Hepatocellular CarcinomaPhase 3ARTEMIDE-HCC01NCT06921785
Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
A Phase 3 study testing Tremelimumab, Rilvegostomig and Bevacizumab in people with Hepatocellular Carcinoma, run by AstraZeneca at 226 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Tremelimumab, Rilvegostomig and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 226 sitesin 20 countries
- Study dates
- 6 May 2025to 15 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
226 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
226 sites in 20 countries
United States37 sites, 33 recruiting
- Recruiting
Research Site
Amarillo, Texas, 79124
- Recruiting
Research Site
Arlington, Virginia, 22201
- Recruiting
Research Site
Atlanta, Georgia, 30318
- Withdrawn
Research Site
Atlanta, Georgia, 30322
- Recruiting
Research Site
Austin, Texas, 78705
- Recruiting
Research Site
Chicago, Illinois, 60637
- Withdrawn
Research Site
Cleveland, Ohio, 44195
- Withdrawn
Research Site
Dallas, Texas, 75390
- Not yet recruiting
Research Site
Denver, Colorado, 80210
- Recruiting
Research Site
Detroit, Michigan, 48202
- Recruiting
Research Site
Grand Rapids, Michigan, 49503
- Withdrawn
Research Site
Honolulu, Hawaii, 96813
- Recruiting
Research Site
Houston, Texas, 77030
- Not yet recruiting
Research Site
Indianapolis, Indiana, 46202
- Recruiting
Research Site
Jacksonville, Florida, 32224
- Recruiting
Research Site
Los Angeles, California, 90095
- Recruiting
Research Site
Milwaukee, Wisconsin, 53226
- Recruiting
Research Site
New Brunswick, New Jersey, 08901
- Recruiting
Research Site
New Haven, Connecticut, 06520
- Recruiting
Research Site
New York, New York, 10029
- Recruiting
Research Site
New York, New York, 10032
- Not yet recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Newark, Delaware, 19713
- Not yet recruiting
Research Site
Oklahoma City, Oklahoma, 73104
- Not yet recruiting
Research Site
Orlando, Florida, 32804
- Recruiting
Research Site
Palo Alto, California, 94304
- Not yet recruiting
Research Site
Philadelphia, Pennsylvania, 19107
- Recruiting
Research Site
Phoenix, Arizona, 85054
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Recruiting
Research Site
Salem, Virginia, 24153
- Recruiting
Research Site
San Antonio, Texas, 78240
- Recruiting
Research Site
Seattle, Washington, 98101
- Not yet recruiting
Research Site
Shreveport, Louisiana, 71103
- Not yet recruiting
Research Site
St Louis, Missouri, 63108
- Recruiting
Research Site
Tucson, Arizona, 85719
- Recruiting
Research Site
Tyler, Texas, 75702
China35 sites, 35 recruiting
- Recruiting
Research Site
Beijing, 100034
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Beijing, CN-100730
- Recruiting
Research Site
Changchun, 130021
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Chifeng, 024000
- Recruiting
Research Site
Chongqing, 400010
- Recruiting
Research Site
Deyang, 618000
- Recruiting
Research Site
Fuzhou, 350005
- Recruiting
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Guangzhou, 510515
- Recruiting
Research Site
Guiyang, 550002
- Recruiting
Research Site
Harbin, 150081
- Recruiting
Research Site
Hefei, 230022
- Recruiting
Research Site
Hohhot, 010020
- Not yet recruiting
Research Site
Kunming, 650118
- Recruiting
Research Site
Linyi, 276000
- Recruiting
Research Site
Lishui, 323000
- Recruiting
Research Site
Luoyang, 471000
- Recruiting
Research Site
Nanchang, 330008
- Recruiting
Research Site
Nanchang, 330029
- Recruiting
Research Site
Nanjing, 210029
- Recruiting
Research Site
Nanning, 530021
- Recruiting
Research Site
Nantong, 226361
- Recruiting
Research Site
Neijiang, 641100
- Recruiting
Research Site
Shandong
- Recruiting
Research Site
Shanghai, 201114
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenyang, 110042
- Recruiting
Research Site
Weifang, 261000
- Recruiting
Research Site
Wenzhou, 325000
- Recruiting
Research Site
Wuhan, 430079
- Recruiting
Research Site
