Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure

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 effic

Trial Details

NCT ID
NCT07219459
Phase
PHASE2
Sponsor
CatalYm GmbH
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Visugromab RDE (recommended dose for expansion)
  • Nivolumab
  • Lenvatinib
  • Placebo Saline Infusion
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Peoria, Illinois, United States|40.69365,-89.58899
  • Hanover, Lower Saxony, Germany|52.37052,9.73322
  • Mainz, Rhineland-Palatinate, Germany|49.98185,8.28008

Key Eligibility 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 …
  • Age ≥ 18 years on the day of signing the informed consent.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Liver Cancer Trials on Trialify →