Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
Visugromab RDE (recommended dose for expansion): 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: 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: Participants receive Lenvatinib per os (PO) once daily according to body weight (\> 60kg: 12mg; \< 60kg: 8mg)
Placebo Saline Infusion: 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 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.
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) — up to 36 months
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.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| UC Irvine Health. Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| Peidmont Healthcare, Inc | Atlanta | Georgia | Recruiting |
| OSF St. Francis Medical Center | Peoria | Illinois | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque | Pessac | France | Recruiting |
| Poitiers University Hospital Center - Miletrie Hospital | Poitiers | France | Recruiting |
| Gustave Roussy | Villejuif | France | Recruiting |
| Hannover Medical School | Hanover | Lower Saxony | Recruiting |
| University Medical Center of Johannes Gutenberg University Mainz | Mainz | Rhineland-Palatinate | Recruiting |
| Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität | Frankfurt | Germany | Recruiting |
| Polyclinic S. Orsola-Malpighi | Bologna | Italy | Recruiting |
| Ospedale San Raffale, IRCCS | Milan | Italy | Recruiting |
| Asst Grande Ospedale Metropolitano Niguarda | Milan | Italy | Recruiting |
| Ospedale S.Maria delle Croci | Ravenna | Italy | Recruiting |
| University Hospital Miguel Servet | Zaragoza | Aragon | Recruiting |
| Catalan Institute of Oncology, Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| Hospital Clinic of Barcelona | Barcelona | Catalonia | Recruiting |
| University Clinic of Navarra - Pamplona | Pamplona | Chartered Community of Navarra | Recruiting |
| University Hospital Ramon y Cajal | Madrid | Madrid | Recruiting |
| Western General Hospital | Edinburgh | United Kingdom | Recruiting |
| King's College Hospital | London | United Kingdom | Recruiting |
More CatalYm GmbH trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07219459 on ClinicalTrials.gov ↗ ← All trials in Italy