Actively Recruiting
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Led by CatalYm GmbH · Updated on 2026-04-27
104
Participants Needed
2
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed unresectable or metastatic hepatocellular carcinoma not suitable for curative treatment
- Measurable disease per RECIST v1.1 based on local radiologist assessment
- Failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti-PD-(L)1 checkpoint inhibitor, with at least 12 weeks exposure without documented progression
- Age 18 years or older at consent
- Life expectancy of at least 3 months as assessed by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh score of A6 or better
You will not qualify if you...
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma
- More than one prior line of systemic treatment for unresectable or metastatic HCC
- Received or completed any palliative radiotherapy for symptoms within 28 days before first dose of investigational medicinal product
- Expected to need other antineoplastic therapy during the trial
- Active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction
- History of prior malignancy unless treated with curative intent and no recurrence for 5 years
- Clinically active central nervous system involvement by HCC or other tumors
- Cardiovascular risk factors including recent myocardial infarction, myocarditis, peri/myocarditis, ischemic stroke within 3 months, uncontrolled heart failure or ventricular arrhythmia, or QTc interval ≥470 ms
- Active autoimmune disease requiring systemic treatment in past 3 months
- Use of metformin or metformin-containing antidiabetics in type II diabetes
- Chronic systemic corticosteroid treatment for other reasons
- Prior liver or other organ transplantation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität
Frankfurt, Germany, 60590
Actively Recruiting
2
Asst Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
Research Team
F
Felix Lichtenegger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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