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.

CLINICAL TRIAL DETAILS

THYMIC EPITHELIAL TUMORS (TETS) ARE RARE THORACIC TUMORS CONSISTING ON NEOPLASTIC PROLIFERATIONS OF THYMIC EPITHELIAL CELLS HARBORING INCREASING CLINICAL AGGRESSIVENESS FROM TYPE A, AB, B1, B2, AND B3 TETS TO THYMIC CARCINOMAS, ACCORDING TO THE WHO HISTOLOGIC GRADE CLASSIFICATION. AUTOIMMUNE DISORDERS MAY ACCOMPANY TETS. FOR ADVANCED TET, FIRST-LINE PLATINUM-BASED CHEMOTHERAPY IS AN ACCEPTED STANDARD OF CARE. WHEN THE TUMOR STOPS RESPONDING TO THIS INITIAL THERAPY, THOUGH, THE BEST THERAPY FOR SECOND-LINE TREATMENT IS NOT YET DEFINED, ALTHOUGH DIFFERENT STRATEGIES HAVE BEEN TESTED. THEREFORE, IDENTIFICATION OF NEW THERAPEUTIC STRATEGIES AFTER THESE TUMORS STOP RESPONDING TO FRONTLINE PLATINUM-BASED THERAPY IS STRONGLY NEEDED.

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

N

SITES

COUNTRY

STATUS

THYMIC

II

43

11

Spain, France, Italy

Start-up

PECATI SITES

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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