Xi'an, 710100
- Recruiting
Research Site
Zhengzhou, 450008
Japan30 sites, 30 recruiting
- Recruiting
Research Site
Bunkyō City, 113-8655
- Recruiting
Research Site
Chiba, 260-8677
- Recruiting
Research Site
Fukuoka, 811-1395
- Recruiting
Research Site
Hiroshima, 734-8530
- Recruiting
Research Site
Hiroshima, 734-8551
- Recruiting
Research Site
Iizuka-shi, 820-8505
- Recruiting
Research Site
Kashiwa, 227-8577
- Recruiting
Research Site
Kita-gun, 761-0793
- Recruiting
Research Site
Kobe, 650-0017
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Kumamoto, 860-8556
- Recruiting
Research Site
Kurume-shi, 830-0011
- Recruiting
Research Site
Kyoto, 602-8566
- Recruiting
Research Site
Matsuyama, 790-0024
- Recruiting
Research Site
Mitaka-shi, 181-8611
- Recruiting
Research Site
Morioka, 028-3695
- Recruiting
Research Site
Musashino-shi, 180-8610
- Recruiting
Research Site
Nagoya, 464-8681
- Recruiting
Research Site
Okayama, 700-8558
- Recruiting
Research Site
Osaka, 541-8567
- Recruiting
Research Site
Osakasayama-shi, 589-8511
- Recruiting
Research Site
Saga, 849-8501
- Recruiting
Research Site
Sapporo, 006-8555
- Recruiting
Research Site
Sendai, 981-0914
- Recruiting
Research Site
Suita-shi, 565-0871
- Recruiting
Research Site
Tokyo, 104-0045
- Recruiting
Research Site
Toyoake-shi, 470-1192
- Recruiting
Research Site
Tsu, 514-8507
- Recruiting
Research Site
Yokohama, 232-0024
- Recruiting
Research Site
Yokohama, 241-8515
Germany22 sites, 20 recruiting
- Recruiting
Research Site
Aachen, 52074
- Recruiting
Research Site
Berlin, 13353
- Recruiting
Research Site
Bonn, 53127
- Not yet recruiting
Research Site
Chemnitz, 09116
- Not yet recruiting
Research Site
Cologne, 50937
- Recruiting
Research Site
Dortmund, 44137
- Recruiting
Research Site
Dresden, 01307
- Not yet recruiting
Research Site
Erlangen, 91054
- Recruiting
Research Site
Essen, 45122
- Recruiting
Research Site
Frankfurt, 60488
- Recruiting
Research Site
Frankfurt, 60590
- Suspended
Research Site
Göttingen, 37075
- Not yet recruiting
Research Site
Hamburg, 20246
- Recruiting
Research Site
Hanover, 30623
- Recruiting
Research Site
Leipzig, 4103
- Recruiting
Research Site
Lübeck, 23538
- Recruiting
Research Site
Magdeburg, 39120
- Recruiting
Research Site
Moers, 47441
- Recruiting
Research Site
München, 81377
- Not yet recruiting
Research Site
Munich, 80336
- Withdrawn
Research Site
Regensburg, 93053
- Recruiting
Research Site
Ulm, 89081
Canada9 sites, 8 recruiting
- Recruiting
Research Site
Barrie, Ontario, L4M 6M2
- Recruiting
Research Site
Brampton, Ontario, L6R 3J7
- Not yet recruiting
Research Site
Cambridge, Ontario, N1R 3G2
- Recruiting
Research Site
Edmonton, Alberta, T6G 1Z2
- Not yet recruiting
Research Site
Halifax, Nova Scotia, B3H 1V7
- Recruiting
Research Site
Montreal, Quebec, H2X 0A9
- Withdrawn
Research Site
Ottawa, Ontario, K1H 8L6
- Recruiting
Research Site
Québec, Quebec, G1J 1Z4
- Recruiting
Research Site
Toronto, Ontario, M5G 1X6
France9 sites, 9 recruiting
- Recruiting
Research Site
Clichy, 92118
- Recruiting
Research Site
Lille, 59000
- Recruiting
Research Site
Lyon, 69317
- Recruiting
Research Site
Montpellier, 34090
- Recruiting
Research Site
Nantes, 44093
- Recruiting
Research Site
Nice, 06200
- Recruiting
Research Site
Pessac, 33604
- Recruiting
Research Site
Rennes, 35000
- Recruiting
Research Site
Toulouse, 31059
India9 sites, 8 recruiting
- Recruiting
Research Site
Ahmedabad, 380058
- Withdrawn
Research Site
Bangalore, 560027
- Not yet recruiting
Research Site
Binnāguri, 734015
- Not yet recruiting
Research Site
Dehradun, 248016
- Not yet recruiting
Research Site
Delhi, 110029
- Not yet recruiting
Research Site
Hyderabad, 500032
- Recruiting
Research Site
Mumbai, 400012
- Recruiting
Research Site
Nashik, 422011
- Recruiting
Research Site
Vadodara, 391760
Italy8 sites, 8 recruiting
- Recruiting
Research Site
Bologna, 40138
- Recruiting
Research Site
Milan, 20132
- Recruiting
Research Site
