PECATI

OFFICIAL TITLE: A MULTICENTRIC, OPEN-LABEL, SINGLE ARM PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF PEMBROLIZUMAB AND LENVATINIB IN PRE-TREATED THYMIC CARCINOMA PATIENTS. PECATI.

PROJECT DETAILS

PRIMARY OBJECTIVE

 

●       TO ASSESS THE EFFICACY OF PEMBROLIZUMAB AND LENVATINIB IN PRE-TREATED RELAPSED/RECURRENT B3-THYMOMA AND THYMIC CARCINOMA (TC) PATIENTS IN TERMS OF PROGRESSION FREE SURVIVAL (PFS) RATE AT 5 MONTHS.

SECUNDARY OBJETIVES

●       TO ASSESS THE EFFICACY OF PEMBROLIZUMAB AND LENVATINIB IN PRE-TREATED ADVANCED B3-THYMOMA AND TC PATIENTS IN TERMS OF PFS, RESPONSE RATE (RR), DISEASE CONTROL RATE (DCR) DURATION OF RESPONSE (DOR), TUMOR SHRINKAGE AND OVERALL SURVIVAL (OS).

●        TO ASSESS THE SAFETY AND TOXICITY PROFILE OF THE COMBINATION ACCORDING TO THE NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS VERSION 5.0 (CTCAE V.5.0).

PECATI AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

THYMIC

II

43

11

Spain, France, Italy

N

SITES

COUNTRY

STATUS

Start-up

PECATI SITES

SPAIN

Hospital Universitario La Paz

SPAIN

Complejo Hospitalario Universitario A Coruña

SPAIN

Hospital Universitario y Politécnico La Fe

SPAIN

Hospital Universitario Virgen del Rocio

FRANCE

Gustave Roussy

FRANCE

Hospital de Marseille

FRANCE

Hospital de Toulouse

FRANCE

Hospital Bordeaux

FRANCE

Instituto Curie

ITALY

Hospital de Turin