Condition: Unresectable or Metastatic Hepatocellular Carcinoma · Child-Pugh A Hepatocellular Carcinoma · Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound · Sponsor: CatalYm GmbH
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.
This description comes directly from the study's public registry record.
Tomáš Janík, MD · +49892000664 · regulatory-005@catalym.com
Always discuss trial participation with your own doctor first.
| USC Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| Peidmont Healthcare, Inc | Atlanta, Georgia, United States | Recruiting |
| OSF St. Francis Medical Center | Peoria, Illinois, United States | Recruiting |
| Hannover Medical School | Hanover, Lower Saxony, Germany | Recruiting |
| University Medical Center of Johannes Gutenberg University Mainz | Mainz, Rhineland-Palatinate, Germany | Recruiting |
| Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität | Frankfurt, Germany | Recruiting |
| Polyclinic S. Orsola-Malpighi | Bologna, Italy | Recruiting |
| Asst Grande Ospedale Metropolitano Niguarda | Milan, Italy | Recruiting |
| Ospedale S.Maria delle Croci | Ravenna, Italy | Recruiting |
| University Hospital Miguel Servet | Zaragoza, Aragon, Spain | Recruiting |
| Catalan Institute of Oncology, Hospital Duran i Reynals | L'Hospitalet de Llobregat, Barcelona, Spain | Recruiting |
| Hospital Clinic of Barcelona | Barcelona, Catalonia, Spain | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07219459