At a glance
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A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma
In Brief
A Phase 2 clinical trial evaluating Tremelimumab and Placebo for Unresectable Pleural or Peritoneal Malignant Mesothelioma. Active but no longer recruiting, targeting 571 participants across 104 sites in 19 countries.
Detailed Summary
This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.
Study Details
Timeline
Interventions
Tremelimumab is to be administered as an IV solution, followed by observation.
Placebo is to be administered as an IV solution, followed by observation.