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

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

First listed

Oct 21, 2025

Start date

Mar 19, 2026

Status verified

Jul 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

• Tomáš Janík, MD
  +49892000664
  [email protected]

Locations (3)

Find similar trials in Los Angeles, CA