Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Unresectable or Metastatic Hepatocellular Carcinoma, Child-Pugh A Hepatocellular Carcinoma, Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound
In brief
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 facts
- Study ID
- NCT07219459
- Run by
- CatalYm GmbH
- People needed
- 104
- Starts
- 2026-03-19
- Expected to finish
- 2031-09-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Peidmont Healthcare, Inc — Atlanta, Georgia, United States (enrolling)
- OSF St. Francis Medical Center — Peoria, Illinois, United States (enrolling)
- Hannover Medical School — Hanover, Lower Saxony, Germany (enrolling)
- University Medical Center of Johannes Gutenberg University Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)
- Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität — Frankfurt, Germany (enrolling)
- Polyclinic S. Orsola-Malpighi — Bologna, Italy (enrolling)
- Asst Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
- Ospedale S.Maria delle Croci — Ravenna, Italy (enrolling)
- University Hospital Miguel Servet — Zaragoza, Aragon, Spain (enrolling)
- Catalan Institute of Oncology, Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
- Hospital Clinic of Barcelona — Barcelona, Catalonia, Spain (enrolling)
- University Clinic of Navarra - Pamplona — Pamplona, Chartered Community of Navarra, Spain (enrolling)
- University Hospital Ramon y Cajal — Madrid, Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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