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
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective response
The objective response is defined as a confirmed complete response (CR), or partial response (PR) according to the modified RECIST Criteria for pleural mesothelioma and the immune-related (ir) Response Criteria
Weeks 24
No
Michele Maio, MD
Principal Investigator
Medical Oncology and Immunotherapy Unit, University Hospital of Siena, Italy
Italy: The Italian Medicines Agency
MESOT-TREM-2012
NCT01655888
July 2012
January 2015
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