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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT06921785

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tremelimumab (drug), Rilvegostomig (drug), Bevacizumab (drug), Atezolizumab (drug)
How long the study runs
Study runs about 58 months (dates as stated)
About the drug or intervention
Tremelimumab — drug: IV therapy · Rilvegostomig — drug: IV therapy · Bevacizumab — drug: IV therapy · Atezolizumab — drug: IV therapy
Patient visit burden
Not specified by the sponsor

In plain English

This is a phase 3 study looking at rilvegostomig combined with bevacizumab, with or without tremelimumab, as a first treatment for hepatocellular carcinoma (a type of liver cancer) that is advanced, has spread, or cannot be removed by surgery. It is funded by AstraZeneca.

Who can take part

  • Advanced or spread-out liver cancer (hepatocellular carcinoma) that cannot be removed by surgery
  • Able to carry out light activity or normal daily activities (performance status 0 or 1)
  • Liver cancer stage B (not suitable for local treatments) or stage C, according to the BCLC system
  • Good enough liver function (Child-Pugh class A)
  • At least one tumour that can be measured on a scan
  • People with active hepatitis B must have taken antiviral medicine for at least 14 days before joining, showing the virus is stable or responding
  • People with hepatitis C must have it well controlled; people with both hepatitis B and C cannot take part
  • Healthy enough organs and bone marrow, based on screening tests
  • No previous whole-body (systemic) treatment for this cancer
  • Cancer that cannot be cured by surgery or local treatments; if local treatment was given, it must have finished at least 28 days before the baseline scan

Who may not be able to

  • Any uncontrolled other illnesses
  • Autoimmune or inflammatory conditions needing long-term steroids or medicines that dampen the immune system
  • History of another primary cancer
  • Ongoing side effects from earlier cancer treatment (except hair loss) that have not got better
  • Fluid build-up in the tummy, chest, or around the heart needing drainage or similar treatment within the last 6 months
  • Primary immune deficiency or active infection
  • History of confusion caused by liver disease (hepatic encephalopathy)
  • Taking aspirin (325 mg a day or more) or certain blood-thinning medicines (dipyridamole, ticlopidine, clopidogrel, cilostazol) within the last 10 days
  • Full-dose blood thinners or clot-busting drugs for treatment purposes within the last 10 days
  • Significant bleeding disorders, inflamed blood vessels, or serious bleeding from the gut within the last 6 months
  • Untreated or not fully treated swollen veins (varices) in the gullet that have bled or are at high risk of bleeding
  • Certain rare liver cancer types (fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and liver cancer)
  • Cancer spread to the brain or spinal cord compression, even if treated and causing no symptoms
  • Previous treatment with anti-CTLA-4 or anti-TIGIT medicines
  • Radiotherapy within the last 28 days, or tummy or pelvic radiotherapy within the last 60 days (except palliative radiotherapy to bone within the last 7 days)

What taking part involves

  • • Rilvegostomig combined with bevacizumab
  • • The same combination with tremelimumab added
  • • Whether everyone gets both options, and for how long, is not stated — ask the trial team

Time commitment: Number of visits, how long the trial lasts, and how the drugs are given are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,220
Started
2025-05-06
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for hepatocellular carcinoma
  • • Phase3 - 1,220 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with hepatocellular carcinoma

Where?

  • • Cambridge - Research Site
  • • Leeds - Research Site
  • • London - Research Site
  • • London - Research Site
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Hepatocellular Carcinoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Treatment history

Treatments you must have had:

  • ✓ been completed ≥ 28 days

What the study is looking for

  • ✓that has grown locally or that has spread and/or unresectable HCC
  • ✓WHO/Fit enough for normal activity (ECOG 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

Who cannot take part

  • ✗Medical condition
  • ✗Any evidence of uncontrolled intercurrent diseases
  • ✗Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other...
  • ✗History of another primary cancer
  • ✗Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or...
See the full criteria
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

Where Is This Study? (6 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

NOT_YET_RECRUITING

Research Site

Leeds LS9 7TF, United Kingdom

Recruiting

Research Site

London NW3 2QG, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

London W12 0HS, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08