Phase III Study of Rilvegostomig and Bevacizumab, With or Without Tremelimumab, for First-line Treatment of Liver Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06921785
This clinical trial is testing a new combination of drugs, including rilvegostomig and bevacizumab, with or without tremelimumab, to see if they are effective and safe as a first treatment for advanced liver cancer that cannot be treated with surgery or local therapies.
Patient Parameters
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Program Overview
The study aims to find out if a new combination of drugs, rilvegostomig and bevacizumab, with or without tremelimumab, can effectively treat advanced liver cancer (HCC) that cannot be removed by surgery or treated with local therapies. The trial is divided into two parts: an initial safety phase to check the safety of the drug combination, followed by a randomized phase to compare the new treatment with the current standard treatment of atezolizumab and bevacizumab.
Description
This study is designed to evaluate how well the combination of rilvegostomig and bevacizumab, with or without tremelimumab, works as a first treatment for people with advanced liver cancer (HCC). The study will first test the safety of these drugs together in a small group of participants. After confirming safety, the study will compare the effectiveness of this new treatment against the standard treatment of atezolizumab and bevacizumab in a larger group of participants. The goal is to see if the new combination can better control the cancer and improve patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Have advanced liver cancer (HCC) that cannot be removed by surgery or treated with local therapies.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a specific stage of liver cancer (BCLC stage B or C) and a Child-Pugh Score class A.
- Have at least one tumor that can be measured by scans.
- Have good organ and bone marrow function as shown by tests during screening.
- Have not received any previous systemic treatment for advanced liver cancer.
- If previously treated with local therapies, these must have been completed at least 28 days before starting the study.
Exclusion Criteria
- Have uncontrolled medical conditions or active autoimmune or inflammatory disorders requiring long-term steroid or immunosuppressive treatment.
- Have a history of another type of cancer.
- Have ongoing side effects from previous cancer treatments, except for hair loss.
- Have significant fluid buildup in the abdomen, chest, or around the heart that needs treatment.
- Have a history of liver-related brain issues or active infections.
- Are currently using high doses of aspirin or certain blood-thinning medications.
- Have specific types of liver cancer or cancer that has spread to the brain or spinal cord.
- Have had certain cancer treatments, like radiotherapy, within a specified time before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 94304 | Palo Alto | California |
| Research Site | 30322 | Atlanta | Georgia |
| Research Site | 49503 | Grand Rapids | Michigan |
| Research Site | 08901 | New Brunswick | New Jersey |
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