Milan, 20162
- Recruiting
Research Site
Palermo, 90127
- Recruiting
Research Site
Perugia, 06132
- Recruiting
Research Site
Pisa, 56126
- Recruiting
Research Site
Roma, 00168
- Recruiting
Research Site
Rozzano, 20089
South Korea8 sites, 8 recruiting
- Recruiting
Research Site
Busan, 48108
- Not yet recruiting
Research Site
Goyang-si, 410-769
- Not yet recruiting
Research Site
Gyeonggi-do, 13620
- Recruiting
Research Site
Seongnam-si, 463-712
- Not yet recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 5505
Taiwan8 sites, 8 recruiting
- Recruiting
Research Site
Changhua, 500
- Recruiting
Research Site
Kaohsiung City, 83301
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Tainan, 70403
- Recruiting
Research Site
Tainan County, 71044
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 112
- Recruiting
Research Site
Taoyuan, 333
Thailand7 sites, 5 recruiting
- Withdrawn
Research Site
Bangkok, 10210
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Chiang Mai, 50200
- Recruiting
Research Site
Dusit, 10300
- Recruiting
Research Site
Hat Yai, 90110
- Recruiting
Research Site
Muang, 40002
- Withdrawn
Research Site
Ubonratchathani, 34000
Brazil6 sites, 6 recruiting
- Recruiting
Research Site
Barretos, 14784-400
- Recruiting
Research Site
Porto Alegre, 91350-200
- Recruiting
Research Site
Santa Maria, 97015-450
- Recruiting
Research Site
São Paulo, 04014-002
- Recruiting
Research Site
São Paulo, 05652-9000
- Recruiting
Research Site
Vitória, 29043-272
Poland6 sites, 6 recruiting
- Not yet recruiting
Research Site
Bydgoszcz, 85-796
- Recruiting
Research Site
Gdansk, 80-214
- Recruiting
Research Site
Koszalin, 75-581
- Recruiting
Research Site
Lublin, 20-090
- Recruiting
Research Site
Olsztyn, 10-228
- Recruiting
Research Site
Warsaw, 02-034
Spain6 sites, 6 recruiting
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Madrid, 28007
- Recruiting
Research Site
Madrid, 28027
- Recruiting
Research Site
Madrid, 28040
- Recruiting
Research Site
Santander, 39008
Turkey (Türkiye)6 sites, 5 recruiting
- Recruiting
Research Site
Altındağ, 06230
- Recruiting
Research Site
Ankara, 06530
- Recruiting
Research Site
Erzurum, 25240
- Withdrawn
Research Site
Istanbul, 34180
- Recruiting
Research Site
Istanbul, 34899
- Recruiting
Research Site
Izmir, 35100
United Kingdom6 sites, 6 recruiting
- Recruiting
Research Site
Cambridge, CB2 0QQ
- Recruiting
Research Site
Leeds, LS9 7TF
- Recruiting
Research Site
London, NW3 2QG
- Recruiting
Research Site
London, SE5 9RS
- Recruiting
Research Site
London, W12 0HS
- Recruiting
Research Site
Manchester, M20 4BX
Australia5 sites, 5 recruiting
- Recruiting
Research Site
Camperdown, 2050
- Recruiting
Research Site
Clayton, 3168
- Recruiting
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Randwick, 2031
- Recruiting
Research Site
South Brisbane, 4101
Netherlands5 sites, 4 recruiting
- Recruiting
Research Site
Amsterdam, 1081HV
- Recruiting
Research Site
Groningen, 9700 RB
- Recruiting
Research Site
Maastricht, 6229 HX
- Withdrawn
Research Site
Rotterdam, 3015 GD
- Recruiting
Research Site
Utrecht, 3584 CX
Vietnam3 sites, 2 recruiting
- Recruiting
Research Site
Hanoi, 100000
- Withdrawn
Research Site
Hanoi, 100000
- Recruiting
Research Site
Ho Chi Minh City, 700000
About this study
Official title: 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
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Tremelimumab, Rilvegostomig, Bevacizumab, Atezolizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
IV therapy
RilvegostomigDrug
IV therapy
BevacizumabDrug
IV therapy
AtezolizumabDrug
IV therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Tremelimumab , rilvegostomig and bevacizumab Receives: Drug: Tremelimumab; Drug: Rilvegostomig; Drug: Bevacizumab |
| Arm B | Experimental | Rilvegostomig, and bevacizumab Receives: Drug: Rilvegostomig; Drug: Bevacizumab |
