Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Start Date
3/19/2026
Completion Date
9/1/2031
Summary
This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
Visugromab RDE (recommended dose for expansion)
Nivolumab
Lenvatinib
Placebo Saline Infusion
Conditions
Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Peidmont Healthcare, Inc
Atlanta, Georgia 30309
United States
OSF St. Francis Medical Center
Peoria, Illinois 61637
United States
Hannover Medical School
Hanover, Lower Saxony 30625
Germany
University Medical Center of Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate 55131
Germany
Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität
Frankfurt, 60590
Germany
Polyclinic S. Orsola-Malpighi
Bologna, 40138
Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
University Hospital Miguel Servet
Zaragoza, Aragon 50009
Spain
Hospital Clinic of Barcelona
Barcelona, Catalonia 08036
Spain
University Clinic of Navarra - Pamplona
Pamplona, Chartered Community of Navarra 31008
Spain
University Hospital Ramon y Cajal
Madrid, Madrid 28034
Spain