NCT04246177CompletedPhase 3
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular Carcinoma
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Aug 2025
Brief summary (registry, in English)
1.To compare pembrolizumab plus lenvatinib in combination with transarterial chemoembolization (TACE) versus placebo plus TACE with regard to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded, independent central review (BICR). 2.To compare pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to overall survival (OS).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 19 May 2023
- Start date
- 10 Jul 2020
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04246177
- EU CT number
- 2022-502116-36-00
- EudraCT number
- 2019-002345-37
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 200
- 24 sites in 9 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
- Is currently a candidate for liver transplantation
- Has ascites that is not controlled with medication
- Has received locoregional therapy to existing liver lesions
Other illness
- Has had gastric bleeding within the last 6 months
- Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
- Has a serious nonhealing wound, ulcer, or bone fracture
Who the study is looking for
- Has a diagnosis of hepatocellular carcinoma (HCC) confirmed by radiology, histology, or cytology
- Has HCC localized to the liver and not amenable to curative treatment
- Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
- Participants with Hepatitis B virus (HBV) are eligible
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| University Hospital Halle (Saale) Coordinator of this site? Confirm its status | Halle Saale | Germany | Completed |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Completed |
| Hospital La Croix Rousse Hcl Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Completed |
| Hopital Paul Brousse Coordinator of this site? Confirm its status | Villejuif Cedex | France | Completed |
| Zala Varmegyei Szent Rafael Korhaz Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Completed |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Completed |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Faenza | Italy | Completed |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.