Study of Rilvegostomig with Bevacizumab and Tremelimumab as First-line Treatment for Patients with Advanced Liver Cancer

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What is this study about?

This study focuses on patients with advanced hepatocellular carcinoma, which is a type of liver cancer that has spread or cannot be removed by surgery. The research evaluates several medications including rilvegostomig, bevacizumab, and tremelimumab, which are drugs that work with the immune system to fight cancer cells. Another medication being studied is atezolizumab, which also helps the immune system target cancer cells.

The main purpose of this research is to determine if combining rilvegostomig with tremelimumab and bevacizumab is more effective than using atezolizumab with bevacizumab in treating advanced hepatocellular carcinoma. These medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

During the study, patients will be randomly assigned to different treatment groups. One group will receive rilvegostomig together with tremelimumab and bevacizumab, while another group will receive atezolizumab with bevacizumab. The study will monitor how patients respond to these treatments over time, particularly focusing on how long patients survive after starting treatment.

1 Initial treatment assignment

You will be randomly assigned to one of the treatment groups for advanced liver cancer (hepatocellular carcinoma)

Your treatment will be determined by random selection – either combination therapy with rilvegostomig, tremelimumab, and bevacizumab or atezolizumab with bevacizumab

2 Medical evaluation

Your liver function will be assessed to confirm you have Child-Pugh Score class A

Your overall physical condition will be evaluated using a standard scale (WHO/ECOG) to confirm your ability to perform daily activities

Your organ function and blood tests will be reviewed to ensure they are at appropriate levels

3 Treatment administration

You will receive your assigned medications through intravenous infusion

Regular imaging scans will be performed to measure how your tumor responds to treatment

Your overall health and any side effects will be monitored throughout the treatment period

4 Follow-up assessments

Regular medical examinations will track your progress

Imaging scans will be reviewed by independent specialists to assess how your tumor is responding to treatment

The duration of your response to treatment will be monitored and documented

5 Study completion

The study is expected to continue until March 2030

Your participation will help evaluate how effective these treatment combinations are for advanced liver cancer

Your overall survival and how long the treatment keeps the cancer under control will be key measures of the treatment’s effectiveness

Who Can Join the Study?

  • Must have advanced liver cancer (hepatocellular carcinoma) that has spread or cannot be surgically removed
  • Must be able to perform daily activities with minimal assistance (WHO/ECOG status of 0 or 1, where 0 means fully active and 1 means restricted in strenuous activities but able to carry out light work)
  • Must have liver cancer at BCLC stage B (intermediate stage not suitable for local treatment) or stage C (advanced stage), with good liver function (Child-Pugh class A)
  • Must have at least one tumor that can be measured on scans
  • Must not have both hepatitis B and hepatitis C infections
  • Must have adequate liver, kidney, and blood test results during the screening period
  • Must not have received any previous systemic treatment (medication that travels through the bloodstream) for intermediate or advanced liver cancer
  • Must not be eligible for curative surgery or local treatments. If previously received treatment, must wait:
    • At least 6 months after completing preventive therapy before having confirmed spread of cancer
    • At least 28 days after completing local treatment before baseline scan
  • Both men and women can participate
  • Must be an adult (18 years or older)

Who Cannot Join the Study?

  • Have received prior systemic therapy for advanced liver cancer (hepatocellular carcinoma)
  • Have active or untreated brain tumors or brain metastases (cancer that has spread to the brain)
  • Have active autoimmune disease requiring systemic treatment
  • Have uncontrolled high blood pressure
  • Have significant heart disease or had a heart attack within the past 6 months
  • Have active bleeding or high risk of bleeding
  • Have active hepatitis B or C infection
  • Are pregnant or breastfeeding
  • Have received organ transplant and are taking medications to prevent organ rejection
  • Have had major surgery within 28 days before starting the study
  • Are currently participating in another clinical trial
  • Have severe liver dysfunction
  • Have history of other cancers within the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Have known allergy or sensitivity to any of the study medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario De Navarra Pamplona Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Hospital Maastricht Maastricht The Netherlands
Oncopole Claudius Regaud Toulouse France
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Klinikum Dortmund gGmbH Dortmund Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Azienda Ospedaliera Di Perugia Perugia Italy
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Universitaire De Nice Nice France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie Cracow Poland
Sazzbors Kyjhoqjdawy Bzxrkkknd Fima Det Gkdmwqtxbu Mrftl Moers Germany
Uilhwnmqnv Moznyzo Cfufdg Hjtggsfghozbmoeup Hamburg Germany
Uxiqfwdsibopbrqplfjwe Euvjl Ana Essen Germany
Ukibucbcdzkq Mxqijfv Cveagol Gqfejmmue Groningen The Netherlands
Hcwjfinz Ukldhqijnalbo Mfpcgrb Db Vmidprjrrp Santander Spain
Gwibld Uifmftqoei Filennooq Frankfurt Germany
Knssrnpj dlo Uwgmygvmlgpf Mmgrsbae Atn Munich Germany
Ullkmjgwwezbox Cgdsppo Kfocvjvah Gdansk Poland
Asqrzxjcz Uiq Amsterdam The Netherlands
Etuyekg Ugslkgwnraap Mpdqqfz Ciobvbr Rywfdjbow (gejoiex Meg Rotterdam The Netherlands
Apjwwoz Utgdn Sghuqpjnd Lrkift Du Bgnebxp Bologna Italy
Npkfqwyc Izcomjbj Oghdlskxn Imp Myawy Ssitdlbdhdpgveorbwppgmdmtget Iysmxzzo Bqfabfmi Cracow Poland
Hefsnghi Vpmu dicuydbe Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.01.2026
Germany Germany
Recruiting
01.01.2026
Italy Italy
Recruiting
01.01.2026
Poland Poland
Not yet recruiting
01.01.2026
Spain Spain
Recruiting
01.01.2026
The Netherlands The Netherlands
Not yet recruiting
01.01.2026

Trial locations

Rilvegostomig is an investigational medication being studied for the treatment of advanced liver cancer (hepatocellular carcinoma). It belongs to a class of drugs that help the immune system fight cancer cells.

Bevacizumab is a medication that works by blocking the growth of blood vessels that feed tumors. It helps prevent the tumor from growing and spreading by cutting off its blood supply.

Tremelimumab is an immunotherapy medication that helps activate the body’s immune system to fight cancer cells. It works by blocking signals that prevent immune cells from attacking cancer.

Atezolizumab is an immunotherapy medication that helps the body’s immune system detect and fight cancer cells. It works by blocking a protein that cancer cells use to hide from immune cells.

Hepatocellular Carcinoma – A primary type of liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people who have chronic liver diseases, such as cirrhosis. It starts as small clusters of abnormal cells in the liver that gradually grow larger. As the cancer grows, it can spread within the liver and potentially to other parts of the body. The condition affects liver function and can cause symptoms like abdominal pain, unexplained weight loss, and yellowing of the skin.

Trial ID:
2024-518210-81-00
Protocol code:
D7029C00001
NCT ID:
NCT06921785
Trial Phase:
Therapeutic confirmatory (Phase III)

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