Visugromab, NIV and LEN vs. LEN and double placebo in uHCC or mHCC post anti-PD-(L)1 failure
Research type
Research Study
Full 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 Anti-PD-(L)1 Compound (GDFATHER-HCC-01)
IRAS ID
1012639
Contact name
Mihaela David
Contact email
Sponsor organisation
CatalYm GmbH
Clinicaltrials.gov Identifier
Research summary
This clinical trial is studying the effectiveness and safety of a treatment using three drugs (visugromab, nivolumab, and lenvatinib) compared to a placebo and lenvatinib in patients with a type of liver cancer that has spread to other areas or can't be removed by surgery. Nivolumab is already available on the market as Opdivo® and it works with the immune system to help fight cancer. Lenvatinib is also already available on the market as Lenvima® and it stops cancer cells growing. Visugromab has not yet been approved by any regulatory bodies for use outside of this and other research trials. Visugromab works by restoring the immune system’s ability to target tumours and helps the immune system fight cancer. The trial has two parts:
Part 1: Involves 6 to 18 participants to find the dose of visugromab that will be used in Part 2.
Part 2: Involves 80 participants, comparing the new drug combination against a placebo and lenvatinib group to see which is more effective and safer.
In Part 2, patients are assigned randomly to either receive the visugromab, nivolumab, and lenvatinib combination or a placebo, alongside lenvatinib. This is a “blinded” trial meaning that neither the study Sponsor, the study doctor, the participant, nor the study staff will know which type of study drug treatment the participant is receiving. Visugromab, Nivolumab or Visugromab Placebo and Nivolumab Placebo are injected into a vein through a needle (intravenously (IV), lenvatinib is taken as a capsule (orally). Maximum participation duration in this trial is 4 years and will consist of a Screening Period (up to 28 days), Treatment Period (up to 2 years) and Safety Follow-up Period (up to 2 years). A total of 90 to 104 participants will join this trial. The trial is planned to run in 5 hospitals in the UK and a further XX hospitals around the world. Trial assessments will include electrocardiograms, blood and urine samples, physical examinations and a CT/MRI scans.REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0153
Date of REC Opinion
31 Dec 2025
REC opinion
Further Information Favourable Opinion