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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 - MK7902-012 (LEAP-012)

Studio Clinico

Patologia: Epatocarcinoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Has a diagnosis of 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 as long as their virus is well controlled
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function.

Criteri di esclusione: 

- Is currently a candidate for liver transplantation
- Has had gastric bleeding within the last 6 months
- Has ascites that is not controlled with medication
- 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.

Trattamento sperimentale: 

Pembrolizumab + Lenvatinib + TACE

Trattamento di controllo: 

TACE

Obiettivi primari dello studio: 

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

Centri partecipanti

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Telefono: 0630156018
Email: Vincenzina.mora@policlinicogemelli.it

 

Sud Italia e isole

A.O.U G Martino Messina
Via consolare Valeria 1 - 98124 Messina - ME

 

AORN Cardarelli
Via A Cardarelli 9 - 80131 napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-002345-37

Data di inserimento: 13.04.2021

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Riferimento: Prof. Antonio Gasbarrini

Telefono: 0630156018

Email: Vincenzina.mora@policlinicogemelli.it

Localita: Roma

 

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