A Phase 2 Randomized Study to Evaluate the Optimized Dose Safety and Efficacy of Livmoniplimab in Combination with Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC - LIVIGNO-1

Brief description of study

This Phase 2, open-label, randomized study evaluates the optimal livmoniplimab dose and the safety and efficacy of livmoniplimab in combination with budigalimab in locally advanced or metastatic Child-Pugh A HCC patients who have progressed after an immune CPI-containing regimen in 1L HCC. There are 3 cohorts in this study. - Cohort 1 (control): Investigator's choice: Lenvatinib (8-12 mg, QD) or Sorafenib (800 mg [400 mg BID]) (N=40) - Cohort 2: Livmoniplimab (Dose A) + Budigalimab (N=40) - Cohort 3: Livmoniplimab (Dose B) + Budigalimab (N=40)


Clinical Study Identifier: s23-00133
ClinicalTrials.gov Identifier: NCT05822752


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