A Phase 2, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma.
Primary objective is to compare the overall survival between the 2 treatment arms (Tremelimumab and placebo) in subjects with unresectable malignant mesothelioma. The safety, tolerability, immunogenicity and pharmacokinetics of Tremelimumab will be evaluated. Biomarkers and their association with Tremlimumab treatment and clinical outcome will be examined.
Adult subjects with histologically and/or cytologically confirmed unresectable pleural or peritoneal malignant mesothelioma . Received no more than 2 prior systemic chemotherapy regimens for advanced disease including first-line Pemetrexed combination with a platinum agent. ECOG PS 0-1. Adequate renal, hepatic and bone marrow function. Brain metastases allowed if treated and stable. No inflammatory bowel disease, diarrhea, immunosuppressive medications or disease.
Patients will be randomized to receive either Tremelimumab or placebo IV every 4 weeks for six doses (week 25). Treatment will then be every 12 weeks until disease progression, unacceptable toxicity, or other reason to discontinue treatment.
07/24/2014 04:10 AM