Malignant Mesothelioma Clinical Trial
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
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.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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