Spots Global Cancer Trial Database for The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

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Trial Identification

Brief Title: The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

Official Title: A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMAN ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA. The MESOT-TREM-2012

Study ID: NCT01655888

Conditions

Malignant Mesothelioma

Interventions

Tremelimumab

Study Description

Brief Summary: RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients. PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

Detailed Description: Primary endpoint: 1) To assess the rate of objective clinical complete response (CR) or partial response (PR) Secondary endpoints: 1. To define toxicity profile according to NCI CT-CAE V. 3 2. To assess the overall survival (OS) 3. To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) according to the modified Recist criteria 4. To assess the progression-free survival in treated patients according to modified Recist criteria 5. To evaluate qualitative and quantitative changes in cellular and humoral immune responses