A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC)

Launched by ABBVIE · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two investigational drugs, livmoniplimab and budigalimab, to see how well they work together in treating patients with hepatocellular carcinoma (HCC), a serious type of liver cancer. The trial consists of two stages. In the first stage, participants will receive either different doses of livmoniplimab combined with budigalimab, or other approved treatments, to determine the best dose and monitor any side effects. In the second stage, participants will continue with the optimized dose of livmoniplimab and budigalimab or receive a different treatment. The study aims to enroll about 660 adult participants from various locations around the world.

To be eligible for this trial, participants should have advanced HCC that cannot be surgically removed and meet certain health criteria, such as having a specific liver function score. Participants can expect to attend regular visits at a hospital or clinic, where they will undergo various tests and assessments to monitor their health and the effects of the treatment. While this trial may require more frequent visits and tests than standard treatments, it offers a chance to access new therapies that could be beneficial for their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria for participants with cirrhosis.
• • Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
• • Child-Pugh A or B7 classification (i.e., total Child-Pugh score of 5, 6, or 7).
• • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Exclusion Criteria:
• • Prior systemic therapy for HCC.
• • Symptomatic, untreated, or actively progressing CNS metastases.
• • History of malignancy other than HCC.