The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

Sponsor
Azienda Ospedaliera Universitaria Senese
Study ID
NCT01655888
Phase
PHASE2
Status
Unknown

Conditions

  • Malignant Mesothelioma

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    Tremelimumab is administered as endovenous infusion

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Jul 2012
Primary completion
Jan 31, 2014
Completion
Jan 31, 2015

Study Design

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

Arms

  • Experimental: single arm with Tremelimumab
    Tremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity

Primary Outcome Measure

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

Central Contacts

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