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

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. 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
• * 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
• * 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