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

NCT ID: NCT06921785

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2030-03-14

Brief Summary

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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

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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

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The study will be conducted "Sponsor-blinded", Sponsor personnel directly involved in the study conduct will not have access to efficacy data aggregated by intervention arm prior to study unbinding.

Study Groups

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Arm A

Tremelimumab , rilvegostomig and bevacizumab

Group Type EXPERIMENTAL

Tremelimumab

Intervention Type DRUG

IV therapy

Rilvegostomig

Intervention Type DRUG

IV therapy

Bevacizumab

Intervention Type DRUG

IV therapy

Arm B

Rilvegostomig, and bevacizumab

Group Type EXPERIMENTAL

Rilvegostomig

Intervention Type DRUG

IV therapy

Bevacizumab

Intervention Type DRUG

IV therapy

Arm C

Atezolizumab, and bevacizumab

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

IV therapy

Atezolizumab

Intervention Type DRUG

IV therapy

Interventions

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Tremelimumab

IV therapy

Intervention Type DRUG

Rilvegostomig

IV therapy

Intervention Type DRUG

Bevacizumab

IV therapy

Intervention Type DRUG

Atezolizumab

IV therapy

Intervention Type DRUG

Eligibility Criteria

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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
* co-infected with HBV and HCV are not eligible
* 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

Bleeding or other risks

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Research Site

Tucson, Arizona, United States

Site Status NOT_YET_RECRUITING

Research Site

Palo Alto, California, United States

Site Status RECRUITING

Research Site

Santa Monica, California, United States

Site Status NOT_YET_RECRUITING

Research Site

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Research Site

Newark, Delaware, United States

Site Status NOT_YET_RECRUITING

Research Site

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

Research Site

Atlanta, Georgia, United States

Site Status WITHDRAWN

Research Site

Fayetteville, Georgia, United States

Site Status NOT_YET_RECRUITING

Research Site

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Research Site

Shreveport, Louisiana, United States

Site Status NOT_YET_RECRUITING

Research Site

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Research Site

Grand Rapids, Michigan, United States

Site Status RECRUITING

Research Site

Rochester, Minnesota, United States

Site Status NOT_YET_RECRUITING

Research Site

New Brunswick, New Jersey, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Research Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Research Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Research Site

Cleveland, Ohio, United States

Site Status WITHDRAWN

Research Site

Oklahoma City, Oklahoma, United States

Site Status WITHDRAWN

Research Site

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Research Site

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Research Site

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Dallas, Texas, United States

Site Status WITHDRAWN

Research Site

El Paso, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

San Antonio, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Tyler, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Blacksburg, Virginia, United States

Site Status NOT_YET_RECRUITING

Research Site

Fairfax, Virginia, United States

Site Status NOT_YET_RECRUITING

Research Site

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Research Site

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Research Site

Auchenflower, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Camperdown, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Heidelberg, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Porto Alegre, , Brazil

Site Status RECRUITING

Research Site

Santa Maria, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status RECRUITING

Research Site

Vitória, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

Research Site

Halifax, Nova Scotia, Canada

Site Status NOT_YET_RECRUITING

Research Site

Barrie, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Brampton, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Cambridge, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Ottawa, Ontario, Canada

Site Status WITHDRAWN

Research Site

Toronto, Ontario, Canada

Site Status RECRUITING

Research Site

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Research Site

Québec, Quebec, Canada

Site Status NOT_YET_RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Changchun, , China

Site Status NOT_YET_RECRUITING

Research Site

Changsha, , China

Site Status NOT_YET_RECRUITING

Research Site

Chengdu, , China

Site Status NOT_YET_RECRUITING

Research Site

Chifeng, , China

Site Status NOT_YET_RECRUITING

Research Site

Chongqing, , China

Site Status NOT_YET_RECRUITING

Research Site

Deyang, , China

Site Status RECRUITING

Research Site

Fuzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Guangzhou, , China

Site Status RECRUITING

Research Site

Guiyang, , China

Site Status NOT_YET_RECRUITING

Research Site

Harbin, , China

Site Status NOT_YET_RECRUITING

Research Site

Hefei, , China

Site Status NOT_YET_RECRUITING

Research Site

Hohhot, , China

Site Status NOT_YET_RECRUITING

Research Site

Kunming, , China

Site Status NOT_YET_RECRUITING

Research Site

Linyi, , China

Site Status NOT_YET_RECRUITING

Research Site

Lishui, , China

Site Status RECRUITING

Research Site

Luoyang, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanchang, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanchang, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanjing, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanning, , China

