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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: Recruiting Phase 2 study, sponsored by CatalYm.
NCT07219459 is a Phase 2 study that is actively recruiting participants, run by CatalYm. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Investigator assessed Progression-free survival (PFS) time from randomization (during Safety Run-In: initiation of treatment) to first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first.
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 |
What NCT07219459 shows while recruiting
NCT07219459 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT07219459 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07219459's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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