NCT01649024

A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Senese · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.

Detailed description

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.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	Tremelimumab	Given IV

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-06-01
• Completion: 2013-06-01
• First posted: 2012-07-25
• Last updated: 2012-07-25

Locations

1 site across 1 country: Italy