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RecruitingUnresectable or Metastatic Hepatocellular CarcinomaChild-Pugh A Hepatocellular CarcinomaFailure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound

Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure

Eligible age

18–100 yrs

Accepts

All genders

Locations

3 states

Healthy volunteers

No

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About this study

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.

Sponsor: CatalYm GmbH

Where it's recruiting

California

Los Angeles

Georgia

Atlanta

Illinois

Peoria

Source: ClinicalTrials.gov · NCT07219459 · last updated 2026-07-21

Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Le · TrialPath