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

Official record

Identifier

NCT07219459

Recruiting locations

countries

United StatesFranceGermanyItalySpainUnited Kingdom

Interventions studied

Visugromab RDE (recommended dose for expansion)NivolumabLenvatinibPlacebo Saline Infusion

Lead sponsor

CatalYm GmbH

Target enrolment

104 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Oct 21, 2025

Last updated on the registry

Sep 23, 2026

Age

18 Years – 100 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Main Inclusion Criteria:

* 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.
* Life expectancy of at least 3 months as assessed by the Investigator.
* ECOG performance status ≤1.
* Child-Pugh score of A6 or better.

Main Exclusion Criteria:

* 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.
* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction.
* Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
* Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors.
* Have one of the following cardiovascular risk factors: myocardial infarction, peri/myocarditis, or history of ischemic stroke in the past 3 months before planned treatment start, uncontrolled heart failure, uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex.
* An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start.
* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.
* Chronic systemic corticosteroid treatment for other reasons.
* Prior liver or other organ transplantation.

Indexed under

Liver Cancer