Study identifier:D4880C00003
ClinicalTrials.gov identifier:NCT01843374
EudraCT identifier:2012-003524-21
CTIS identifier:2024-511841-20-00
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
Unresectable Pleural or Peritoneal Malignant Mesothelioma
Phase 2
No
Tremelimumab, Placebo
All
571
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Feb 2025 by MedImmune, LLC
MedImmune, LLC
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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.
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. Randomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. 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.
Location
Location
Tampa, FL, United States, 33612
Location
Peoria, IL, United States, 61615
Location
Los Angeles, CA, United States, 90025
Location
Chicago, IL, United States, 60637
Location
Canton, OH, United States, 44710
Location
New York, NY, United States, 10065
Location
Houston, TX, United States, 77030
Location
San Francisco, CA, United States, 94143
Arms | Assigned Interventions |
---|---|
Experimental: Tremelimumab Tremelimumab | Drug: Tremelimumab Tremelimumab is to be administered as an IV solution, followed by observation. |
Placebo Comparator: Placebo Placebo | Drug: Placebo Placebo is to be administered as an IV solution, followed by observation. |
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