    - Research Site
  - Rotterdam, Netherlands, 3015 GD
    - Not yet recruiting
    - Research Site
  - Utrecht, Netherlands, 3584 CX
    - Not yet recruiting
    - Research Site
Poland
- - Gdansk, Poland, 80-214
    - Not yet recruiting
    - Research Site
  - Koszalin, Poland, 75-581
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-090
    - Not yet recruiting
    - Research Site
  - Olsztyn, Poland, 10-228
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 02-034
    - Not yet recruiting
    - Research Site
South Korea
- - Busan, South Korea, 48108
    - Not yet recruiting
    - Research Site
  - Goyang-si, South Korea, 410-769
    - Not yet recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13620
    - Not yet recruiting
    - Research Site
  - Seongnam-si, South Korea, 463-712
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Not yet recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Not yet recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Madrid, Spain, 28007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28027
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 500
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 83301
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 70403
    - Recruiting
    - Research Site
  - Tainan County, Taiwan, 71044
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10210
    - Not yet recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Dusit, Thailand, 10300
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 40002
    - Recruiting
    - Research Site
  - Ubonratchathani, Thailand, 34000
    - Not yet recruiting
    - Research Site
Turkey (Türkiye)
- - Altındağ, Turkey (Türkiye), 06230
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06530
    - Recruiting
    - Research Site
  - Erzurum, Turkey (Türkiye), 25240
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34180
    - Withdrawn
    - Research Site
  - Izmir, Turkey (Türkiye), 35100
    - Recruiting
    - Research Site
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Not yet recruiting
    - Research Site
  - Leeds, United Kingdom, LS9 7TF
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, NW3 2QG
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, W12 0HS
    - Recruiting
    - Research Site
  - London, United Kingdom, SE5 9RS
    - Not yet recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Not yet recruiting
    - Research Site
United States
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85719
    - Not yet recruiting
    - Research Site
- California
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Research Site
  - Santa Monica, California, United States, 90404
    - Not yet recruiting
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - Recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Not yet recruiting
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Not yet recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30322
    - Withdrawn
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Not yet recruiting
    - Research Site
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Not yet recruiting
    - Research Site
- Louisiana
  - Shreveport, Louisiana, United States, 71103
    - Not yet recruiting
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Not yet recruiting
    - Research Site
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Research Site
- New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Research Site
- New York
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10029
    - Recruiting
    - Research Site
  - New York, New York, United States, 10032
    - Not yet recruiting
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Withdrawn
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Not yet recruiting
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15232
    - Not yet recruiting
    - Research Site
- Texas
  - Austin, Texas, United States, 78705
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75390
    - Withdrawn
    - Research Site
  - El Paso, Texas, United States, 79902
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77030
    - Not yet recruiting
    - Research Site
  - San Antonio, Texas, United States, 78240
    - Recruiting
    - Research Site
  - Tyler, Texas, United States, 75702
    - Not yet recruiting
    - Research Site
- Virginia
  - Arlington, Virginia, United States, 22201
    - Not yet recruiting
    - Research Site
  - Salem, Virginia, United States, 24153
    - Recruiting
    - Research Site
- Washington
  - Seattle, Washington, United States, 98109
    - Not yet recruiting
    - Research Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Not yet recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Withdrawn
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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)
Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A Tremelimumab , rilvegostomig and bevacizumab	Drug: Tremelimumab IV therapy Drug: Rilvegostomig IV therapy Drug: Bevacizumab IV therapy
Experimental: Arm B Rilvegostomig, and bevacizumab	Drug: Rilvegostomig IV therapy Drug: Bevacizumab IV therapy
Active Comparator: Arm C Atezolizumab, and bevacizumab	Drug: Bevacizumab IV therapy Drug: Atezolizumab IV therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCC Time Frame: Up to approximately 6 years	OS is defined as the time from randomisation until the date of death due to any cause.	Up to approximately 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events (AEs) and serious adverse events (SAEs) Time Frame: Up to approximately 6 years	Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC Time Frame: Up to approximately 6 years	OS	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC Time Frame: Up to approximately 6 years	PFS	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC Time Frame: Up to approximately 6 years	ORR	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC Time Frame: Up to approximately 6 years	DoR	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups Time Frame: Up to approximately 6 years	Association of PD-L1 expression level with: • OS	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups Time Frame: Up to approximately 6 years	Association of PD-L1 expression level with: • PFS per RECIST 1.1	Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups Time Frame: Up to approximately 6 years	Association of PD-L1 expression level with: • ORR per RECIST 1.1	Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups Time Frame: Up to approximately 6 years	Association of PD-L1 expression level with: OS	Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups Time Frame: Up to approximately 6 years	Association of PD-L1 expression level with: PFS per RECIST 1.1	Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups Time Frame: Up to approximately 6 years	Association of PD-L1 expression level with: ORR per RECIST 1.1	Up to approximately 6 years
To investigate the immunogenicity of Arm A and Arm B Time Frame: Up to approximately 6 years	Presence of ADAs for tremelimumab and rilvegostomig	Up to approximately 6 years
To demonstrate the efficacy of Arm B relative to Arm C by assessment of OS in participants with advanced HCC Time Frame: Up to approximately 6 years	OS is defined as the time from randomisation until the date of death due to any cause.	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 Time Frame: Up to approximately 6 years	PFS according to RECIST 1.1	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 Time Frame: Up to approximately 6 years	ORR according to RECIST 1.1	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 Time Frame: Up to approximately 6 years	DoR according to RECIST 1.1	Up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

