The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
No effective standard treatment can improve significantly the prognosis of malignant mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from immunotherapeutic agents. Clinical studies examining CTLA-4 blockade are providing convincing evidences on the immunobiological effects and on the clinical activity of this new class of immunomodulating therapeutic agents, likely due to their ability to stimulate patients'immune system to more effectively attack tumor cells by blocking a negative regulatory signal. Tremelimumab is a fully human anti-CTLA-4 monoclonal antibody (mAb), developed as an IgG2 isotype to minimize complement activation and reduce the risk of cytokine storm. As a single agent, Tremelimumab can induce durable tumor regression in 7-10% of patients with advanced melanoma. Tremelimumab has been tested in several clinical trials as single-agent or in combination with other agents in different solid tumors. The evidences above unveil a strong immunologic potential of treatment with Tremelimumab also in MM patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Given IV
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, Italy
Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST)
The objective tumor response is defined as a confirmed complete response (CR) or partial response (PR) according to the modified RECIST criteria for pleural mesothelioma
Time frame: Weeks 24
Disease control rate
Disease control rate (DCR) is the proportion of treated subjects that achieved confirmed complete response, or partial response, or stable disease. The DCR is assessed using the modified RECIST criteria for pleural mesothelioma
Time frame: 1 year
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 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 physical examination findings are also included.
Time frame: 2 years
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