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

Sponsor
CatalYm GmbH
Study ID
NCT07219459
Phase
PHASE2
Status
Recruiting
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Conditions

  • Child-Pugh A Hepatocellular Carcinoma
  • Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound
  • Unresectable or Metastatic Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Visugromab RDE (recommended dose for expansion) — BIOLOGICAL
    Participants receive visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments
  • Nivolumab — BIOLOGICAL
    Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion
  • Lenvatinib — DRUG
    Participants receive Lenvatinib per os (PO) once daily according to body weight (\> 60kg: 12mg; \< 60kg: 8mg)
  • Placebo Saline Infusion — OTHER
    Saline (0.9%NaCl) intravenous (2x IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) for up to 35 treatments

Study Details

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.

Key Dates

Start date
Mar 19, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2031

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Visugromab (IV) + Nivolumab intravenous (IV) + Lenvatinib (PO)
  • Active Comparator: Arm B
    Lenvatinib (PO) + saline (double-placebo) intravenous (IV)

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: up to 36 months ]

Central Contacts