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

Exclusion Criteria

• •At least one measurable target lesion
• •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.
• •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
• •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 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