A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

Sponsor
Azienda Ospedaliera Universitaria Senese
Study ID
NCT01649024
Phase
PHASE2
Status
Unknown

Conditions

  • Malignant Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
May 31, 2009
Status verified
Jul 2012
Primary completion
Jun 30, 2012
Completion
Jun 30, 2013

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm of Tremelimumab
    Tremelimumab is administered at 15 mg/kg on day 1 every 12 weeks for 4 doses

Primary Outcome Measure

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

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