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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Tremelimumab is administered as endovenous infusion
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, Italy
RECRUITINGTo 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
Time frame: Weeks 24
Disease control rate (DCR)
DCR is the proportion of treated subjects that achieved confirmed CR or PR or stable disease (SD) The DCR is assessed using the modified RECIST Criteria for pleural mesothelioma umor assessment and the the immune-related response criteria
Time frame: 1 year
Safety
The assessment of safety includes serious and non-serious adverse events according to NCI-CTC criteria version 3.0. In addition, laboratory evaluation, abnormal vital signs and physycal examination findings are also included.
Time frame: 3 years
Progression free survival
Progression free survival is computed from the first day of study treatment to the day of documented progression according to the modified RECIST Criteria for pleural mesothelioma or death, whichever occurs first
Time frame: 1 years
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