Status:
NOT_YET_RECRUITING
Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Lead Sponsor:
CatalYm GmbH
Conditions:
Unresectable or Metastatic Hepatocellular Carcinoma
Failure of First-Line Treatment That Included an Anti PD-(L)1 Compound
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and a TKI compared to double placebo and a TKI in participants ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07219459
Start Date
February 1 2026
End Date
September 1 2031
Last Update
October 21 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114