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

Launched by ASTRAZENECA · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for advanced liver cancer, known as hepatocellular carcinoma (HCC). The researchers want to see if a combination of rilvegostomig and bevacizumab, with or without another drug called tremelimumab, works better than a different treatment that includes atezolizumab and bevacizumab. The goal is to find out which treatment is safer and more effective for patients whose liver cancer cannot be treated with surgery or other local therapies.

To participate in the trial, individuals must have locally advanced or metastatic liver cancer that is not suitable for surgery. They should be in good overall health, with a specific performance status indicating they can carry out daily activities. Participants should also have measurable cancer lesions and must not have received previous systemic treatments for their liver cancer. If someone joins the study, they can expect to receive a new treatment combination and be monitored closely for any effects. It’s important to note that this trial is not yet recruiting participants, so there will be more information available when it starts.

Gender

ALL

Eligibility criteria

• 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-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.
• Exclusion Criteria:
• • 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