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Phase III Study of Rilvegostomig in Combination withBevacizumab with or without Tremelimumab as First-lineTreatment of Hepatocellular Carcinoma
EU CTIS ID: 2024-518210-81-00
What this study is testing
To demonstrate the efficacy of rilvegostomig in combination with tremelimumab and bevacizumab (Arm A) relative to atezolizumab and bevacizumab (Arm C) by assessment of OS in participants with advanced HCC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Any evidence of uncontrolled intercurrent diseases
- Bleeding or other risks. HCC related - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Bleeding or other risks. HCC related - Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
- Bleeding or other risks. HCC related - Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
- Bleeding or other risks. HCC related - 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
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
See the full eligibility 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. Participants who have received approved adjuvant therapy (including immune checkpoint inhibitor treatment) must have a minimum interval of 6 months between the completion of such therapy and the documented diagnosis of recurrent or metastatic disease. 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.
- Any evidence of uncontrolled intercurrent diseases
- Bleeding or other risks. HCC related - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Bleeding or other risks. HCC related - Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
- Bleeding or other risks. HCC related - Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
- Bleeding or other risks. HCC related - 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Canada
- India
- Korea, Republic of
- Vietnam
- Turkey
- Japan
- Brazil
- United States
- Australia
- United Kingdom
- China
- Hong Kong
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Canada; India; Korea, Republic of; Vietnam; Turkey and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.