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

Recruiting Phase 2 Interventional Study
Unresectable or Metastatic Hepatocellular Carcinoma Child-Pugh A Hepatocellular Carcinoma Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
104 (estimated)
Sponsor
CatalYm GmbH · Industry
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About This Trial
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-r…
Trial Locations
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Eligibility Criteria
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 sys…
Contacts

Tomáš Janík, MD

+49892000664

regulatory-005@catalym.com

CONTACT