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.
Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach.
Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment.
Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period.
Age ≥ 18 years on the day of signing the informed consent.
Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.
More than 1 line of prior systemic treatment for unresectable or metastatic HCC.
Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP.
Expected to require any other form of antineoplastic therapy during the trial.