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Taking people in United KingdomPhase 2

Tests visugromab with nivolumab and lenvatinib in advanced liver cancer after prior immunotherapy

Tests visugromab with nivolumab and lenvatinib in adults with advanced liver cancer.

Key facts

Who runs it
CatalYm GmbH
Where
Edinburgh, London, and Manchester, United KingdomSee the 3 sitesAlso in 6 other countries, 34 sites
Trial code
Registry title
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Status
Recruiting
Phase
Phase 2
People taking part
104 people, planned
Started
19 Mar 2026
Expected to end
Sept 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Visugromab RDE (recommended dose for expansion)
  • Nivolumab
  • Lenvatinib
  • Placebo Saline Infusion
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver cancer (hepatocellular carcinoma) that cannot be removed by surgery or has spread, whose first treatment with an anti PD-(L)1 drug stopped working.

Age
18 Years to 100 Years
Sex
All sexes can join.
Disease stage
Liver cancer confirmed under the microscope, not removable by surgery or spread, with disease that can be measured on scans. Liver function must be Child-Pugh A6 or better.
Earlier treatment
Must have had exactly one earlier drug treatment for this cancer that included an approved anti PD-(L)1 drug. It must have been taken for at least 12 weeks with no documented progression in that time.

Main reasons for not taking part

  • Fibrolamellar or sarcomatoid liver cancer, or mixed cholangiocarcinoma
  • More than 1 earlier drug treatment for this cancer
  • Active cancer spread to the brain or central nervous system
  • Active autoimmune disease that needed systemic treatment in the past 3 months
  • Earlier liver or other organ transplant

The registry criteria, word for word

Show all 20 criteriaShow less

Other 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in United Kingdom

Also in 6 other countries, 34 sites

  • Western General HospitalEdinburgh, United KingdomContact: Mary CarsonTaking people
  • King's College HospitalLondon, United KingdomContact: Debashis Sarker, DrTaking people
  • The Christie NHS Foundation TrustManchester, United KingdomContact: Richard Hubner, DrTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm ATreatment being tested

    Visugromab (IV) + Nivolumab intravenous (IV) + Lenvatinib (PO)

    Treatment: Visugromab RDE (recommended dose for expansion), Nivolumab, and Lenvatinib

  • Arm BExisting treatment, for comparison

    Lenvatinib (PO) + saline (double-placebo) intravenous (IV)

    Treatment: Lenvatinib and Placebo Saline Infusion

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2b, Randomized, Blinded 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 Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)
Plain-language title
Tests visugromab with nivolumab and lenvatinib in advanced liver cancer after prior immunotherapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07219459, who can take part
Record updated
10 November 2026