Clinical Trial: A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Mesothe

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

Detailed Summary:

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.


Sponsor: Azienda Ospedaliera Universitaria Senese

Current Primary Outcome: Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) [ Time Frame: Weeks 24 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease control rate [ Time Frame: 1 year ]

    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

  • Progression free survival [ Time Frame: 1 year ]
    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
  • Safety [ Time Frame: 2 years ]
    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.


Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliera Universitaria Senese

Dates:
Date Received: July 18, 2012
Date Started: May 2009
Date Completion: June 2013
Last Updated: July 20, 2012
Last Verified: July 2012