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Clinical Trials in the UK / NCT06921785
Recruiting Phase 3

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

NCT06921785 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-05-06
Last updated
2026-09-03

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

TremelimumabRilvegostomigBevacizumabAtezolizumab

Tremelimumab: IV therapy

Rilvegostomig: IV therapy

Bevacizumab: IV therapy

Atezolizumab: IV therapy

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (219)

FacilityCityRegionStatus
Research Site Phoenix Arizona Recruiting
Research Site Tucson Arizona Recruiting
Research Site Los Angeles California Recruiting
Research Site Palo Alto California Recruiting
Research Site New Haven Connecticut Recruiting
Research Site Newark Delaware Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Orlando Florida Not Yet Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Atlanta Georgia Withdrawn
Research Site Honolulu Hawaii Withdrawn
Research Site Chicago Illinois Recruiting
Research Site Indianapolis Indiana Not Yet Recruiting
Research Site Shreveport Louisiana Not Yet Recruiting
Research Site Detroit Michigan Recruiting
Research Site Grand Rapids Michigan Recruiting
Research Site Rochester Minnesota Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site New Brunswick New Jersey Recruiting
Research Site New York New York Recruiting
Research Site New York New York Recruiting
Research Site New York New York Not Yet Recruiting
Research Site Cleveland Ohio Withdrawn
Research Site Oklahoma City Oklahoma Not Yet Recruiting
Research Site Philadelphia Pennsylvania Not Yet Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Research Site Amarillo Texas Recruiting
Research Site Austin Texas Recruiting
Research Site Dallas Texas Withdrawn
Research Site Houston Texas Recruiting
Research Site San Antonio Texas Recruiting
Research Site Tyler Texas Recruiting
Research Site Arlington Virginia Recruiting
Research Site Salem Virginia Recruiting
Research Site Seattle Washington Recruiting
Research Site Milwaukee Wisconsin Recruiting
Research Site Auchenflower Australia Recruiting
Research Site Camperdown Australia Recruiting
Research Site Clayton Australia Not Yet Recruiting
Research Site Heidelberg Australia Recruiting

+ 179 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Tecentriq (atezolizumab) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921785 on ClinicalTrials.gov ↗ ← All trials in the UK