PECATI

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.

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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.

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SECUNDARY OBJETIVES

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●       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).

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PECATI AT CLINICALTRIALS.GOV