Clinical Trial: The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

Study Status: Terminated
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 MESOTH

Brief Summary:

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.


Detailed Summary:

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

Sponsor: Azienda Ospedaliera Universitaria Senese

Current Primary Outcome: To determine the objective response [ Time Frame: Weeks 24 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease control rate (DCR) [ Time Frame: 1 year ]
    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
  • Safety [ Time Frame: 3 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 physycal examination findings are also included.
  • Progression free survival [ Time Frame: 1 years ]
    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


Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliera Universitaria Senese

Dates:
Date Received: July 31, 2012
Date Started: July 2012
Date Completion: January 2015
Last Updated: July 31, 2012
Last Verified: July 2012