March 16, 2029

Study Completion (Estimated)

March 15, 2030

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D7029C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Roswell Park Cancer Institute
National Comprehensive Cancer Network

Completed

Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Advanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditions

United States
City of Hope Medical Center
National Cancer Institute (NCI)

Active, not recruiting

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer

Unresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditions

United States
Academic and Community Cancer Research United
National Cancer Institute (NCI)

Terminated

A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab

Unresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditions

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completed

Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Unresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | BCLC Stage C Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC... and other conditions

United States
Roswell Park Cancer Institute
Merck Sharp & Dohme LLC

Completed

Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer

Advanced Adult Hepatocellular Carcinoma | Child-Pugh Class A | Stage III Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular...

United States
Academic and Community Cancer Research United
National Cancer Institute (NCI); Genentech, Inc.

Recruiting

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

Unresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditions

United States
National Cancer Institute (NCI)

Completed

Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Unresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC v7 and other conditions

United States, Canada, Puerto Rico
Roswell Park Cancer Institute

Suspended

Autologous CAR T Cells Targeting GPC3 (RPCAR01) for the Treatment of Advanced or Metastatic GPC3 Expressing Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Refractory Hepatocellular Carcinoma | Metastatic Hepatocellular Carcinoma

United States
Edward Kim
Bristol-Myers Squibb; National Cancer Institute (NCI)

Terminated

BMS-986205 and Nivolumab as First or Second Line Therapy in Treating Patients With Liver Cancer

Unresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditions

United States
Pfizer

Recruiting

Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

Carcinoma, Hepatocellular | Liver Neoplasms | Hepatocellular Carcinoma | Advanced Hepatocellular Carcinoma | Unresectable Hepatocellular Carcinoma | Hepatocellular Cancer | Metastatic Hepatocellular Carcinoma

United States, Japan, Taiwan, Puerto Rico

Clinical Trials on Tremelimumab

Riboscience, LLC.

Recruiting

Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma

Advanced Unresectable Hepatocellular Carcinoma

United States
AstraZeneca

Recruiting

A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab (IMFINZI-subQ)

Solid Tumours

Australia, Poland, Georgia, Taiwan, South Korea
MedImmune LLC

Active, not recruiting

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab)

Unresectable Pleural or Peritoneal Malignant Mesothelioma

United States, Italy, Spain, United Kingdom, Belgium, Canada, France, Hungary, Germany, Australia, Poland, South Africa, Netherlands, Romania, Sweden, Denmark, Israel, South Korea, Russia
Abramson Cancer Center at Penn Medicine

Completed

Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers

Melanoma | Breast Cancer | Pancreatic Cancer | Metastatic | Non Small Cell Lung Cancer (NSCLC)

United States
Georgetown University
AstraZeneca

Recruiting

Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer

Carcinoma, Non-Small Cell Lung

United States
MedImmune LLC

Completed

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

Squamous Cell Carcinoma of the Head and Neck

United States, Canada
Vall d'Hebron Institute of Oncology

Recruiting

Single cEll pRofiling PErsistaNce To ImmuNothErapy (SERPENTINE)

Colorectal Cancer | Endometrial Cancer

Spain
AstraZeneca

Completed

A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours

Advanced Solid Tumors

Japan, Korea, Republic of, Taiwan
MedImmune LLC

Completed

A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Advanced Solid Tumors

United States, Germany, Spain, Canada, France, Korea, Republic of, Israel, Netherlands, United Kingdom
University of California, Irvine

Not yet recruiting

ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu

Esophageal Adenocarcinoma | Solid Tumor, Adult | Malignant Solid Tumor | Stomach Adenocarcinoma

United States

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Tremelimumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations