AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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

1-877-240-9479

information.center@astrazeneca.com

226 sites in 20 countries

United States37 sites, 33 recruiting
  • Research Site

    Amarillo, Texas, 79124

    Recruiting
  • Research Site

    Arlington, Virginia, 22201

    Recruiting
  • Research Site

    Atlanta, Georgia, 30318

    Recruiting
  • Research Site

    Atlanta, Georgia, 30322

    Withdrawn
  • Research Site

    Austin, Texas, 78705

    Recruiting
  • Research Site

    Chicago, Illinois, 60637

    Recruiting
  • Research Site

    Cleveland, Ohio, 44195

    Withdrawn
  • Research Site

    Dallas, Texas, 75390

    Withdrawn
  • Research Site

    Denver, Colorado, 80210

    Not yet recruiting
  • Research Site

    Detroit, Michigan, 48202

    Recruiting
  • Research Site

    Grand Rapids, Michigan, 49503

    Recruiting
  • Research Site

    Honolulu, Hawaii, 96813

    Withdrawn
  • Research Site

    Houston, Texas, 77030

    Recruiting
  • Research Site

    Indianapolis, Indiana, 46202

    Not yet 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

    Recruiting
  • Research Site

    New York, New York, 10065

    Not yet recruiting
  • Research Site

    Newark, Delaware, 19713

    Recruiting
  • Research Site

    Oklahoma City, Oklahoma, 73104

    Not yet recruiting
  • Research Site

    Orlando, Florida, 32804

    Not yet recruiting
  • Research Site

    Palo Alto, California, 94304

    Recruiting
  • Research Site

    Philadelphia, Pennsylvania, 19107

    Not yet 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

    Recruiting
  • Research Site

    Shreveport, Louisiana, 71103

    Not yet recruiting
  • Research Site

    St Louis, Missouri, 63108

    Not yet recruiting
  • Research Site

    Tucson, Arizona, 85719

    Recruiting
  • Research Site

    Tyler, Texas, 75702

    Recruiting

Other trials in United States

China35 sites, 35 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

    Recruiting
  • Research Site

    Kunming, 650118

    Not yet 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

    Recruiting

Other trials in China

Japan30 sites, 30 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

    Recruiting

Other trials in Japan

Germany22 sites, 20 recruiting
  • Research Site

    Aachen, 52074

    Recruiting
  • Research Site

    Berlin, 13353

    Recruiting
  • Research Site

    Bonn, 53127

    Recruiting
  • Research Site

    Chemnitz, 09116

    Not yet recruiting
  • Research Site

    Cologne, 50937

    Not yet recruiting
  • Research Site

    Dortmund, 44137

    Recruiting
  • Research Site

    Dresden, 01307

    Recruiting
  • Research Site

    Erlangen, 91054

    Not yet recruiting
  • Research Site

    Essen, 45122

    Recruiting
  • Research Site

    Frankfurt, 60488

    Recruiting
  • Research Site

    Frankfurt, 60590

    Recruiting
  • Research Site

    Göttingen, 37075

    Suspended
  • Research Site

    Hamburg, 20246

    Not yet 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

    Recruiting
  • Research Site

    Munich, 80336

    Not yet recruiting
  • Research Site

    Regensburg, 93053

    Withdrawn
  • Research Site

    Ulm, 89081

    Recruiting

Other trials in Germany

Canada9 sites, 8 recruiting
  • Research Site

    Barrie, Ontario, L4M 6M2

    Recruiting
  • Research Site

    Brampton, Ontario, L6R 3J7

    Recruiting
  • Research Site

    Cambridge, Ontario, N1R 3G2

    Not yet recruiting
  • Research Site

    Edmonton, Alberta, T6G 1Z2

    Recruiting
  • Research Site

    Halifax, Nova Scotia, B3H 1V7

    Not yet recruiting
  • Research Site

    Montreal, Quebec, H2X 0A9

    Recruiting
  • Research Site

    Ottawa, Ontario, K1H 8L6

    Withdrawn
  • Research Site

    Québec, Quebec, G1J 1Z4

    Recruiting
  • Research Site

    Toronto, Ontario, M5G 1X6

    Recruiting

Other trials in Canada

France9 sites, 9 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

    Recruiting

Other trials in France

India9 sites, 8 recruiting
  • Research Site

    Ahmedabad, 380058

    Recruiting
  • Research Site

    Bangalore, 560027

    Withdrawn
  • 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

    Not yet recruiting
  • Research Site

    Mumbai, 400012

    Recruiting
  • Research Site

    Nashik, 422011

    Recruiting
  • Research Site

    Vadodara, 391760

    Recruiting

Other trials in India

