Recruiting

Phase 3

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

Sponsor:

AstraZeneca

Code:

NCT06921785

Conditions

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tremelimumab

Rilvegostomig

Bevacizumab

Atezolizumab

Study Details

Brief summary:

This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy

Conditions

Hepatocellular Carcinoma

Study ID

NCT06921785

Start date

May 6, 2025

Status verified date

Aug, 2026

Completion date

Mar 15, 2030

Anticipated

Primary completion date

Mar 15, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Tremelimumab , rilvegostomig and bevacizumab

experimental: Arm B

Rilvegostomig, and bevacizumab

active comparator: Arm C

Atezolizumab, and bevacizumab

Interventions

Tremelimumab

IV therapy

Rilvegostomig

IV therapy

Bevacizumab

IV therapy

Atezolizumab

IV therapy

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 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

Recruiting

Tucson, Arizona, United States, 85719

Research Site

Recruiting

Los Angeles, California, United States, 90095

Research Site

Recruiting

Palo Alto, California, United States, 94304

Research Site

Recruiting

New Haven, Connecticut, United States, 06520

Research Site

Recruiting

Newark, Delaware, United States, 19713

Research Site

Recruiting

Jacksonville, Florida, United States, 32224

Research Site

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Atlanta, Georgia, United States, 30318

Research Site

Recruiting

Chicago, Illinois, United States, 60637

Research Site

Recruiting

Detroit, Michigan, United States, 48202

Research Site

Recruiting

Grand Rapids, Michigan, United States, 49503

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

New Brunswick, New Jersey, United States, 08901

Research Site

Recruiting

New York, New York, United States, 10029

Research Site

Recruiting

New York, New York, United States, 10032

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Research Site

Recruiting

Amarillo, Texas, United States, 79124

Research Site

Recruiting

Austin, Texas, United States, 78705

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

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San Antonio, Texas, United States, 78240

Research Site

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Tyler, Texas, United States, 75702

Research Site

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Arlington, Virginia, United States, 22201

Research Site

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Salem, Virginia, United States, 24153

Research Site

Recruiting

Seattle, Washington, United States, 98101

Research Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

Research Site

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Research Site

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Research Site

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Research Site

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Research Site

Recruiting

Québec, Quebec, Canada, G1J 1Z4

More Information

Sponsor

AstraZeneca

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-03.