Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (NCT07219459)
A Phase 2b, Randomized, Blinded 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 Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- Peidmont Healthcare, Inc — Atlanta, Georgia
- OSF St. Francis Medical Center — Peoria, Illinois
- Hannover Medical School — Hanover, Lower Saxony
- University Medical Center of Johannes Gutenberg University Mainz — Mainz, Rhineland-Palatinate
- Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität — Frankfurt,
- Polyclinic S. Orsola-Malpighi — Bologna,
- Asst Grande Ospedale Metropolitano Niguarda — Milan,
- Ospedale S.Maria delle Croci — Ravenna,
- University Hospital Miguel Servet — Zaragoza, Aragon
- Catalan Institute of Oncology, Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona
- Hospital Clinic of Barcelona — Barcelona, Catalonia
- University Clinic of Navarra - Pamplona — Pamplona, Chartered Community of Navarra
- University Hospital Ramon y Cajal — Madrid, Madrid
📞 Contact the Study Coordinator
Phone: +49892000664
Email: regulatory-005@catalym.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Unresectable or Metastatic Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.