ClinicaliQ Trial Snapshot
- Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure — Recruiting • Phase II • Oncology • NCT07219459.
- Treatment being tested: Triple combination of visugromab (anti-VEGF-C monoclonal antibody), nivolumab (anti-PD-1), and lenvatinib (tyrosine kinase inhibitor) versus lenvatinib monotherapy plus placebo in treatment-resistant hepatocellular carcinoma.
- Patient eligibility: Adults with unresectable or metastatic HCC who have progressed on prior anti-PD-(L)1 therapy, with preserved liver function (Child-Pugh Class A), demonstrating an immunotherapy-refractory population requiring salvage treatment options.
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What This Trial Is Studying
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…
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.