This is a Phase 2b, randomly assigned, blinded clinical trial investigating the how well it works and safety of visugromab in combination with nivolumab and Lenvatinib compared to double dummy treatment (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-randomly assigned Safety-run-in part (Part 1) and the subsequent randomly assigned part (Part 2) with 2 treatment arms (A and B).
Official registry: https://clinicaltrials.gov/study/NCT07219459 · CatalYm GmbH · enrollment listed as 104
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Visugromab RDE (recommended dose for expansion), Nivolumab, or Lenvatinib. The registry lists allocation as randomized. This is a Phase 2b, randomly assigned, blinded clinical trial investigating the how well it works and safety of visugromab in combination with nivolumab and Lenvatinib compared to double dummy treatment (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.
They plan to enroll about 104 people at 29 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
A Phase 2b, Randomized, Blinded 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 Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)
Interventions: Visugromab RDE (recommended dose for expansion), Nivolumab, Lenvatinib, Placebo Saline Infusion
Primary outcome (registry wording): Progression-free survival (PFS)
Tomáš Janík, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 22 sites outside the US on the same record
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
NCT00451022 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs.
NCT02417740 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary