A Phase 23 Randomized Study to Evaluate Dose Optimization, Safety, and Efficacy of Livmoniplimab Combined With Budigalimab in Adults With Advanced or Metastatic Hepatocellular Carcinoma

What this Trial Is About

Hepatocellular carcinoma HCC is a common and serious cancer often diagnosed at an advanced stage that cannot be surgically removed or has spread to other parts of the body. Researchers are evaluating the optimal dose, side effects, and effectiveness of the investigational drug livmoniplimab when combined with budigalimab for adults with advanced or metastatic HCC who have not received prior systemic treatment. This phase 23 randomized study aims to improve treatment options for this challenging condition. The study has two stages with different treatment groups. In Stage 1, participants are randomly assigned to one of three groups two groups receive different doses of livmoniplimab combined with budigalimab every three weeks, while the control group receives either atezolizumab with bevacizumab every three weeks or tremelimumab with durvalumab every four weeks. In Stage 2, participants are randomly assigned to receive either the optimized dose of livmoniplimab with budigalimab every three weeks or tremelimumab with durvalumab every four weeks. Treatment continues until the disease progresses or other discontinuation criteria are met. The study is expected to last about 56 months. Participants will have regular visits for treatments and monitoring at hospitals or clinics throughout the study. Assessments include medical exams, blood tests, questionnaires about quality of life, and scans to measure tumor response and disease progression. Researchers will evaluate outcomes such as overall survival, progression-free survival, response duration, and treatment safety. Participants may experience a higher treatment burden than standard care due to frequent visits and tests.

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)