RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: CatalYm GmbH • ClinicalTrials.gov ID: NCT07219459

Registry updated: 2026-09-23

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Description

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.

Interventions

Visugromab RDE (recommended dose for expansion) (Biological)
Participants receive visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments
Nivolumab (Biological)
Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion
Lenvatinib (Drug)
Participants receive Lenvatinib per os (PO) once daily according to body weight (\> 60kg: 12mg; \< 60kg: 8mg)
Placebo Saline Infusion (Other)
Saline (0.9%NaCl) intravenous (2x IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) for up to 35 treatments

Eligibility criteria

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.

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma Child-Pugh A Hepatocellular Carcinoma Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound

Locations

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
UC Irvine Health. Chao Family Comprehensive Cancer Center — Orange, California, United States
Peidmont Healthcare, Inc — Atlanta, Georgia, United States
OSF St. Francis Medical Center — Peoria, Illinois, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque — Pessac, France
Poitiers University Hospital Center - Miletrie Hospital — Poitiers, France
Gustave Roussy — Villejuif, France
Hannover Medical School — Hanover, Lower Saxony, Germany
University Medical Center of Johannes Gutenberg University Mainz — Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität — Frankfurt, Germany
Polyclinic S. Orsola-Malpighi — Bologna, Italy
Ospedale San Raffale, IRCCS — Milan, Italy
Asst Grande Ospedale Metropolitano Niguarda — Milan, Italy
Ospedale S.Maria delle Croci — Ravenna, Italy
University Hospital Miguel Servet — Zaragoza, Aragon, Spain
Catalan Institute of Oncology, Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic of Barcelona — Barcelona, Catalonia, Spain
University Clinic of Navarra - Pamplona — Pamplona, Chartered Community of Navarra, Spain
University Hospital Ramon y Cajal — Madrid, Madrid, Spain
Western General Hospital — Edinburgh, United Kingdom
King's College Hospital — London, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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