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NCT07219459 · ClinicalTrials.gov registry record · Phase 2
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
A Phase 2 study, sponsored by CatalYm.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT07219459 is a Phase 2 study that is actively recruiting participants, run by CatalYm. The registered enrollment target is 104 participants.
The verdict
NCT07219459, a Phase 2 study, is actively recruiting participants, sponsored by CatalYm.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
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 efficacy-evaluable participants are enrolled into each Treatment Arm.
Interventions
- BIOLOGICAL Nivolumab
- DRUG Lenvatinib
- BIOLOGICAL Visugromab RDE (recommended dose for expansion)
- OTHER Placebo Saline Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2026-03-19 |
| Est. Completion | 2031-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07219459
The ClinicalTrials.gov registry entry for NCT07219459 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CatalYm, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT07219459 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07219459 about?
NCT07219459 is a clinical study titled "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 fa...
What is the current status of trial NCT07219459?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2026-03-19. Estimated completion is 2031-09.
What interventions are being tested in trial NCT07219459?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Lenvatinib (DRUG), Visugromab RDE (recommended dose for expansion) (BIOLOGICAL), Placebo Saline Infusion (OTHER).
Who is sponsoring clinical trial NCT07219459?
This trial is sponsored by CatalYm, which has 4 total clinical trials registered on ClinicalTrials.gov.
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