Site Status NOT_YET_RECRUITING

Research Site

Nantong, , China

Site Status NOT_YET_RECRUITING

Research Site

Neijiang, , China

Site Status NOT_YET_RECRUITING

Research Site

Shandong, , China

Site Status NOT_YET_RECRUITING

Research Site

Shanghai, , China

Site Status RECRUITING

Research Site

Shenyang, , China

Site Status NOT_YET_RECRUITING

Research Site

Shenyang, , China

Site Status NOT_YET_RECRUITING

Research Site

Weifang, , China

Site Status NOT_YET_RECRUITING

Research Site

Wenzhou, , China

Site Status RECRUITING

Research Site

Wuhan, , China

Site Status NOT_YET_RECRUITING

Research Site

Xi'an, , China

Site Status NOT_YET_RECRUITING

Research Site

Zhengzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Clichy, , France

Site Status NOT_YET_RECRUITING

Research Site

Lille, , France

Site Status NOT_YET_RECRUITING

Research Site

Lyon, , France

Site Status NOT_YET_RECRUITING

Research Site

Nantes, , France

Site Status NOT_YET_RECRUITING

Research Site

Nice, , France

Site Status NOT_YET_RECRUITING

Research Site

Pessac, , France

Site Status NOT_YET_RECRUITING

Research Site

Rennes, , France

Site Status NOT_YET_RECRUITING

Research Site

Toulouse, , France

Site Status NOT_YET_RECRUITING

Research Site

Aachen, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Berlin, , Germany

Site Status NOT_YET_RECRUITING

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Bonn, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Dortmund, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Dresden, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Essen, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Frankfurt, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Frankfurt, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Göttingen, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Hanover, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Lübeck, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Magdeburg, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Moers, , Germany

Site Status NOT_YET_RECRUITING

Research Site

München, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Regensburg, , Germany

Site Status WITHDRAWN

Research Site

Ulm, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Hong Kong, , Hong Kong

Site Status RECRUITING

Research Site

Shatin, , Hong Kong

Site Status RECRUITING

Research Site

Ahmedabad, , India

Site Status NOT_YET_RECRUITING

Research Site

Bangalore, , India

Site Status NOT_YET_RECRUITING

Research Site

Binnāguri, , India

Site Status NOT_YET_RECRUITING

Research Site

Dehradun, , India

Site Status NOT_YET_RECRUITING

Research Site

Delhi, , India

Site Status NOT_YET_RECRUITING

Research Site

Hyderabad, , India

Site Status NOT_YET_RECRUITING

Research Site

Mumbai, , India

Site Status NOT_YET_RECRUITING

Research Site

Nashik, , India

Site Status NOT_YET_RECRUITING

Research Site

Vadodara, , India

Site Status NOT_YET_RECRUITING

Research Site

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Milan, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Milan, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Perugia, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Pisa, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Roma, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Rozzano, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Bunkyō City, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Chiba, , Japan

Site Status RECRUITING

Research Site

Fukuoka, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Hiroshima, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Hiroshima, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Iizuka-shi, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kashiwa, , Japan

Site Status RECRUITING

Research Site

Kita-gun, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kobe, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kōtoku, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kumamoto, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kurume-shi, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Kyoto, , Japan

Site Status RECRUITING

Research Site

Matsuyama, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Mitaka-shi, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Morioka, , Japan

Site Status RECRUITING

Research Site

Musashino-shi, , Japan

Site Status RECRUITING

Research Site

Nagoya, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Okayama, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Osaka, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Osakasayama-shi, , Japan

Site Status RECRUITING

Research Site

Saga, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Sapporo, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Sendai, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Suita-shi, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Tokyo, , Japan

Site Status RECRUITING

Research Site

Toyoake-shi, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Tsu, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Yokohama, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Yokohama, , Japan

Site Status RECRUITING

Research Site

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Research Site

Groningen, , Netherlands

Site Status NOT_YET_RECRUITING

Research Site

Maastricht, , Netherlands

Site Status NOT_YET_RECRUITING

Research Site

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Research Site

Utrecht, , Netherlands

Site Status NOT_YET_RECRUITING

Research Site

Busan, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Goyang-si, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Gyeonggi-do, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Seongnam-si, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Santander, , Spain

Site Status NOT_YET_RECRUITING

Research Site

Changhua, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Taichung, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Tainan, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Tainan County, , Taiwan

Site Status NOT_YET_RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taoyuan District, , Taiwan

Site Status RECRUITING

Research Site

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Chiang Mai, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Dusit, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Hat Yai, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Muang, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Ubonratchathani, , Thailand

Site Status NOT_YET_RECRUITING

Research Site

Altındağ, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Research Site

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Research Site

Erzurum, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Research Site

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Research Site

Izmir, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Research Site

Cambridge, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Manchester, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Hanoi, , Vietnam

Site Status NOT_YET_RECRUITING

Research Site

Ho Chi Minh City, , Vietnam

Site Status NOT_YET_RECRUITING

Countries

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United States Australia Brazil Canada China France Germany Hong Kong India Italy Japan Netherlands South Korea Spain Taiwan Thailand Turkey (Türkiye) United Kingdom Vietnam

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D7029C00001

Identifier Type: -

Identifier Source: org_study_id

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