Italy8 sites, 8 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

    Recruiting

Other trials in Italy

South Korea8 sites, 8 recruiting
  • Research Site

    Busan, 48108

    Recruiting
  • Research Site

    Goyang-si, 410-769

    Not yet recruiting
  • Research Site

    Gyeonggi-do, 13620

    Not yet recruiting
  • Research Site

    Seongnam-si, 463-712

    Recruiting
  • Research Site

    Seoul, 03080

    Not yet recruiting
  • Research Site

    Seoul, 03722

    Recruiting
  • Research Site

    Seoul, 06351

    Recruiting
  • Research Site

    Seoul, 5505

    Recruiting

Other trials in South Korea

Taiwan8 sites, 8 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

    Recruiting

Other trials in Taiwan

Thailand7 sites, 5 recruiting
  • Research Site

    Bangkok, 10210

    Withdrawn
  • 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

    Recruiting
  • Research Site

    Ubonratchathani, 34000

    Withdrawn

Other trials in Thailand

Brazil6 sites, 6 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

    Recruiting

Other trials in Brazil

Poland6 sites, 6 recruiting
  • Research Site

    Bydgoszcz, 85-796

    Not yet 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

    Recruiting

Other trials in Poland

Spain6 sites, 6 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

    Recruiting

Other trials in Spain

Turkey (Türkiye)6 sites, 5 recruiting
  • Research Site

    Altındağ, 06230

    Recruiting
  • Research Site

    Ankara, 06530

    Recruiting
  • Research Site

    Erzurum, 25240

    Recruiting
  • Research Site

    Istanbul, 34180

    Withdrawn
  • Research Site

    Istanbul, 34899

    Recruiting
  • Research Site

    Izmir, 35100

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom6 sites, 6 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

    Recruiting

Other trials in United Kingdom

Australia5 sites, 5 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

    Recruiting

Other trials in Australia

Netherlands5 sites, 4 recruiting
  • Research Site

    Amsterdam, 1081HV

    Recruiting
  • Research Site

    Groningen, 9700 RB

    Recruiting
  • Research Site

    Maastricht, 6229 HX

    Recruiting
  • Research Site

    Rotterdam, 3015 GD

    Withdrawn
  • Research Site

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Vietnam3 sites, 2 recruiting
  • Research Site

    Hanoi, 100000

    Recruiting
  • Research Site

    Hanoi, 100000

    Withdrawn
  • Research Site

    Ho Chi Minh City, 700000

    Recruiting

Other trials in Vietnam

Hong Kong1 site, 1 recruiting
  • Research Site

    Hong Kong, 999077

    Recruiting

Other trials in Hong Kong

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.

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.

Study groups in NCT06921785
Study groupRoleWhat they receive
Arm AExperimentalTremelimumab , rilvegostomig and bevacizumab
Receives: Drug: Tremelimumab; Drug: Rilvegostomig; Drug: Bevacizumab
Arm BExperimentalRilvegostomig, and bevacizumab
Receives: Drug: Rilvegostomig; Drug: Bevacizumab
Arm CActive comparatorAtezolizumab, and bevacizumab
Receives: Drug: Bevacizumab; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 6 years

Secondary outcomes (16)
  1. 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

  2. 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

  3. 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

  4. 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

  5. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    OS

    Measured: Up to approximately 6 years

  6. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    PFS

    Measured: Up to approximately 6 years

  7. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    ORR

    Measured: Up to approximately 6 years

  8. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    DoR

    Measured: Up to approximately 6 years

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. To investigate the immunogenicity of Arm A and Arm B

    Presence of ADAs for tremelimumab and rilvegostomig

    Measured: Up to approximately 6 years

  16. 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.

  1. First posted10 Apr 2025
  2. Study start6 May 2025
  3. Primary completion15 Mar 2030 (estimated)
  4. Study completion15 Mar 2030 (estimated)

Resources

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)
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.

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.

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