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
No effective standard treatment can improve significantly the prognosis of malignant
mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Michele Maio, MD
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Italy: The Italian Medicines Agency