Back to search results

Visugromab, Nivolumab, and Lenvatinib for Liver Cancer

This study is testing a combination of three medicines – visugromab, nivolumab, and lenvatinib – for people with advanced liver cancer (hepatocellular carcinoma or HCC) that has spread or cannot be removed by surgery. This is for patients whose cancer has not responded to a previous treatment that included an anti-PD-(L)1 drug. The study will compare this three-drug combination to lenvatinib plus a placebo (an inactive substance). We want to see if the combination treatment can stop the cancer from growing for longer. You might be able to join if you are 18 to 100 years old, have measurable liver cancer that has progressed after a prior anti-PD-(L)1 treatment, and have good liver function. This study is currently recruiting participants.

Study design
This is a Phase 2b, randomized, and blinded study involving 104 participants. This means participants will be assigned by chance to one of two treatment groups, and neither you nor your doctors will know which treatment you are receiving.
What's involved
Participants will receive treatments intravenously (into a vein) or by mouth every 21 days for up to 35 cycles. The study will monitor how long it takes for the cancer to grow or spread, for up to 36 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival (how long the cancer is controlled) for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219459

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
CatalYm GmbH
~104 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Visugromab RDE (recommended dose for expansion)NivolumabLenvatinibPlacebo Saline Infusion

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over up to 36 months

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

Explore related trials

Hepatocellular Carcinoma

NCT07219459

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Italystudy coordinator listed

    Recruiting

  • Catalan Institute of Oncology, Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, Spainstudy coordinator listed

    Recruiting

  • Hannover Medical School

    Hanover, Lower Saxony, Germanystudy coordinator listed

    Recruiting

  • Hospital Clinic of Barcelona

    Barcelona, Catalonia, Spainstudy coordinator listed

    Recruiting

  • OSF St. Francis Medical Center

    Peoria, Illinoisstudy coordinator listed

    Recruiting

  • Ospedale S.Maria delle Croci

    Ravenna, Italystudy coordinator listed

    Recruiting

  • Peidmont Healthcare, Inc

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Polyclinic S. Orsola-Malpighi

    Bologna, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Tomáš Janík, MD
[email protected]
+49892000664 · ext. 31
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Progression-free survival (PFS)up to 36 months

    Investigator assessed Progression-free survival (PFS) time from randomization (during Safety Run-In: initiation of treatment) to first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first.