NCT05822752Active, not recruitingPhase 2
Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC): Evaluation of the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab
A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab for locally advanced or Metastatic Hepatocellular Carcinoma patients who have progressed after an approved immune checkpoint inhibitor containing regimen in First-Line HCC
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Jul 2026
Brief summary (registry, in English)
To optimize livmoniplimab dose in combination with budigalimab and identify the recommended phase 3 dose in locally advanced or metastatic Child-Pugh A HCC patients who have progressed after an immune CPI-containing regimen in 1L HCC. To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by the rate of BOR of confirmed CR/PR determined by investigators.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 1 Mar 2024
- Lead sponsor
- Abbvie Deutschland GmbH & Co. KG
- Diseases
- Liver and biliary tract cancer
- EU CT number
- 2022-502948-13-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 63
- 21 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- No prior allogeneic stem cell or solid organ transplantation
- Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade ≤ 1 prior to study entry, except for alopecia.
Other illness
- No history of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%),
- Negative HIV test at screening due to potential safety concerns on those immune compromised patients.
Who the study is looking for
- Child-Pugh A ECOG PS 0-1 Received an immune checkpoint inhibitor in 1L HCC treatment regimen.No symptomatic, untreated, or actively progressing CNS metastases. Adequate hematologic and end-organ function Tissue biopsy at screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vall d'Hebron Institute of Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Hopital Saint Eloi Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Sanitaria Locale Napoli 1 Centro Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.