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

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-PughScore 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, ormetastatic HCC.

• Disease that is not amenable to curative surgical and/or locoregional therapies. Forparticipants who received locoregional therapy for HCC, locoregional therapy musthave 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 chronictreatment with steroids or other immunosuppressive treatment

• History of another primary malignancy

• Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, notyet improved to Grade ≤ 1 or baseline.

• Clinically meaningful ascites, pleural effusion, or pericardial effusion requiringnon-pharmacologic intervention to maintain symptomatic control within 6 months priorto 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, andcilostazol

• Current or recent (within 10 days prior to study treatment start) use of full-doseoral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposedto prophylactic) purposes is ineligible

Bleeding or other risks

HCC related

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

• Central nervous system metastases or spinal cord compression (including asymptomaticand adequately treated disease)

• Prior treatment with anti-CTLA-4 and/or anti-TIGIT.

• Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days priorto initiation of study treatment, except palliative radiotherapy to bone lesionswithin 7 days prior to initiation of study treatment