| Arm C | Active comparator | Atezolizumab, and bevacizumab Receives: Drug: Bevacizumab; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: 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
PFS according to RECIST 1.1
Measured: 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
ORR according to RECIST 1.1
Measured: 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
DoR according to RECIST 1.1
Measured: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
OS
Measured: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
PFS
Measured: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
ORR
Measured: Up to approximately 6 years
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
DoR
Measured: 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
Association of PD-L1 expression level with:
- OS
Measured: 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
Association of PD-L1 expression level with:
- PFS per RECIST 1.1
Measured: 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
Association of PD-L1 expression level with:
- ORR per RECIST 1.1
Measured: 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
Association of PD-L1 expression level with:
OS
Measured: 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
Association of PD-L1 expression level with:
PFS per RECIST 1.1
Measured: 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
Association of PD-L1 expression level with:
ORR per RECIST 1.1
Measured: Up to approximately 6 years
To investigate the immunogenicity of Arm A and Arm B
Presence of ADAs for tremelimumab and rilvegostomig
Measured: Up to approximately 6 years
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start6 May 2025
- Primary completion15 Mar 2030 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921785
- Sponsor's protocol ID
- D7029C00001
- Acronym
- ARTEMIDE-HCC01
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06921785
- Acronym / sponsor ID
- ARTEMIDE-HCC01 / D7029C00001
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 15 Mar 2030 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Tremelimumab, Drug: Rilvegostomig, Drug: BevacizumabTremelimumab , rilvegostomig and bevacizumab |
| Arm B | Experimental | Drug: Rilvegostomig, Drug: BevacizumabRilvegostomig, and bevacizumab |
| Arm C | Active comparator | Drug: Bevacizumab, Drug: AtezolizumabAtezolizumab, and bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TremelimumabIV therapy | Drug | Arm A |
| RilvegostomigIV therapy | Drug | Arm A, Arm B |
| BevacizumabIV therapy | Drug | Arm A, Arm B, Arm C |
| AtezolizumabIV therapy | Drug | Arm C |
Primary outcome
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.
16 secondary outcomes
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
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
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
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
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
Time frame: 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
To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC
Time frame: 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
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
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
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
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
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
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
To investigate the immunogenicity of Arm A and Arm B
Time frame: Up to approximately 6 years
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to approximately 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
226 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tremelimumab, Rilvegostomig and Bevacizumab in people with Hepatocellular Carcinoma, run by AstraZeneca at 226 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 226 sites in United States, China, Japan, Germany, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.