Phase 2 Study of CVM-1118 Combined With Nivolumab for Adults With Unresectable Advanced Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the combination of CVM-1118, a new small molecule anti-cancer drug, with nivolumab, an immune checkpoint inhibitor, in people with unresectable advanced hepatocellular carcinoma HCC. This phase 2 study aims to further investigate the effectiveness of this combination treatment after safety was established in earlier studies. The trial focuses on HCC that cannot be removed by surgery and has progressed despite prior therapies, addressing a significant need for advanced liver cancer care. Participants receive nivolumab intravenously every two weeks at 240 mg, with an option to increase to 480 mg every four weeks from cycle 3 based on safety and tolerability. CVM-1118 is given orally twice daily starting at 200 mg, with a possible increase to 300 mg twice daily after safety assessment. Treatment cycles last 28 days and continue until disease progression, unacceptable side effects, or withdrawal of consent. During the study, participants undergo regular assessments including imaging scans to measure tumor response, laboratory tests, vital sign monitoring, and evaluation of side effects. The main outcome is the objective response rate measured 24 weeks after the last participant begins CVM-1118. Secondary outcomes include duration of response, progression-free and overall survival, safety assessments, and drug concentration levels. Follow-up continues for up to one year after the last dose to monitor long-term effects and safety.

CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma