NCT01655888

The Anti-CTLA-4 Monoclonal Antibody Tremelimumab 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. The MESOT-TREM-2012

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

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 description

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

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	Tremelimumab	Tremelimumab is administered as endovenous infusion

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-01-01
• Completion: 2015-01-01
• First posted: 2012-08-02
• Last updated: 2012-08-02

Locations

1 site across 1 country: Italy